Bedside endoscopic inspection of colorectal anastomoses in the early postoperative period: a 2-center prospective feasibility study

David J. Nijssen; Roel Hompes; Jurriaan Tuynman; Jimme K. Wiggers; Willem A. Bemelman; Saidah Sahid; James Kinross; Wytze Laméris

doi:10.3393/ac.2024.00584.0083

Articles

Page Path: HOME > Ann Coloproctol > Ahead of print > Article

Original Article Bedside endoscopic inspection of colorectal anastomoses in the early postoperative period: a 2-center prospective feasibility study: David J. Nijssen^1,2, Roel Hompes^1,2, Jurriaan Tuynman^1,2, Jimme K. Wiggers^1,2, Willem A. Bemelman^1,2, Saidah Sahid³, James Kinross³, Wytze Laméris^1,2; DOI: https://doi.org/10.3393/ac.2024.00584.0083
Published online: April 14, 2025

¹Department of Surgery, Amsterdam UMC, Amsterdam, the Netherlands

²Cancer Treatment and Quality of Life, Cancer Center Amsterdam, Amsterdam, the Netherlands

³Department of Surgery and Cancer, Imperial College London, London, UK

Correspondence to: Wytze Laméris, MD, PhD Department of Surgery, Amsterdam UMC, Meibergdreef 9, Amsterdam 1105 AZ, the Netherlands Email: w.lameris@amsterdamumc.nl

• Received: August 28, 2024 • Revised: October 18, 2024 • Accepted: November 18, 2024

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

408 Views
21 Download

Full Article

Download PDF

Abstract
INTRODUCTION
METHODS
RESULTS
DISCUSSION
ARTICLE INFORMATION
REFERENCES

Abstract

Purpose
Early diagnosis of anastomotic leakage (AL) after colorectal surgery can reduce severe postoperative morbidity and ensure successful treatment. This study evaluated the feasibility of bedside endoscopic inspection of the anastomosis early postoperatively using a point-of-care digital rectoscope.
Methods
This prospective study was conducted at 2 tertiary centers. Patients who underwent minimally invasive or open sphincter-preserving surgery with creation of a colorectal or coloanal anastomosis were included. Data were collected from December 2022 to October 2023. Bedside anastomotic inspections were performed postoperative day (POD) 3 to 5 using a point-of-care digital rectoscope. The primary outcome was feasibility, defined as adequate clinical assessment of the anastomosis during bedside inspection. Secondary outcomes included patient tolerability, efficacy compared to other diagnostic methods, and clinical outcomes during 90 days of follow-up.
Results
In total, 35 patients were included. All bedside anastomotic inspections were carried out successfully. The examination showed complete visibility of the entire anastomosis in 30 patients (85.7%), with minimal discomfort reported by 3 (8.6%). No adverse events were recorded. AL occurred in 6 patients (17.1%), with 3 cases detected during bedside inspections between POD 3 and 5. Two leaks were detected without clinical or biochemical suspicion. Three patients with negative rectoscopy between POD 3 and 5 were later diagnosed with AL: 2 by a computed tomography scan and 1 by a bedside rectoscopy.
Conclusion
Bedside inspection of rectal anastomoses early postoperatively is feasible and tolerable for patients. Routine anastomotic inspections can detect early AL even without clear clinical or biochemical signs.
Keywords: Anastomotic leak; Early diagnosis; Endoscopy; Proctoscopy; Colorectal surgery

INTRODUCTION

Anastomotic leakage (AL) following colorectal surgery may occur in up to 20% of patients [1]. The early diagnosis of AL avoids severe sequelae such as chronic pelvic sepsis, a higher rate of major pelvic reinterventions, definitive stomas, and increased mortality [2–4]. Computed tomography (CT) scans with rectal contrast are widely implemented as a diagnostic modality for detecting AL. Endoscopy is less routinely employed in this context, although its diagnostic accuracy is comparable to that of CT [5]. These modalities are often deployed in response to clinical deterioration or guided by inflammatory biomarkers (e.g., C-reactive protein [CRP]) [6]. However, some cases of AL may be occult or present with minimal symptoms, particularly in diverted patients [7]. These occult leaks are associated with a delayed diagnosis, which can ultimately lead to chronic pelvic sepsis and subsequent major reoperations with permanent stomas [8]. Consequently, relying solely on CRP levels and clinical signs of infection before considering additional diagnostic modalities may be insufficient. A meta-analysis showed that CRP has a sensitivity of 79%, which implies a 21% rate of missed diagnoses [9]. The predictive value of CRP in diverted patients is potentially even lower, but this has not yet been documented in the literature. Combining diagnostic modalities may reduce the number of missed diagnoses and the associated morbidity.

Endoscopic assessment of the anastomosis in the early postoperative period may prove as a beneficial addition for patients, especially for those with occult AL. However, the widespread implementation of this technique is challenging due to logistics and costs. In a prospective cross-sectional study, the endoscopic evaluation of rectal anastomoses between days 5 and 8 after surgery in 90 clinically unremarkable patients led to the diagnosis of 11 additional cases (12.2%) of AL [10]. The potential benefit of early detection is further emphasized by the associated increased success rate of AL treatment. Early initiation of therapy (≤21 days) leads to an increase in healed and functional anastomoses compared to later initiation of treatment [11]. In addition, AL has a negative impact on oncological outcomes, particularly in cases with a later diagnosis [12].

Providing routine endoscopy for patients after restorative colorectal resection places a significant demand on the endoscopy capacity; therefore, the availability of a point-of-care rectoscopy device allows endoscopic examination to be performed directly at the bedside [13]. This enables the surgical team to routinely assess the anastomosis in the early postoperative period on the ward, without needing access to the endoscopy unit. We hypothesized that rigid endoscopic evaluation of rectal anastomoses in the early postoperative period would be feasible and could improve early diagnosis of AL or detect changes indicative of anastomotic failure, such as ischemia, congestion, or hematomas [10, 14].

A prospective study was conducted at 2 sites to assess the feasibility of bedside endoscopic evaluation of colorectal and coloanal anastomoses in the early postoperative period.

METHODS

Ethics statement

The Institutional Review Board of Amsterdam UMC approved the study protocol and confirmed that the Medical Research Involving Human Subjects Act (WMO) did not apply (No. W22_416 # 22.522). Ethical approval was also obtained from the Imperial College London Research Ethics Committee (No. REC 19/LO/0185). Written informed consents for recording and using the study data were obtained from the patients.

Study design and setting

This multicenter, prospective cohort study was conducted at 2 tertiary referral centers. At both centers, bedside endoscopic anastomotic inspection was implemented in the postoperative clinical care pathway of patients undergoing rectal surgery. Data were collected from patients treated at the Amsterdam UMC (Amsterdam, the Netherlands) and the Imperial College London (London, UK). The study period was between December 2022 and October 2023. The STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) reporting guideline [15] was used to structure the article.

Participants

The study included participants with rectal anastomoses who underwent minimally invasive or open sphincter-preserving surgery. The eligibility criteria were defined as follows: (1) ≥18 years of age; (2) the participant underwent minimally invasive or open (sphincter-preserving) surgery with construction of a colorectal or coloanal anastomosis; and (3) adequate comprehension of the Dutch or English language. Patients were excluded if they refused participation in the study or if they denied permission for endoscopic assessment of the anastomosis on the wards.

Outcome variables and definitions

The primary outcome was the feasibility of conducting a bedside anastomotic inspection on postoperative day (POD) 3 to 5. Feasibility was defined as adequate and complete visual assessment of the anastomosis. Secondary outcomes included patient tolerability, adverse events related to endoscopic examinations, efficacy compared to the other employed diagnostic modalities, time to treatment initiation, and surgical outcomes (e.g., AL, mortality, ostomy rate, therapy for AL). AL was defined in accordance with the International Study Group of Rectal Cancer (ISREC) definition [2]: “A defect of the intestinal wall integrity at the colorectal or colo-anal anastomotic site leading to a communication between the intra- and extraluminal compartments.” This was determined by endoscopy, CT imaging with rectal contrast, during inspection at the operating room, or by a combination of these modalities. Patient tolerance was assessed qualitatively, with clinicians asking patients to classify their discomfort as “no (notable) discomfort,” “mild discomfort,” or “severe discomfort.” Efficacy was evaluated by comparing the number of leaks detected during bedside inspections 3 to 5 days after surgery with those identified during later postoperative stages by CT and flexible endoscopy. The results of the bedside endoscopic anastomotic inspections were also compared to those of flexible sigmoidoscopy when both examinations were available. Perioperative patient characteristics relevant to the risk for AL were collected. Tumor characteristics were assessed based on the TNM staging in the TNM Classification of Malignant Tumours, 8th Edition by the Union for International Cancer Control (UICC) [16].

Data were recorded in (electronic) case report forms created by Castor’s electronic data capture (EDC, Castor) [17]. The database comprised patient (baseline) characteristics, medical history, specific surgical history, surgical details, perioperative diagnostic tests, and morphological features specified during endoscopic examinations, such as mucosal changes or anastomotic integrity. Follow-up data were collected until POD 90.

Standard clinical management of patients

At both centers, patients routinely received preoperative mechanical bowel preparation and intravenous antibiotic prophylaxis on induction. In addition, Amsterdam UMC patients were administered oral selective digestive decontamination during 3 days prior to surgery. Prior to anastomotic formation, Amsterdam UMC conducted routine fluorescence angiography, and both centers evaluated the integrity intraoperatively through (reverse) air leak testing and examination of anastomotic doughnuts. Both centers followed a "selective diversion" policy, where patients generally did not receive a diverting ostomy unless there was a clear combination of preoperative and/or intraoperative risk factors for AL. Both postoperative care protocols adhered to Enhanced Recovery After Surgery (ERAS) principles and involved CRP-guided imaging with CRP measurements taken on POD 3 and 4. A CT scan with rectal contrast is requested in case of a high CRP level on POD 3 or a rising trend on POD 4, and complemented with a flexible sigmoidoscopy for an inconclusive CT scan. For patients with a diverting ostomy created during initial surgery, Amsterdam UMC performed a flexible sigmoidoscopy 2 weeks postoperatively to assess the integrity of the anastomosis. This flexible sigmoidoscopy was carried out by a gastroenterologist in the presence of the operating surgeon.

Bedside endoscopic anastomotic inspection

All bedside anastomotic inspections were performed using a LumenEye X1 rectoscope (SurgEase Innovations Ltd), which enabled the team to carry out anastomotic inspections at the bedside (Figs. 1, 2). The examination was conducted by the attending colorectal surgeon or a senior surgical resident. Prior to the anastomotic inspection, a digital rectal examination was performed. The anastomotic inspection took place on either POD 3, 4, or 5, with planned discharge on POD 4 or 5. Patients were examined in the left lateral position. A disposable rectoscope tube with a diameter of 14 mm was attached to the scope, through which the rectoscope camera was advanced toward the (ano)rectum. No additional anesthetics or bowel preparation were administered prior to the examination. In patients without a diverting ileostomy, the anastomosis was irrigated through the rectoscope tube lumen by disconnecting the handle and using a 60-mL syringe with water or saline. Each examination was assessed for the level of visibility of the entire anastomosis (complete or incomplete), distance of the anastomosis to the anorectal junction (ARJ), anastomotic integrity, and mucosal healing.

Statistical analysis

Statistical analysis was performed using IBM SPSS ver. 26.0 (IBM Corp). Data were adapted from the electronic data capturing forms in Castor EDC. Patient (baseline) characteristics are displayed as either mean±standard deviation or median with interquartile range (IQR) based on the distribution. Since this was a feasibility study, we performed no statistical power analysis.

RESULTS

Participants

A total of 35 patients were included in the study. Table 1 describes the patient characteristics. The median age was 65 years (IQR, 57–72 years), and the majority were male (n=20, 57.1%). The most common surgical indication was primary rectal cancer (n=31, 88.6%), followed by diverticular disease (n=2. 5.7%), ovarian cancer (n=1, 2.9%), and Hartmann procedure reversal (n=1, 2.9%). Relatedly, most patients underwent a partial or total mesorectal excision (TME; n=32, of whom 1 patient had primary ovarian cancer). Neoadjuvant therapy was administered to 13 patients (37.1%), including radiotherapy in 11 (31.4%). A diverting ostomy was created during index surgery in 15 patients (42.9%). The median distance of the anastomosis to the ARJ in all 35 patients was 3 cm (IQR, 1–10 cm). All patients completed the 3-month follow-up period.

Primary and secondary outcomes

The bedside anastomotic inspections were successfully executed in all enrolled patients. Complete visualization of the entire anastomosis was achieved in 30 patients (85.7%). The remaining examinations were constrained by either limited scope maneuverability or incomplete irrigation of the rectum. Incomplete visualization only occurred in patients with an anastomosis <5 cm from the ARJ. Complete visualization in patients without a diverting stoma was dependent on adequate irrigation of the rectum. The examinations were rated as without discomfort in 32 patients (91.4%), while 3 patients (8.6%) experienced mild discomfort. No relationship between discomfort and the level of the anastomosis was observed. There were no adverse events related to the endoscopic examinations.

Table 2 describes the findings and clinical outcomes of patients who underwent bedside anastomotic inspections. Six patients (17.1%) were diagnosed with AL in the 90-day follow-up period (Fig. 3). All cases of AL were found in anastomoses <5 cm from the ARJ. Out of the total 6 cases, 3 leaks were detected during the bedside inspections carried out between POD 3 and 5. These 3 leaks were found after TME procedures. In relation to the other employed diagnostics, 2 leaks were only detected by a CT scan or flexible sigmoidoscopy, and 1 was also detected using bedside endoscopy but beyond the index admission.

In total, 3 patients were suspected of having AL based on clinical signs and biochemical markers. Of these, 2 were ultimately diagnosed with AL—1 of whom was missed during bedside inspection but later confirmed via CT scan (Fig. 3). The third patient, despite clinical suspicion, showed no signs of AL on CT with rectal contrast and had a negative bedside anastomotic inspection. Out of the 6 leaks, 2 identified during the early anastomotic inspections were diagnosed in absence of clear clinical suspicion. One involved a 65-year-old man who underwent robot-assisted transanal TME (TaTME), which was converted to open surgery due to intraoperative bleeding and required a diverting ileostomy. In the postoperative course, the patient’s CRP level decreased from 170 mg/L (POD 3) to 120 mg/L (POD 4), with no other clinical signs of infection. On POD 5, the bedside anastomotic inspection revealed a clear anastomotic defect (Fig. 4B). The other was a 56-year-old man who underwent laparoscopic TaTME without a diverting ostomy. A CT scan with rectal contrast was performed on POD 5, indicated by a CRP elevation from 54 mg/L (POD 3) to 120 mg/L (POD 4). The CT scan showed no evidence of contrast extravasation and was therefore inconclusive. The subsequent bedside anastomotic inspection on the same day showed a small anterior defect of the anastomosis (Fig. 4C).

Out of the 32 negative bedside anastomotic inspections, 3 patients were later diagnosed with AL (Fig. 3). One patient was a 50-year-old woman with an elevated CRP of 378 mg/L on POD 3 following laparoscopic TaTME. The bedside anastomotic inspection was hindered by moderate visibility due to stool in the field of view that could not be sufficiently evacuated by irrigation. A subsequent CT scan on POD 4 revealed an anastomotic defect, which was confirmed in the operating room. One case of late diagnosis of leakage was in a 63-year-old man who underwent robotic TaTME with a diverting ileostomy. The patient had uncomplicated clinical recovery and a negative bedside anastomotic inspection 5 days after surgery, following which he was discharged. An anastomotic defect was diagnosed by bedside anastomotic inspection at the outpatient clinic on POD 20 in the absence of clinical symptoms. The remaining late diagnosis of AL was in a 58-year-old man who underwent laparoscopic TaTME with a diverting ileostomy. A negative bedside anastomotic inspection was performed on POD 5. A CT scan was conducted due to perianal pain and increasing CRP levels on POD 7, but was also negative for AL as was flexible sigmoidoscopy on POD 17. On POD 54, the patient presented with perianal pain, blood loss, and biochemical signs of infection. AL was confirmed by a CT scan and subsequent flexible sigmoidoscopy.

Flexible sigmoidoscopy

Twenty anastomoses (57.1%) were examined by flexible sigmoidoscopy in addition to bedside rectoscopy. All of these examinations were consistent with the bedside assessment for anastomotic defects in the early postoperative period. One of the flexible sigmoidoscopies was performed on the same day after the suggestion of leakage during the bedside examination. The remaining were scheduled for 2 to 3 weeks after surgery at the endoscopy unit for assessing the anastomosis.

Treatment of AL

Treatment for AL was initiated after a median of 5 days (IQR, 4–29 days) after surgery. Patients without a diverting ostomy were defunctioned if AL was detected. AL was treated by endoscopic vacuum-assisted surgical closure (EVASC) as previously described [11]. The therapy involves a series of endoscopic vacuum-sponge placements in the abscess cavity, after which transanal closure of the defect over an active suction drain is performed once the cavity is granulating and clean. Complete healing of the anastomosis was achieved in 5 out of 6 patients at the last follow-up, as confirmed by sigmoidoscopy and CT with contrast enema.

DISCUSSION

This prospective study demonstrates the feasibility of performing a bedside endoscopic inspection of the anastomosis in the immediate postoperative period, to aid in the early detection of AL. A complete visual inspection of the anastomosis was feasible in most patients and was well tolerated without any iatrogenic injuries. This approach enabled early identification of anastomotic defects, even in the absence of definitive clinical or biochemical signs, allowing the early initiation of therapy. Not all anastomotic defects were detected by early bedside anastomotic inspections, and a negative inspection did not rule out the possibility of a late or missed leak in this first feasibility study. The protocol for the detection and active treatment of anastomotic leaks using EVASC resulted in complete healing in 5 out of 6 ALs.

An effective protocol for the detection and treatment of AL after colorectal surgery is important to avoid chronic AL, which often requires major redo surgery that is not only associated with physical and psychological stress, but also with high hospital costs [18]. A multimodal and sequential strategy seems most effective, using laboratory results, CT, and endoscopy. The development of AL is variable, and the absence of clinical symptoms or a negative test result in the early postoperative period does not rule out the presence of AL, especially after TME with a diverting ileostomy, as also shown in this study. Recent prospective data have demonstrated the diagnostic value of early postoperative endoscopic assessment of rectal anastomosis for detecting anastomotic defects [10]. Axt et al. [10] conducted a study in which only patients deemed low risk for AL (e.g., CRP <18 mg/dL, body temperature <38.5 °C, and functioning gastrointestinal transit) were offered flexible endoscopic inspection between POD 5 and 8 after rectal surgery. Despite the low-risk profile, 11 leaks (11.2%) were identified in 90 patients and 31% of the patients had a change in management. Our initial experiences with bedside endoscopy support these findings, revealing the detection of AL in patients without clear clinical suspicion at a very early point in the postoperative course. In contrast to Axt et al. [10], who exclusively included clinically unremarkable patients, our series comprised individuals regardless of clinical suspicion. The deployment of a point-of-care device enabled anastomotic inspections without reliance on flexible endoscopy capacity, making it readily available for all patients. The practicality of conducting routine flexible endoscopy is often hindered by hospital logistics and additional referrals. Considering these challenges, the implementation of a point-of-care endoscopy system to use on the ward may offer greater potential for wider clinical adoption and significantly increase the early detection rate of AL. At our institutions, this approach has reduced the threshold for endoscopic inspections, with the potential to lower morbidity by early interventions.

Early diagnosis of AL is crucial since evidence suggests that treatment success and oncological outcomes depend on time to diagnosis and initiation of treatment [11, 12]. Relatedly, it is important to discuss the added value of conducting endoscopic examinations in an early postoperative window compared to more widely established diagnostic pathways. As reflected in the study results, not all cases of AL could be detected in this early period; 2 leaks manifested beyond the index hospitalization despite prior negative diagnostic findings. Half of the leaks (3 of 6) were detected with bedside rectoscopy between the 3- to 5-day window after surgery. Furthermore, 1 leak was initially missed by this approach and could be addressed by CRP-guided CT imaging the following day. Notably, this was one of the first cases, suggesting a possible learning curve for performing a thorough inspection using this method. Thus, while early endoscopy appears to be a valuable tool that can lead to earlier initiation of treatment in selected patients, it should be used in conjunction with established diagnostic modalities.

The greatest potential of early endoscopy is for patients with an occult presentation of AL or with minimal symptoms, who may be overlooked by the established CRP-guided imaging workflows. Occult AL may manifest without clinical symptoms, but can cause complex tissue damage through chronic, low-grade presacral inflammation over an extended period [19]. This mainly occurs in patients with a diverting ostomy, where disruption of the anastomosis may not coincide with clinical signs. In relation to this, the use of early endoscopy is probably particularly beneficial in defunctioned patients, whereas in non-defunctioned patients the majority of AL cases will be detected by CRP-guided imaging. By using protocols guided solely by clinical signs, patients with initially asymptomatic AL often face a delayed diagnosis. Many patients are diagnosed beyond 30 days or even 3 months, which further indicates that symptomatology may only develop in a later stage [1, 20]. Accordingly, the reported AL rate varies greatly, between nearly 0% and 20%, and the actual rate may be underreported in the literature [1, 21–26]. The leakage rate in this study appears relatively high, however, must be interpreted in the context of a high-risk population with very low-level anastomoses and use of neoadjuvant radiotherapy. Moreover, the diagnostic pathway in this study was specifically aimed at detecting early AL with minimal clinical signs that could be missed by CRP-guided imaging alone. The current results reflect that a more systematic integration of endoscopic examinations has the potential to enhance the earlier detection of early AL.

While the use of bedside rectoscopy makes endoscopic inspection of anastomoses available for all patients before discharge, it has inherent limitations when compared to flexible sigmoidoscopy. The portable endoscope is rigid, limiting luminal maneuverability and potentially impacting the field of view. This is reflected by the fact that incomplete anastomosis visualization only occurred in patients with an anastomosis <5 cm from the ARJ, potentially influencing the detection rate. Additionally, bowel preparation for bedside inspection was not standardized, which could hinder complete visualization if proper irrigation of the rectum is not achieved. Flexible endoscopy also allows immediate endoscopic intervention once a defect is detected. Furthermore, rigid endoscopic evaluation may also be experienced as more uncomfortable than flexible endoscopy [27]. It is worth noting that in future studies, a patient-reported comfort score is preferable, given evidence suggesting that clinicians may assign higher comfort scores than patients do [28]. Another aspect that warrants exploration in subsequent studies is cost-effectiveness. It remains unclear to what extent the additional costs associated with implementing bedside inspections may be offset by a reduction in costs due to prevented morbidity from missed diagnoses.

Iatrogenic injuries during endoscopic evaluations did not occur in the study. A careful digital examination to determine the route to the anastomosis, followed by rectoscopy performed by colorectal surgeons or senior surgical residents, appears to be a safe approach. However, every diagnostic endoscopic examination carries a risk for iatrogenic injuries and should be conducted by skilled and experienced physicians to minimize these risks.

Several limitations of this feasibility study should be addressed. First, the study contained a small sample size. Therefore, a reliable estimate of diagnostic accuracy could not be established. Second, conducting the study at 2 centers introduced variations in postoperative management protocols for detecting AL, potentially introducing bias. Third, we were unable to include consecutive cases in this first series due to logistical constraints, including limited staff availability during weekend discharges and periods of reduced attendance. This may have introduced selection bias into the study. Lastly, the generalizability of the results is limited due to the inclusion of primarily high-risk patients with low-level anastomoses, which affects the pretest probability of AL and may complicate a complete visualization of the anastomoses during inspection. However, we have observed that with proper irrigation, a complete inspection is feasible even for low anastomoses. Additionally, the inclusion of patients with different primary pathologies and the variable use of neoadjuvant therapy introduces a diversity in AL risk. This also affects the generalizability of the results. Nevertheless, this is the first study to report on the routine use of early bedside endoscopy for the detection of AL and is valuable for building evidence regarding this approach. The ongoing REAL study (ClinicalTrials.gov identifier: NCT06493565) will be able to clarify the effects of patient selection in a larger cohort when using this method. Although global consensus regarding early detection of AL does not exist, protocols aiming for the proactive detection of early leaks seem most reasonable given that delayed diagnosis is associated with poorer outcomes [29, 30].

Subsequent studies should investigate the diagnostic accuracy and impact on clinical outcomes of early bedside endoscopy. It remains to be explored whether a postoperative protocol that includes early anastomotic inspection in the immediate postoperative period is superior to established protocols that rely solely on clinical signs, imaging, and endoscopy at a later stage. The clinical value of this approach should be compared in patients with and without a diverting ileostomy in order to fully justify its use in all patients.

In conclusion, bedside inspection of rectal anastomoses 3 to 5 days after surgery is feasible and offers a tolerable examination setting for patients. The implementation of routine anastomosis inspections as part of the postoperative protocol for the detection of AL can lead to the early detection of AL in absence of clear clinical or biochemical suspicion.

ARTICLE INFORMATION

Conflict of interest

James Kinross is a shareholder in SurgEase Innovations Ltd. No other conflict of interest relevant to this article was reported.

Funding

Roel Hompes has received funding from SurgEase Innovations Ltd for the role of principal investigator of this study. All fees were paid to the institution.

Author contributions

Conceptualization: WL, RH; Data curation: RH, JT, JKW, WAB, SS, JK; Formal analysis: all authors; Funding acquisition: RH; Investigation: RH, JT, JKW, WAB, SS, JK; Methodology: WL, RH; Project administration: DJN; Supervision: DJN; Writing–original draft: DJN; Writing–review & editing: all authors. All authors read and approved the final manuscript.

Fig. 1.

The LumenEye X1 endoscope (SurgEase Innovations Ltd) connected to the digital tablet display in the docking station.

Fig. 2.

The LumenEye X1 endoscope (SurgEase Innovations Ltd) with the disposable tube connected ready for clinical use.

Fig. 3.

Flowchart displaying the flow of patients from recruitment to diagnostic process leading to confirmation of anastomotic leakage status. POD, postoperative day; CT, computed tomography.

Fig. 4.

Bedside endoscopic examinations using the LumenEye X1 endoscope (SurgEase Innovations Ltd). (A) Bedside anastomosis inspection on postoeperative day (POD) 4 with circumferential normal-looking mucosa with minor congestion surrounding anastomosis. (B) Bedside anastomotic inspection on POD 5 in a patient with low-infection parameters and absent clinical signs. (C) Bedside anastomotic inspection on POD 4 in a patient with mildly elevated infection parameters. The arrow points to air bubbles and fluid indicative of anastomotic leakage.

Table 1.

Patient characteristics and surgical details

Characteristic	Value (n=35)
Sex
Male	20 (57.1)
Female	15 (42.9)
Age (yr)	65 (57–72)
ASA physical status
I, II	29 (82.9)
III, IV	6 (17.1)
Body mass index (kg/m²)	25.2±3.7
Indications for surgery
Rectal cancer	31 (88.6)
Diverticular disease	2 (5.7)
Locally advanced ovarian cancer	1 (2.9)
Hartmann procedure reversal	1 (2.9)
TNM staging^a (n=32)
I	8 (25.0)
II	9 (28.1)
III	12 (37.5)
IV	3 (9.4)
Neoadjuvant treatment (n=32)
None	19 (59.4)
Chemoradiotherapy	7 (21.9)
Chemotherapy	2 (6.3)
Radiotherapy	4 (12.5)
Surgical detail
Surgical procedure
TME	5 (14.3)
TaTME	18 (51.4)
PME	11 (31.4)
Hartmann procedure reversal	1 (2.9)
Surgical approach
Open	2 (5.7)
Laparoscopic	22 (62.9)
Robot-assisted	10 (28.6)
Conversion to open	1 (2.9)
Diverting ostomy	15 (42.9)
Distance of anastomosis to ARJ (cm)	3 (1–10)

Values are presented as number (%), median (interquartile range), or mean±standard deviation. Percentages may not total 100 due to rounding.

ASA, American Society of Anesthesiologists; TME, total mesorectal excision; TaTME, transanal total mesorectal excision; PME, partial mesorectal excision; ARJ, anorectal junction.

^aAccording to the TNM Classification of Malignant Tumours, 8th Edition [16].

Table 2.

Findings during endoscopic examinations and clinical outcomes

Finding	Value (n=35)
Bedside endoscopic inspection of the anastomosis
Healing of the anastomosis on POD 3, 4, or 5
Suspected anastomotic leakage	3 (8.6)
Normal healing tendency	32 (91.4)
Uncertain	0 (0)
Level of visibility
Incomplete	5 (14.3)
Complete visualization	30 (85.7)
Level of discomfort during examination
No (notable) discomfort	32 (91.4)
Mild discomfort	3 (8.6)
Severe discomfort	0 (0)
Clinical outcome at 90 days after index surgery
Anastomotic leakage	6 (17.1)
Time to diagnosis (day)	5 (4–29)
Mortality	0 (0)

Values are presented as number (%) or median (interquartile range).

POD, postoperative day.

REFERENCES

1. Borstlap WA, Westerduin E, Aukema TS, Bemelman WA, Tanis PJ; Dutch Snapshot Research Group. Anastomotic leakage and chronic presacral sinus formation after low anterior resection: results from a large cross-sectional study. Ann Surg 2017;266:870–7. Article PubMed
2. Gessler B, Eriksson O, Angenete E. Diagnosis, treatment, and consequences of anastomotic leakage in colorectal surgery. Int J Colorectal Dis 2017;32:549–56. Article PubMed PMC PDF
3. Ponholzer F, Klingler CP, Gasser E, Gehwolf P, Ninkovic M, Bellotti R, et al. Long-term outcome after chronic anastomotic leakage following surgery for low rectal cancer. Int J Colorectal Dis 2022;37:1807–16. Article PubMed PMC PDF
4. Boström P, Haapamäki MM, Rutegård J, Matthiessen P, Rutegård M. Population-based cohort study of the impact on postoperative mortality of anastomotic leakage after anterior resection for rectal cancer. BJS Open 2018;3:106–11. Article PubMed PMC PDF
5. Chierici A, Granieri S, Frontali A. Diagnostic accuracy of water-soluble contrast enema, contrast-enema computed tomography and endoscopy in detecting anastomotic leakage after (Colo) proctectomy: a meta-analysis. Colorectal Dis 2023;25:1371–80. Article PubMed
6. Daams F, Wu Z, Lahaye MJ, Jeekel J, Lange JF. Prediction and diagnosis of colorectal anastomotic leakage: a systematic review of literature. World J Gastrointest Surg 2014;6:14–26. Article PubMed PMC
7. Matthiessen P, Hallböök O, Rutegård J, Simert G, Sjödahl R. Defunctioning stoma reduces symptomatic anastomotic leakage after low anterior resection of the rectum for cancer: a randomized multicenter trial. Ann Surg 2007;246:207–14. Article PubMed PMC
8. Bhama AR, Maykel JA. Diagnosis and management of chronic anastomotic leak. Clin Colon Rectal Surg 2021;34:406–11. Article PubMed PMC
9. Singh PP, Zeng IS, Srinivasa S, Lemanu DP, Connolly AB, Hill AG. Systematic review and meta-analysis of use of serum C-reactive protein levels to predict anastomotic leak after colorectal surgery. Br J Surg 2014;101:339–46. Article PubMed PDF
10. Axt S, Haller K, Wilhelm P, Falch C, Martus P, Johannink J, et al. Early postoperative endoscopic evaluation of rectal anastomoses: a prospective cross-sectional study. Surg Endosc 2022;36:8881–92. Article PubMed PMC PDF
11. Talboom K, Greijdanus NG, Ponsioen CY, Tanis PJ, Bemelman WA, Hompes R. Endoscopic vacuum-assisted surgical closure (EVASC) of anastomotic defects after low anterior resection for rectal cancer; lessons learned. Surg Endosc 2022;36:8280–9. Article PubMed PMC PDF
12. Denost Q, Rouanet P, Faucheron JL, Panis Y, Meunier B, Cotte E, et al. Impact of early biochemical diagnosis of anastomotic leakage after rectal cancer surgery: long-term results from GRECCAR 5 trial. Br J Surg 2021;108:605–8. Article PubMed PDF
13. Lewis JA, Khan S, Tilney HS, Wilson JM, Vitone LJ, Souvatzi M, et al. An observational analysis of a novel digital rectoscope. Dis Colon Rectum 2021;64:e728–34. Article PubMed
14. Sujatha-Bhaskar S, Jafari MD, Hanna M, Koh CY, Inaba CS, Mills SD, et al. An endoscopic mucosal grading system is predictive of leak in stapled rectal anastomoses. Surg Endosc 2018;32:1769–75. Article PubMed PDF
15. von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP, et al. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. J Clin Epidemiol 2008;61:344–9. Article PubMed
16. Brierley JD, Gospodarowicz MK, Wittekind C, editors. Union for International Cancer Control (UICC) TNM classification of malignant tumours. 8th ed. Wiley-Blackwell; 2016.
17. Castor. Electronic data capture (EDC) [Internet]. Castor; [cited 2023 Apr 4]. Available from: https://www.castoredc.com/electronic-data-capture-system/
18. Wienholts K, Nijssen DJ, Sharabiany S, Postma MJ, Tanis PJ, Laméris W, et al. Economic burden of pelvic sepsis after anastomotic leakage following rectal cancer surgery: a retrospective cost-of-illness analysis. Colorectal Dis 2024;26:1922–30. Article PubMed
19. van Koperen PJ, van der Zaag ES, Omloo JM, Slors JF, Bemelman WA. The persisting presacral sinus after anastomotic leakage following anterior resection or restorative proctocolectomy. Colorectal Dis 2011;13:26–9. Article PubMed
20. Wienholts K, Sharabiany S, de Wilt JH, Hompes R, Tanis PJ. Reactivation leakages following stoma reversal after rectal cancer surgery: an underestimated problem. BJS Open 2024;8:zrad150.Article PubMed PMC PDF
21. Platell C, Barwood N, Dorfmann G, Makin G. The incidence of anastomotic leaks in patients undergoing colorectal surgery. Colorectal Dis 2007;9:71–9. Article PubMed
22. Ortiz H, Wibe A, Ciga MA, Kreisler E, Garcia-Granero E, Roig JV, et al. Multicenter study of outcome in relation to the type of resection in rectal cancer. Dis Colon Rectum 2014;57:811–22. Article PubMed
23. Irvin TT, Goligher JC. Aetiology of disruption of intestinal anastomoses. Br J Surg 1973;60:461–4. Article PubMed PDF
24. Peeters KC, Tollenaar RA, Marijnen CA, Klein Kranenbarg E, Steup WH, Wiggers T, et al. Risk factors for anastomotic failure after total mesorectal excision of rectal cancer. Br J Surg 2005;92:211–6. Article PubMed
25. Gorgun E, Remzi FH. Complications of ileoanal pouches. Clin Colon Rectal Surg 2004;17:43–55. Article PubMed PMC
26. Heuthorst L, Wasmann KA, Reijntjes MA, Hompes R, Buskens CJ, Bemelman WA. Ileal pouch-anal anastomosis complications and pouch failure: a systematic review and meta-analysis. Ann Surg Open 2021;2:e074. Article PubMed PMC
27. Rao VS, Ahmad N, Al-Mukhtar A, Stojkovic S, Moore PJ, Ahmad SM. Comparison of rigid vs flexible sigmoidoscopy in detection of significant anorectal lesions. Colorectal Dis 2005;7:61–4. Article PubMed
28. Rafferty H, Hutchinson J, Ansari S, Smith LA. PWE-040 comfort scoring for endoscopic procedures: who is right–the endoscopist, the nurse or the patient? Gut 2014;63(Suppl 1): A139–40. Article
29. McDermott FD, Heeney A, Kelly ME, Steele RJ, Carlson GL, Winter DC. Systematic review of preoperative, intraoperative and postoperative risk factors for colorectal anastomotic leaks. Br J Surg 2015;102:462–79. Article PubMed PDF
30. Alves A, Panis Y, Trancart D, Regimbeau JM, Pocard M, Valleur P. Factors associated with clinically significant anastomotic leakage after large bowel resection: multivariate analysis of 707 patients. World J Surg 2002;26:499–502. Article PubMed PDF

Figure & Data

References

Citations

Citations to this article as recorded by

PubReader

Cite this Article

Cite this Article: export Copy Download Format; Close

Download Citation

Download a citation file in RIS format that can be imported by all major citation management software, including EndNote, ProCite, RefWorks, and Reference Manager.

Format:

RIS — For EndNote, ProCite, RefWorks, and most other reference management software
BibTeX — For JabRef, BibDesk, and other BibTeX-specific software

Include:

Citation for the content below
Citation and abstract for the content below

Bedside endoscopic inspection of colorectal anastomoses in the early postoperative period: a 2-center prospective feasibility study

DOI: https://doi.org/10.3393/ac.2024.00584.0083

XML Download

Figure

Related articles

Recurrence after endoscopic resection of small rectal neuroendocrine tumors: a retrospective cohort study

Bedside endoscopic inspection of colorectal anastomoses in the early postoperative period: a 2-center prospective feasibility study

Fig. 1. The LumenEye X1 endoscope (SurgEase Innovations Ltd) connected to the digital tablet display in the docking station.

Fig. 2. The LumenEye X1 endoscope (SurgEase Innovations Ltd) with the disposable tube connected ready for clinical use.

Fig. 3. Flowchart displaying the flow of patients from recruitment to diagnostic process leading to confirmation of anastomotic leakage status. POD, postoperative day; CT, computed tomography.

Fig. 4. Bedside endoscopic examinations using the LumenEye X1 endoscope (SurgEase Innovations Ltd). (A) Bedside anastomosis inspection on postoeperative day (POD) 4 with circumferential normal-looking mucosa with minor congestion surrounding anastomosis. (B) Bedside anastomotic inspection on POD 5 in a patient with low-infection parameters and absent clinical signs. (C) Bedside anastomotic inspection on POD 4 in a patient with mildly elevated infection parameters. The arrow points to air bubbles and fluid indicative of anastomotic leakage.

Fig. 1.

Fig. 2.

Fig. 3.

Fig. 4.

Bedside endoscopic inspection of colorectal anastomoses in the early postoperative period: a 2-center prospective feasibility study

Characteristic	Value (n=35)
Sex
Male	20 (57.1)
Female	15 (42.9)
Age (yr)	65 (57–72)
ASA physical status
I, II	29 (82.9)
III, IV	6 (17.1)
Body mass index (kg/m²)	25.2±3.7
Indications for surgery
Rectal cancer	31 (88.6)
Diverticular disease	2 (5.7)
Locally advanced ovarian cancer	1 (2.9)
Hartmann procedure reversal	1 (2.9)
TNM staging^a (n=32)
I	8 (25.0)
II	9 (28.1)
III	12 (37.5)
IV	3 (9.4)
Neoadjuvant treatment (n=32)
None	19 (59.4)
Chemoradiotherapy	7 (21.9)
Chemotherapy	2 (6.3)
Radiotherapy	4 (12.5)
Surgical detail
Surgical procedure
TME	5 (14.3)
TaTME	18 (51.4)
PME	11 (31.4)
Hartmann procedure reversal	1 (2.9)
Surgical approach
Open	2 (5.7)
Laparoscopic	22 (62.9)
Robot-assisted	10 (28.6)
Conversion to open	1 (2.9)
Diverting ostomy	15 (42.9)
Distance of anastomosis to ARJ (cm)	3 (1–10)

Finding	Value (n=35)
Bedside endoscopic inspection of the anastomosis
Healing of the anastomosis on POD 3, 4, or 5
Suspected anastomotic leakage	3 (8.6)
Normal healing tendency	32 (91.4)
Uncertain	0 (0)
Level of visibility
Incomplete	5 (14.3)
Complete visualization	30 (85.7)
Level of discomfort during examination
No (notable) discomfort	32 (91.4)
Mild discomfort	3 (8.6)
Severe discomfort	0 (0)
Clinical outcome at 90 days after index surgery
Anastomotic leakage	6 (17.1)
Time to diagnosis (day)	5 (4–29)
Mortality	0 (0)

Table 1. Patient characteristics and surgical details

Values are presented as number (%), median (interquartile range), or mean±standard deviation. Percentages may not total 100 due to rounding.

ASA, American Society of Anesthesiologists; TME, total mesorectal excision; TaTME, transanal total mesorectal excision; PME, partial mesorectal excision; ARJ, anorectal junction.

According to the TNM Classification of Malignant Tumours, 8th Edition [16].

Table 2. Findings during endoscopic examinations and clinical outcomes

Values are presented as number (%) or median (interquartile range).

POD, postoperative day.