The efficacy of mosapride on recovery of intestinal motility after elective colorectal cancer surgery: a randomized controlled trial

Tharin Thampongsa; Bensita Saengsawang; Chairat Supsamutchai; Chumpon Wilasrusmee; Jakrapan Jirasiritham; Puvee Punmeechao; Visarat Palitnonkiat; Napaphat Poprom; Pattawia Choikrua; Pongsasit Singhathas

doi:10.3393/ac.2024.00892.0127

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Original Article ERAS The efficacy of mosapride on recovery of intestinal motility after elective colorectal cancer surgery: a randomized controlled trial: Tharin Thampongsa¹, Bensita Saengsawang¹, Chairat Supsamutchai¹, Chumpon Wilasrusmee¹, Jakrapan Jirasiritham¹, Puvee Punmeechao¹, Visarat Palitnonkiat¹, Napaphat Poprom², Pattawia Choikrua¹, Pongsasit Singhathas¹; Annals of Coloproctology 2025;41(3):232-238.
DOI: https://doi.org/10.3393/ac.2024.00892.0127
Published online: June 25, 2025

¹Department of Surgery, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand

²Faculty of Public Health, Chiang Mai University, Chiang Mai, Thailand

Correspondence to: Chairat Supsamutchai, MD Department of Surgery, Faculty of Medicine Ramathibodi Hospital, Mahidol University, 270 Rama VI Rd, Phayathai, Rachathewi, Bangkok 10400, Thailand Email: chairat.sus@mahidol.ac.th

• Received: December 3, 2024 • Revised: February 12, 2025 • Accepted: February 13, 2025

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.

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Abstract
INTRODUCTION
METHODS
RESULTS
DISCUSSION
ARTICLE INFORMATION
SUPPLEMENTARY MATERIALS
REFERENCES

Abstract

Purpose
Postoperative ileus is the physiologic hypomotility of the gastrointestinal tract that occurs immediately after abdominal surgery. Mosapride citrate is known to enhance gastrointestinal motility. This study aimed to evaluate mosapride’s impact on postoperative ileus and gastrointestinal motility in patients undergoing elective colorectal surgery.
Methods
Forty-four patients with colorectal cancer undergoing surgery at Ramathibodi Hospital between July 2021 and August 2022 were randomly assigned to either a mosapride group or a control group. The mosapride group received 5 mg of mosapride via the enteric route with 50 mL of water 3 times daily, beginning on postoperative day 1, while the control group received 5 mg of a placebo with 50 mL of water on the same schedule. A single investigator, blinded to the treatment assignments in this triple-blind study, evaluated the postoperative time to the first bowel sound and passage of flatus. Secondary outcomes included the time to step diet, length of postoperative hospital stay, and adverse effects.
Results
There were 23 patients in the control group and 21 in the mosapride group. There were no significant differences in baseline patient characteristics between the 2 groups. The mosapride group demonstrated significantly shorter times to the first bowel sound (26 hours vs. 50 hours, P=0.004) and passage of flatus (40 hours vs. 70 hours, P=0.003).
Conclusion
Mosapride significantly improved the recovery of gastrointestinal motility and reduced the length of hospital stay without causing any serious adverse effects in patients undergoing elective colorectal surgery.
Trial registration
ClinicalTrials.gov identifier: NCT04905147
Keywords: Ileus; Colorectal surgery; Randomized controlled trials; Treatment outcome

INTRODUCTION

Postoperative ileus (POI) is one of the most common causes of prolonged hospital stays following abdominal surgery [1, 2]. Characterized by nausea, vomiting, inability to tolerate an oral diet, abdominal distension, and delayed passage of flatus and stool, POI causes significant patient discomfort [3]. It has been shown to slow recovery, increase postoperative morbidity, and elevate healthcare resource utilization [4]. POI is defined as the physiologic hypomotility of the gastrointestinal tract that occurs immediately after major abdominal or nonabdominal surgery. Its multifactorial pathophysiology involves sympathetic neural reflexes, local and systemic inflammatory mediators, and alterations in various neural and hormonal transmitters. Specifically, sympathetic (adrenergic) hyperactivity reduces propulsive motility and increases sphincter tone, whereas parasympathetic (cholinergic) hypoactivity decreases gastrointestinal motility [5–7]. Traditional multimodal approaches for resolving POI include opioid minimization, early ambulation, early feeding, nasogastric tube insertion, epidural analgesia, and laparoscopic surgery [2, 8]. Pharmacological strategies that enhance excitatory activity have primarily involved parasympathomimetic agents, which boost cholinergic transmission. Various agents, including erythromycin, metoclopramide, and other cholinergic drugs, have been evaluated for their ability to improve gastrointestinal motility [9, 10]. Cisapride, a 5-hydroxytryptamine-4 (5-HT4) receptor agonist, acts as an indirect parasympathomimetic by stimulating serotonin receptors and enhancing acetylcholine release. Although a systematic review found that cisapride significantly reduced POI, serious cardiovascular effects such as QT interval prolongation, torsades de pointes, and ventricular fibrillation led to its withdrawal from both the United States and global markets in 2000 [11, 12].

Mosapride citrate is another prokinetic drug that selectively activates 5-HT4 receptors, thereby stimulating serotonin receptors in the digestive tract. It enhances acetylcholine release to promote motility in both the upper (stomach and duodenum) and lower (colon) digestive tracts, as well as gastric emptying, without inducing cardiac side effects [13–15]. In clinical trials, adverse reactions were observed in 4% of cases and included diarrhea (1.8%), dry mouth (0.5%), malaise (0.3%), increased eosinophils (1.1%), elevated triglycerides (1.0%), and increased transaminases (0.4%). Notably, mosapride acts selectively on the gastrointestinal tract and does not produce serious arrhythmic side effects or extrapyramidal symptoms. It has proven effective in improving overall symptoms in patients with various gastrointestinal disorders, including chronic gastritis, gastroesophageal reflux disease, and functional dyspepsia [16–18]. However, few studies have examined the effect of mosapride on POI following abdominal cancer surgery [19].

In this prospective randomized controlled study, we investigated the effect of mosapride on postoperative gastrointestinal motility in patients undergoing both open and laparoscopic colectomy.

METHODS

Ethics statement

The study was approved by the Ethics Committee of the Faculty of Medicine, Ramathibodi Hospital, Mahidol University (No. COA.MURA2021/328) and registered on ClinicalTrials.gov (identifier: NCT04905147). The trial was conducted according to the original protocol, and written informed consent was obtained from all participants. For minors under 18 years of age, both the patients and their parents were informed about the study, and one of the parent provided written consent.

Study design

This single-center, randomized controlled, triple-blind trial employed a 2-arm parallel design to assess the efficacy of the prokinetic agent mosapride on gastrointestinal recovery in patients undergoing colorectal cancer surgery.

Participants

Forty-six patients with colorectal cancer scheduled to undergo colorectal surgery under general anesthesia at Ramathibodi Hospital (Bangkok, Thailand) from July 1, 2021, to August 31, 2022, were invited to participate. The sample size was calculated based on the study by Narita et al. [20], which evaluated the effect of mosapride in laparoscopic colectomy. In that study, the primary outcome—the mean time to the first bowel sound—was 48.5±21.9 hours in the mosapride group and 69.3±23.5 hours in the control group. To achieve 90% power to detect a significant 20% reduction in the median postoperative time to the first bowel sound at a 5% significance level, and accounting for a 15% attrition rate, a final cohort of 23 patients per group was determined.

The inclusion criteria were patients aged 15 to 80 years undergoing elective colorectal surgery, classified as American Society of Anesthesiologists (ASA) physical status I to III. Exclusion criteria included patients who declined participation or withdrew from the study, those with a history of mosapride allergy, pregnant women, patients with ASA physical status IV to V, individuals undergoing emergency colorectal cancer surgery, and patients with intestinal perforation or obstruction. Additionally, specific criteria for potential dropouts were established, including voluntary withdrawal of consent, changes in the surgical plan, accidental bowel injuries during surgery, the requirement for postoperative nothing-by-mouth status, or instances of unstable hemodynamics. A visual representation of the study design and patient flowchart is shown in Fig. 1.

Randomization

Randomization was performed using a computer-generated random numbers table with a fixed block size of 4, ensuring a 1:1 allocation ratio. The allocation sequence was consecutively numbered and concealed in sealed, opaque envelopes, managed by the corresponding author. Upon patient admission, a designated investigator opened the envelope. To minimize selection bias, the investigator who opened the envelopes was not involved in patient care. This method ensured impartial and unbiased allocation to the respective groups.

Study procedure

Both open and laparoscopic colorectal cancer surgical procedures were performed according to the study protocol. The mosapride group received 5 mg of mosapride orally or via a nasogastric tube with 50 mL of water, 3 times daily (total daily dose, 15 mg), beginning on the morning of postoperative day 1 and continuing until hospital discharge or for a maximum of 5 postoperative days. The control group received 5 mg of placebo with 50 mL of water on the same schedule. The hospital pharmacist prepared the placebo capsules to closely resemble the mosapride capsules, ensuring that neither appearance nor taste could differentiate them. Several quality control measures, including regular checks by trained clinical staff, were implemented to ensure proper medication administration. We adhered to standard reporting protocols, as used in other US Food and Drug Administration (FDA)-approved drug trials, to minimize the risk of medication errors. Oral feeding was initiated once the first bowel sound and the first passage of flatus were observed; if tolerated, patients progressed through a full liquid diet, a soft diet, and then a regular diet.

Patients were discharged once the following criteria were met: tolerance of a soft diet without discomfort, return of bowel movements, and a normal body temperature with no major complications. Prophylactic postoperative antiemetics were prohibited to avoid confounding the results or interfering with the effects of other potential prokinetic agents. However, patients who experienced vomiting received ondansetron, which does not possess prokinetic properties.

The primary endpoint was the postoperative time to the first passage of flatus and bowel sound, as assessed by a blinded investigator. The investigator recorded the timing of the first passage of flatus and bowel sound within the first 24 hours after surgery and then at least twice daily until 72 hours postoperatively. “Time to first flatus” was defined as the interval from the completion of surgery (as recorded in the operative note and documented in the electronic medical record) to the patient’s self-report of passing flatus. “Time to first bowel sound” was defined as the interval from the completion of surgery to the physician’s assessment of bowel sound during routine rounds (typically conducted twice daily). Secondary endpoints included the time to transition to a soft diet, the length of postoperative hospital stay, and the occurrence of adverse effects.

Statistical analysis

Statistical analysis was performed using Stata SE ver. 18.0 (Stata Corp) (Standard Edition). Data were summarized using descriptive statistics, including means, standard deviations, medians, and ranges. Analyses followed an intention-to-treat strategy, excluding cases of dropout. A t-test was used to compare the means of 2 independent groups when data were normally distributed; otherwise, the Wilcoxon rank sum test was employed. The chi-square test was used to evaluate differences between categorical variables. A P-value of less than 0.05 was considered statistically significant.

RESULTS

All participants were initially randomized to receive mosapride (23 patients) or a placebo (23 patients). Due to COVID-19 constraints, data collection for the last 2 patients was halted, resulting in a final sample of 44 patients—21 in the mosapride group and 23 in the placebo group (Fig. 1). Baseline characteristics, including age, tumor size, tumor location, operative time, blood loss, and type of surgery, are detailed in Table 1. The median ages were 70 years in the mosapride group and 68 years in the control group. In terms of tumor staging, T3 was most common in both groups. In the mosapride group, 9 patients underwent open colectomy and 12 underwent laparoscopic colectomy; in the control group, 15 underwent open colectomy and 8 underwent laparoscopic colectomy. No statistically significant differences were observed between the groups regarding mean age, tumor characteristics, patient characteristics, tumor location, or type of surgery (all P>0.05).

Three patients dropped out—1 in the control group due to an accidental duodenal tear and 2 in the mosapride group due to delirium and palpitations. Consequently, 41 patients were included in the final analysis: 22 in the control group and 19 in the mosapride group (Fig. 1). The mosapride group demonstrated significantly shorter times to the first bowel sound (26 hours vs. 50 hours, P=0.004) and passage of flatus (40 hours vs. 70 hours, P=0.003). Additionally, the time to transition to a soft diet was shorter in the mosapride group (90 hours vs. 132 hours, P=0.004), as was the time to defecation (80 hours vs. 120 hours, P<0.001). Furthermore, the length of hospital stay was significantly reduced in the mosapride group (7 days vs. 10 days, P=0.004), as detailed in Table 2.

Among patients undergoing laparoscopic colectomy, 20 participants were included, with 12 randomized to receive mosapride and 8 to the placebo group. The mosapride group experienced significantly shorter times to the first bowel sound (24.5 hours vs. 45 hours, P=0.030) and first passage of flatus (34 hours vs. 67 hours, P=0.025). Although the mosapride group also demonstrated shorter times to transition to a soft diet, defecation, and a reduced length of hospital stay, these differences did not reach statistical significance (Supplementary Table 1).

Among patients undergoing open colectomy, 21 participants were enrolled and randomly assigned to receive either mosapride (7 patients) or placebo (14 patients). The mosapride group achieved statistically significant reductions in various postoperative recovery milestones compared to the control group, including the time to the first bowel sound, time to passage of flatus, time to transition to a soft diet, time to defecation, and overall length of hospital stay. Additionally, the mosapride group exhibited a substantial reduction of 31 hours in the time to the first bowel sound and 29 hours in the time to the first passage of flatus compared to the control group. Notably, these patients experienced an average reduction of 4 days in-hospital stay, as detailed in Supplementary Table 2. These findings highlight the significant benefits of mosapride in expediting postoperative recovery and reducing hospitalization duration in open colorectal surgery patients (Fig. 2).

DISCUSSION

Mosapride citrate is a prokinetic drug notable for its high selectivity as an agonist of the 5-HT4 receptor in the digestive tract. It does not affect the dopamine D2 receptor or other receptors, which makes it a common prescription for treating digestive disorders such as chronic gastritis and gastroesophageal reflux disease.

Our investigation examined the effect of mosapride on postoperative gastrointestinal motility following both open and laparoscopic colectomy. The findings revealed a significantly reduced incidence of prolonged postoperative ileus among patients receiving mosapride. As anticipated, the mean time to the first bowel sound was reduced by 24 hours, and the time to passage of flatus was decreased by 30 hours in the mosapride group compared to the control group.

Another noteworthy observation was the significantly shorter hospital stay in the mosapride group, averaging 7 days compared to 10 days in the control group. This finding not only underscores mosapride’s capacity to expedite gastrointestinal recovery but also highlights its potential to reduce the duration of hospitalization.

The study encountered some unanticipated challenges, including the withdrawal of 3 patients—1 due to an accidental duodenal tear in the control group and 2 due to delirium and palpitations in the mosapride group. It is important to note that our sample size was meticulously calculated with potential dropouts in mind. For the patient who experienced palpitations, it is essential to acknowledge that mosapride’s side effects cannot be entirely excluded.

Concerning anastomosis leakage, surgeons typically exercise caution when reintroducing a diet. In our study, however, no cases of anastomosis leakage were observed. Notably, only 1 patient in the control group experienced prolonged POI, as evidenced by symptoms such as nausea, vomiting, inability to tolerate an oral diet, abdominal distension, and delayed passage of flatus and stool on the third postoperative day. This patient’s postoperative stay extended to 35 days, adversely affecting quality of life and increasing in-hospital expenses. Overall, the incidence of prolonged postoperative ileus was lower than anticipated, and no participants required additional laxatives or prokinetic drugs during their hospital stay.

Our findings are consistent with 2 previous randomized controlled trials by Narita et al. [20] and Lohsiriwat [21], which demonstrated that mosapride reduced the mean time to the first bowel movement following hand-assisted laparoscopic colectomy. Mosapride also effectively shortened the duration of POI in open colorectal surgery. Its beneficial impact on serotonin and acetylcholine receptors in the digestive tract likely stimulates motility in both the upper and lower gastrointestinal tracts and enhances gastric emptying, thereby facilitating a faster return to normal bowel function without significant side effects.

This study has 2 significant strengths. First, the triple-blind design enhanced the reliability of the results, as all patients were evaluated by a single investigator who was unaware of each patient’s treatment assignment. Second, the surgeries were performed by a team of 6 surgeons, supporting the generalizability of our findings across various surgical practitioners. Additionally, our study included patients with colorectal cancer undergoing both laparoscopic and open colectomy procedures, unlike many other studies that focused on a single surgical approach.

Despite these strengths, several limitations should be acknowledged. The data collection period was relatively short, and the sample size was limited due to the COVID-19 pandemic. Larger multicenter studies are needed to validate these findings. Furthermore, the time to first flatus was based on patient self-reports, whereas the time to first bowel movement was assessed by physicians during routine rounds (typically conducted twice daily). Although the evaluation of the first bowel movement was somewhat subjective, using a single investigator helped ensure consistency.

We propose that a multicenter study be undertaken, recruiting patients after their postoperative surgery. Currently, most surgeons use the return of bowel movement as the criterion for resuming a regular diet, although this approach may not be uniformly applied. Consequently, it would be valuable to investigate whether preoperative administration of mosapride could further expedite postoperative gastrointestinal recovery.

In conclusion, this study established the effectiveness of mosapride in patients undergoing elective colorectal surgery. Its administration resulted in substantial improvements in gastrointestinal motility recovery and a notable reduction in the length of hospital stays, all without any serious adverse effects.

ARTICLE INFORMATION

Conflict of interest

No potential conflict of interest relevant to this article was reported.

Funding

None.

Author contributions

Conceptualization: all authors; Data curation: TT, BS, CS, PP, NP, PC; Formal analysis: TT, BS, CS, VP, NP, PC; Investigation: TT, BS, PC; Methodology: TT, BS, CS, VP, NP, PC; Project administration: TT, BS, CS, CW, PC; Visualization: TT, BS, CS, VP, CW, JJ, PP, NP, PC; Writing–original draft: TT, BS, NP; Writing–review & editing: CS, CW, JJ, PP, VP, PS. All authors read and approved the final manuscript.

Additional information

This study was presented at the 31st United European Gastroenterology Week 2023 on October 2023 in Copenhagen, Denmark.

SUPPLEMENTARY MATERIALS

Supplementary Table 1.

Outcomes in laparoscopic colorectal surgery (n=20)

ac-2024-00892-0127-Supplementary-Table-1.pdf

Supplementary Table 2.

Outcomes in open colorectal surgery (n=21)

ac-2024-00892-0127-Supplementary-Table-2.pdf

Supplementary materials are available from https://doi.org/10.3393/ac.2024.00892.0127.

Fig. 1.

Randomization of the patients.

Fig. 2.

Outcome variables. Values are presented as median (range).

Table 1.

Demographic characteristics of the patients according to the study group (n=44)

Characteristic	Mosapride group (n=21)	Control group (n=23)	P-value
Sex			0.547
Male	12 (57.1)	10 (43.5)
Female	9 (42.9)	13 (56.5)
Age (yr)	70 (67–77)	68 (62–71)	0.147
Underlying disease
Diabetes	4 (19.1)	7 (30.4)	0.384
Hypertension	10 (47.6)	13 (56.5)	0.555
Dyslipidemia	5 (23.8)	8 (34.8)	0.518
Chronic kidney disease	1 (4.76)	0 (0)	0.477
Cerebrovascular disease	1 (4.8)	0 (0)	0.477
Ischemic heart disease	0 (0)	2 (8.7)	0.489
Tumor size (cm)	4.5 (3.5–5.5)	4 (1.5–5.5)	0.334
T category			0.153
T1	3 (14.3)	1 (4.3)
T2	1 (4.8)	5 (21.7)
T3	16 (76.2)	13 (56.5)
T4	1 (4.8)	4 (17.4)
N category			0.526
N0	9 (42.9)	13 (56.5)
N1	8 (38.1)	5 (21.7)
N2	4 (19.0)	5 (21.7)
M category (M1)	3 (14.3)	2 (8.7)	0.658
Tumor location			0.435
Ascending colon	5 (23.8)	5 (21.7)
Transverse colon	1 (4.8)	3 (13.0)
Descending colon	0 (0)	2 (8.7)
Sigmoid colon	10 (47.6)	6 (26.1)
Rectum	5 (23.8)	7 (30.4)
Type of operation			0.455
Right hemicolectomy	4 (19.0)	7 (30.4)
Left hemicolectomy	1 (4.8)	1 (4.3)
Sigmoidectomy	5 (23.8)	3 (13.0)
Anterior resection	10 (47.6)	7 (30.4)
Abdominoperineal resection	0 (0)	3 (13.0)
Subtotal colectomy	1 (4.8)	2 (8.7)
Blood loss (mL)	100 (50–200)	150 (60–350)	0.056
Operation time (min)	208.2±94.2	207.6±74.4	0.975
Type of procedure			0.137
Laparoscopy	12 (57.1)	8 (34.8)
Open	9 (42.9)	15 (65.2)

Values are presented as number (%), median (range), or mean±standard deviation.

Table 2.

Surgical outcome (n=41)

Outcome	Mosapride group (n=19)	Control group (n=22)	P-value
Time to first bowel sound (hr)	26 (20–40)	50 (40–65)	0.004^*
Time to first passage flatus (hr)	40 (26–52)	70 (60–91)	0.003^*
Time to defecate (hr)	80 (70–100)	120 (98–138)	<0.001^*
Time to soft diet (hr)	90 (67–104)	132 (112–160)	0.004^*
Length of stay (day)	7 (6–9)	10 (8–10)	0.004^*

Values are presented as median (range).

^*P<0.05.

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2. Luckey A, Livingston E, Taché Y. Mechanisms and treatment of postoperative ileus. Arch Surg 2003;138:206–14. Article PubMed
3. Vather R, O'Grady G, Bissett IP, Dinning PG. Postoperative ileus: mechanisms and future directions for research. Clin Exp Pharmacol Physiol 2014;41:358–70. Article PubMed
4. Goldstein JL, Matuszewski KA, Delaney CP, Senagore A, Chiao EF, Shah M, et al. Inpatient economic burden of postoperative ileus associated with abdominal surgery in the United States. P T 2007;32:82–90.
5. Venara A, Neunlist M, Slim K, Barbieux J, Colas PA, Hamy A, et al. Postoperative ileus: pathophysiology, incidence, and prevention. J Visc Surg 2016;153:439–46. Article PubMed
6. Gerring EE, Hunt JM. Pathophysiology of equine postoperative ileus: effect of adrenergic blockade, parasympathetic stimulation and metoclopramide in an experimental model. Equine Vet J 1986;18:249–55. Article PubMed
7. Stakenborg N, Gomez-Pinilla PJ, Boeckxstaens GE. Postoperative Ileus: pathophysiology, current therapeutic approaches. Handb Exp Pharmacol 2017;239:39–57. Article PubMed
8. Schwenk W, Böhm B, Haase O, Junghans T, Müller JM. Laparoscopic versus conventional colorectal resection: a prospective randomised study of postoperative ileus and early postoperative feeding. Langenbecks Arch Surg 1998;383:49–55. Article PubMed PDF
9. Chapman SJ, Thorpe G, Vallance AE, Harji DP, Lee MJ, Fearnhead NS, et al. Systematic review of definitions and outcome measures for return of bowel function after gastrointestinal surgery. BJS Open 2018;3:1–10. Article PubMed PMC PDF
10. Bungard TJ, Kale-Pradhan PB. Prokinetic agents for the treatment of postoperative ileus in adults: a review of the literature. Pharmacotherapy 1999;19:416–23. Article PubMed
11. Georgiadis GT, Markantonis-Kyroudis S, Triantafillidis JK. Prokinetic agents: current aspects with focus on cisapride. Ann Gastroenterol 2000;13:269–89.
12. Reynolds JC, Putnam PE. Prokinetic agents. Gastroenterol Clin North Am 1992;21:567–96. Article PubMed
13. Taniyama K, Makimoto N, Furuichi A, Sakurai-Yamashita Y, Nagase Y, Kaibara M, et al. Functions of peripheral 5-hydroxytryptamine receptors, especially 5-hydroxytryptamine4 receptor, in gastrointestinal motility. J Gastroenterol 2000;35:575–82. Article PubMed PDF
14. Okamura K, Sasaki N, Yamada M, Yamada H, Inokuma H. Effects of mosapride citrate, metoclopramide hydrochloride, lidocaine hydrochloride, and cisapride citrate on equine gastric emptying, small intestinal and caecal motility. Res Vet Sci 2009;86:302–8. Article PubMed
15. Gong J, Xie Z, Zhang T, Gu L, Yao W, Guo Z, et al. Randomised clinical trial: prucalopride, a colonic pro-motility agent, reduces the duration of post-operative ileus after elective gastrointestinal surgery. Aliment Pharmacol Ther 2016;43:778–89. Article PubMed
16. Curran MP, Robinson DM. Mosapride in gastrointestinal disorders. Drugs 2008;68:981–91. Article PubMed
17. Miyoshi A, Miwa T, Harasawa S, Yoshida Y, Masamune O, Kmura K, et al. Dose-finding study of AS-4370 (mosapride citrate) in patients with chronic gastritis. Rinsho Iyaku 1998;14:1069–90. Japanese.
18. Hallerbäck BI, Bommelaer G, Bredberg E, Campbell M, Hellblom M, Lauritsen K, et al. Dose finding study of mosapride in functional dyspepsia: a placebo-controlled, randomized study. Aliment Pharmacol Ther 2002;16:959–67. Article PubMed PDF
19. Toyomasu Y, Mochiki E, Morita H, Ogawa A, Yanai M, Ohno T, et al. Mosapride citrate improves postoperative ileus of patients with colectomy. J Gastrointest Surg 2011;15:1361–7. Article PubMed PDF
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The efficacy of mosapride on recovery of intestinal motility after elective colorectal cancer surgery: a randomized controlled trial

Ann Coloproctol. 2025;41(3):232-238. Published online June 25, 2025

DOI: https://doi.org/10.3393/ac.2024.00892.0127

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The efficacy of mosapride on recovery of intestinal motility after elective colorectal cancer surgery: a randomized controlled trial

Fig. 1. Randomization of the patients.

Fig. 2. Outcome variables. Values are presented as median (range).

Fig. 1.

Fig. 2.

The efficacy of mosapride on recovery of intestinal motility after elective colorectal cancer surgery: a randomized controlled trial

Characteristic	Mosapride group (n=21)	Control group (n=23)	P-value
Sex			0.547
Male	12 (57.1)	10 (43.5)
Female	9 (42.9)	13 (56.5)
Age (yr)	70 (67–77)	68 (62–71)	0.147
Underlying disease
Diabetes	4 (19.1)	7 (30.4)	0.384
Hypertension	10 (47.6)	13 (56.5)	0.555
Dyslipidemia	5 (23.8)	8 (34.8)	0.518
Chronic kidney disease	1 (4.76)	0 (0)	0.477
Cerebrovascular disease	1 (4.8)	0 (0)	0.477
Ischemic heart disease	0 (0)	2 (8.7)	0.489
Tumor size (cm)	4.5 (3.5–5.5)	4 (1.5–5.5)	0.334
T category			0.153
T1	3 (14.3)	1 (4.3)
T2	1 (4.8)	5 (21.7)
T3	16 (76.2)	13 (56.5)
T4	1 (4.8)	4 (17.4)
N category			0.526
N0	9 (42.9)	13 (56.5)
N1	8 (38.1)	5 (21.7)
N2	4 (19.0)	5 (21.7)
M category (M1)	3 (14.3)	2 (8.7)	0.658
Tumor location			0.435
Ascending colon	5 (23.8)	5 (21.7)
Transverse colon	1 (4.8)	3 (13.0)
Descending colon	0 (0)	2 (8.7)
Sigmoid colon	10 (47.6)	6 (26.1)
Rectum	5 (23.8)	7 (30.4)
Type of operation			0.455
Right hemicolectomy	4 (19.0)	7 (30.4)
Left hemicolectomy	1 (4.8)	1 (4.3)
Sigmoidectomy	5 (23.8)	3 (13.0)
Anterior resection	10 (47.6)	7 (30.4)
Abdominoperineal resection	0 (0)	3 (13.0)
Subtotal colectomy	1 (4.8)	2 (8.7)
Blood loss (mL)	100 (50–200)	150 (60–350)	0.056
Operation time (min)	208.2±94.2	207.6±74.4	0.975
Type of procedure			0.137
Laparoscopy	12 (57.1)	8 (34.8)
Open	9 (42.9)	15 (65.2)

Outcome	Mosapride group (n=19)	Control group (n=22)	P-value
Time to first bowel sound (hr)	26 (20–40)	50 (40–65)	0.004^*
Time to first passage flatus (hr)	40 (26–52)	70 (60–91)	0.003^*
Time to defecate (hr)	80 (70–100)	120 (98–138)	<0.001^*
Time to soft diet (hr)	90 (67–104)	132 (112–160)	0.004^*
Length of stay (day)	7 (6–9)	10 (8–10)	0.004^*

Table 1. Demographic characteristics of the patients according to the study group (n=44)

Values are presented as number (%), median (range), or mean±standard deviation.

Table 2. Surgical outcome (n=41)

Values are presented as median (range).

P<0.05.