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Original Article
Anorectal benign disease
 Lower pain, less itching, and faster healing after ultrasound scalpel-assisted hemorrhoidectomy using an intimate cleaner containing chlorhexidine, acid hyaluronic acid, and natural anti-inflammatories: a multicenter observational case-control study
Antonio Brillantino1,*orcid, Luigi Marano2,*orcid, Maurizio Grillo1orcid, Alessio Palumbo1orcid, Fabrizio Foroni1orcid, Luciano Vicenzo1orcid, Alessio Antropoli3orcid, Michele Lanza1orcid, Maria Laura Sandoval Sotelo1orcid, Nicola Sangiuliano1orcid, Mauro Maglio1orcid, Rosanna Filosa4,5orcid, Lucia Abbatiello4orcid, Maria Preziosa Romano4orcid, Luana Passariello6orcid, Pasquale Talento7orcid, Giovanna Ioia8orcid, Corrado Rispoli9orcid, Mariano Fortunato Armellino10orcid, Vincenzo Bottino11orcid, Adolfo Renzi12orcid, Carlo Bartone13orcid, Luigi Monaco14orcid, Paolino Mauro1orcid, Stefano Picardi1orcid, Maria Paola Menna1orcid, Elisa Palladino1orcid, Mario Massimo Mensorio15orcid, Vinicio Mosca16,17orcid, Claudio Gambardella17orcid, Luigi Brusciano17orcid, Ludovico Docimo17orcid
Annals of Coloproctology 2024;40(6):602-609.
DOI: https://doi.org/10.3393/ac.2024.00570.0081
Published online: December 30, 2024

1Department of General Surgery, Antonio Cardarelli Hospital, Naples, Italy

2Department of Medicine, Academy of Applied Medical and Social Sciences (Akademia Medycznych i Społecznych Nauk Stosowanych, AMiSNS), Elbląg, Poland

3IRCCS San Raffaele Scientific Institute, Milan, Italy

4Department of Science and Technology, University del Sannio, Benevento, Italy

5Cardiac Rehabilitation Unit of Telese Terme Institute, Istituti Clinici Scientifici Maugeri IRCCS, Telese Terme, Italy

6Unit of Clinical and Molecular Pathology, University of Campania Luigi Vanvitelli, Naples, Italy

7Department of Surgery, Pelvic Floor Center, AUSL-IRCCS di Reggio Emilia, Reggio Emilia, Italy

8Department of General and Oncologic Surgery, Andrea Tortora Hospital, ASL Salerno, Pagani, Italy

9Unit of General Surgery, AORN dei Colli, Monaldi Hospital, Naples, Italy

10Department of Surgery, Del Mare Hospital, ASL Napoli 1, Naples, Italy

11Unit of Surgery, Betania Evangelical Hospital, Naples, Italy

12Department of Surgery, Buonconsiglio Farebenefratelli Hospital, Naples, Italy

13Department of Surgery, School of Medicine, University of Naples Federico II, Naples, Italy

14Unit of Surgery, Villa Hester Clinic, Avellino, Italy

15Department of Health, Antonio Cardarelli Hospital, Naples, Italy

16Unit of General Surgery, G. Moscati Hospital, Aversa, Italy

17Department of Advanced Medical and Surgical Sciences, University of Campania Luigi Vanvitelli, Naples, Italy

Correspondence to: Luigi Marano MD, PhD Department of Medicine, Academy of Applied Medical and Social Sciences (Akademia Medycznych i Społecznych Nauk Stosowanych, AMiSNS), Lotnicza 2, Elbląg 82-300, Poland Email: l.marano@amisns.edu.pl
*Antonio Brillantino and Luigi Marano contributed equally to this study as co-first authors.
• Received: August 25, 2024   • Revised: October 28, 2024   • Accepted: October 31, 2024

© 2024 The Korean Society of Coloproctology

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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  • Purpose
    Postoperative pain is a major concern for patients undergoing ultrasound scalpel-assisted hemorrhoidectomy, potentially exacerbated by delayed wound healing. This study aimed to evaluate the impact of an intimate cleansing gel containing chlorhexidine, hyaluronic acid, and other anti-inflammatory agents (Antroclean Fisioderm) on postoperative pain, itching, and wound healing in patients who had undergone this procedure.
  • Methods
    This multicenter observational case-control study involved a cohort of consecutive adult patients who underwent hemorrhoidectomy using an ultrasound device. The study compared 2 different postoperative wound management strategies over 1 month after surgery: washing with warm water twice per day (control group) versus a 2-minute topical application of intimate cleansing gel (Antroclean Fisioderm) followed by a warm water wash (intervention group).
  • Results
    The median postoperative pain score was significantly lower in the intervention group than in the control group at each follow-up point (P<0.01). The percentage of patients reporting anal itching was also significantly lower in the intervention group than in the control group at each follow-up point (P<0.01). All patients in the intervention group achieved complete wound healing 4 weeks after surgery, compared to 88 (82%) in the control group (P<0.01). No adverse events were reported.
  • Conclusion
    The topical application of intimate cleansing gel (Antroclean Fisioderm) twice daily for 1 month following ultrasound scalpel-assisted hemorrhoidectomy appears to be associated with faster healing, reduced pain, decreased itching, and improved quality of life, without any adverse effects. Further larger and prospective randomized trials are recommended to confirm these findings.
  • Keywords: Hemorrhoids; Hemorrhoidectomy; Cleansing agents; Wound healing; Pruritus ani
Open hemorrhoidectomy remains a valuable treatment option for patients with high-grade internal hemorrhoidal prolapse (grades 3 and 4 according to the Goligher classification), for those with both high-grade prolapse and external pathological hemorrhoids, and for patients experiencing recurrent symptoms and prolapse following non-excisional procedures [1–4]. However, conventional hemorrhoidectomy is associated with a range of complications. Notably, it can lead to early postoperative pain, which tends to be both more severe and more frequent than the pain associated with nonexcisional procedures [5–8]. Postoperative pain is a significant concern for patients and can result from several factors: sensitivity in the anoderm, incisions in the internal anal sphincter, edema in mucocutaneous bridges, spasms in the internal sphincter, and persistent open wounds in the perianal region [9–11]. Delayed wound healing after hemorrhoidectomy can exacerbate postoperative anal pain and itching, increase patient discomfort, delay the return to normal activities, and worsen quality of life [9–11].
To mitigate postoperative pain, nonexcisional surgical strategies have been proposed as alternative treatments for hemorrhoidal disease. These include stapled prolassectomy, transanal hemorrhoidal dearterialization, and laser hemorrhoidoplasty [12–15]. However, these procedures often exhibit poorer long-term outcomes compared to hemorrhoidectomy, particularly in patients with high-grade hemorrhoidal prolapse or those with both high-grade prolapse and external pathological hemorrhoids [12–15]. Recently, the topical application of a gel containing dimethicone and cyclopentasiloxane in patients undergoing hemorrhoidectomy was associated with improved pain control and wound healing compared to standard care [16].
However, to our knowledge, no study has yet evaluated the impact of an intimate cleaner on postoperative pain and healing following a hemorrhoidectomy. In this study, we aimed to evaluate the impact of an intimate cleansing gel formulated with chlorhexidine, hyaluronic acid, evening primrose (Oenothera biennis) oil, and other anti-inflammatory, soothing, and refreshing agents on the short-term outcomes of ultrasound scalpel-assisted hemorrhoidectomy (USAH). Our focus was on assessing postoperative pain, pruritus, and wound healing in patients.
Ethics statement
The study protocol was approved by the Institutional Board of the Italian Unitary Society of Colon-Proctology (No. 0002/2023). Prior to surgery, all patients provided informed written consent for their participation in the study, the surgical intervention, and the collection, processing, storage, and use of their personal data for scientific research purposes. This study, which involved human participants, was conducted in accordance with the ethical and humane principles of research as outlined in the 1975 Declaration of Helsinki. The study adhered to the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) statement guidelines for reporting observational studies [17].
Study design
The research involved a multicenter observational case-control study that analyzed data from a 1-year cohort of consecutive adult patients undergoing USAH to treat high-grade hemorrhoidal prolapse. This study was conducted at 10 European centers: Antonio Cardarelli Hospital (Naples, Italy), Academy of Applied Medical and Social Sciences (Elbląg, Poland), Pelvic Floor Center, AUSL-IRCCS di Reggio Emilia (Reggio Emilia, Italy), Andrea Tortora Hospital, ASL Salerno (Pagani, Italy), Unit of General Surgery, AORN dei Colli, Monaldi Hospital (Naples, Italy), Del Mare Hospital, ASL Napoli 1 (Naples, Italy), Betania Evangelical Hospital (Naples, Italy), Buonconsiglio Farebenefratelli Hospital (Naples, Italy), Villa Hester Clinic (Avellino, Italy), and University of Campania Luigi Vanvitelli (Naples, Italy).
Patient selection
From January to December 2023, all patients scheduled for surgical treatment of hemorrhoidal disease at the included centers were entered into a prospective database and assessed for eligibility. This study included patients aged between 16 and 75 years with Goligher grade III or IV hemorrhoidal prolapse who were scheduled for conventional Milligan-Morgan hemorrhoidectomy. Conversely, patients with Goligher grade II prolapse, those who were pregnant, had cancer, were immunodepressed, had undergone previous hemorrhoidectomy, or had acutely thrombosed or strangulated hemorrhoids, as well as those scheduled for nonexcisional procedures, were excluded.
Preoperative evaluation
All subjects underwent a preoperative assessment that included a physical examination and anamnesis, with a particular focus on bowel function, pregnancies, episiotomy, previous surgeries, and associated diseases. The severity of hemorrhoidal symptoms and the patients' health-related quality of life were evaluated using the Rørvik score 2 weeks before surgery. Rørvik scoring system consists of the Short Health Scale adapted for hemorrhoidal disease and the Hemorrhoidal Disease Symptom Score (HDSS) [18]. For the purpose of this study, only HDSS was used to grade the patients' symptoms. The HDSS assesses 5 different parameters of hemorrhoidal disease: anal pain, itching, soiling, bleeding, and prolapsing hemorrhoids. Each parameter is graded on a scale from 0 (no symptoms) to 4 (daily presence of symptoms). The total score from all 5 parameters was used to evaluate the patient’s condition, where 0 indicated no symptoms and 20 represented the most severe clinical scenario.
All patients were referred to surgery following at least 6 months of unsuccessful medical treatment, which included a high-fiber diet and bioflavonoids. Prior to surgery, a pancolonscopy was conducted to rule out any neoplasms or inflammatory bowel disease.
Surgery
All patients underwent a hemorrhoidectomy using the same surgical technique. Initially, after administering spinal anesthesia, patients were positioned in the lithotomy position, and prophylactic antibiotics were given using ceftriaxone (2 g intravenous). Hemorrhoidectomy was carried out using an ultrasound device (Focus Ultracision-Harmonic Scalpel, Ethicon Endo-Surgery). The procedure began with an incision of the anodermal wedge, during which any external fibrosis and/or skin tags were removed if present. Dissection then proceeded upward, involving en bloc excision of the mucosal and submucosal layers from the underlying internal anal sphincter up to the anorectal ring. A compressive hemostatic sponge was placed and left in situ for 12 to 24 hours. Postoperatively, a 24-hour elastomeric continuous intravenous analgesic infusion was administered, consisting of ketorolac (30 mg/1 mL), tramadol (100 mg/2 mL), and ranitidine (300 mg).
Postoperative care
Standard postoperative care for all patients included dietary modifications such as stool softeners and fiber supplements, accompanied by adequate fluid intake. Additionally, oral analgesia was provided with 10 mg of ketorolac tromethamine every 6 hours as needed, with a maximum dosage of 60 mg per day for 3 consecutive days. Pain was then controlled using ketorolac or paracetamol as needed.
The study was divided into 2 periods based on the management of postoperative anal wounds. In the first period, spanning 6 months from January to June 2023, wounds were treated solely with warm water washes twice daily (control group). In the subsequent 6-month period, from July to December 2023, the treatment regimen consisted of daily warm water washes preceded by a 2-minute topical application of intimate cleansing gel (Antroclean Fisioderm, Dermofarma Italia) for 30 consecutive days (intervention group). Table 1 displays the chemical composition of Antroclean Fisioderm.
Follow-up
After discharge, follow-up appointments were scheduled for postoperative week 1, 2, 3, and 4. These included a physical examination to evaluate wound healing (categorized as complete or incomplete), assessment of anal pain and itching using a 10-point visual analogue scale (VAS), evaluation of analgesic use, and estimation of health-related quality of life using the Rørvik score at the 4-week follow-up.
Study outcomes
The primary outcomes of the study included the prevalence and severity of postoperative anal pain and itching at each follow-up point, as well as the prevalence of complete wound healing at the final follow-up point, which occurred 4 weeks after surgery. The secondary outcome encompassed patient satisfaction and quality of life, as measured by the Rørvik score at the final follow-up.
Statistical analysis
Statistical analysis was conducted using Microsoft Excel 2021 (Microsoft Corp). Categorical data were presented as raw numbers with percentages in parentheses. Continuous data were expressed as mean±standard deviation or as median (range), depending on the distribution. Differences between results were analyzed using the unpaired t-test, the Mann-Whitney U-test, or the Fisher exact test, as appropriate. A probability value of less than 0.05 was considered significant.
Study population
During the research period, 238 patients met the selection criteria, underwent surgical treatment, and were considered for enrollment in this study. Of these, 15 (6.3%) were lost to follow-up, while 223 (124 men and 99 women; median age, 51 years [range, 19–72 years]) attended all follow-up visits, forming the final study population.
Of those participants, 107 (48.0%) were enrolled during the first study period and included in the control group, while 116 (52.0%) underwent surgery during the second study period and were included in the intervention group.
Table 2 presents the primary characteristics of the 2 groups. There were no statistically significant differences between the groups in terms of median age, sex ratio, American Society of Anesthesiologists (ASA) physical status, prevalence of comorbidities, Rørvik score, and Goligher prolapse grade.
Overall, among all the patients included in the study, the most common preoperative symptom was bleeding, observed in 199 patients (89.2%). Other reported symptoms included constipation in 153 patients (68.6%), soiling in 45 (20.2%), and anal pain in 42 (18.8%). The most frequently recorded comorbidity was hypertension, affecting 69 patients (30.9%), followed by diabetes mellitus in 34 (15.2%), other cardiovascular diseases in 9 (4.0%), chronic obstructive pulmonary disease in 7 (3.1%), and neurologic diseases in 3 (1.3%).
Surgery
The mean operative time was 23±3 minutes for the control group and 24±2 minutes for the intervention group (unpaired t-test, P=0.08). The median duration of hospitalization was 1 day for both groups (control group: range, 1–3 days; intervention group: range, 1–2 days; Mann-Whitney U-test, P>0.99). There were no significant intraoperative complications in either group. Two patients in the control group and 1 patient in the intervention group underwent reoperation on the first postoperative day due to spontaneous bleeding. Twelve patients (5.3%), with 6 from each group, experienced urinary retention.
Primary outcomes
The median postoperative pain score, assessed using VAS, was significantly lower in the intervention group compared to the control group at each follow-up point (P=0.02) (Fig. 1).
The severity of anal itching, as measured by the median VAS, was significantly lower in the intervention group compared to the control group throughout the entire follow-up period (P<0.01), except for the third follow-up point (4 weeks after surgery, P=0.05) (Fig. 2).
The percentage of patients who used analgesics after discharge was lower in the intervention group at each follow-up point. Statistical significance was achieved 1 week after surgery and was maintained throughout the entire follow-up period. The percentage of patients who reported anal itching was significantly lower in the intervention group than in the control group at each follow-up visit. In the intervention group, all patients achieved complete wound healing by the last follow-up, compared to 88 patients (82.2%) in the control group (P<0.01) (Table 3). No patients in either group experienced postoperative local infections. All patients in the intervention group reported a refreshing local sensation following the topical application of Antroclean Fisioderm. No burning sensations or adverse events related to this treatment were recorded.
Secondary outcome
The Rørvik score at the 1-month follow-up point was 4.7±1.7 in the intervention group and 6.1±1.8 in the control group (P=0.04).
The findings of the current study suggest that the topical application of intimate cleansing gel (Antroclean Fisioderm) may play a role in alleviating postoperative pain, itching, and improving wound healing in patients undergoing USAH. Additionally, no adverse events associated with the topical administration of the drug were reported.
The observed results can likely be attributed to the chemical composition of the cleaner. Nonetheless, the study's results are constrained by the relatively small sample size and the absence of randomization in treatment allocation. Nevertheless, these findings could provide a basis for a well-conducted randomized controlled trial that compares patients who do or do not receive topical application of intimate cleansing gel (Antroclean Fisioderm) following USAH. Postoperative pain is a major concern for patients undergoing excisional hemorrhoidectomy. While nonexcisional surgical strategies, such as stapled prolassectomy, transanal hemorrhoidal dearterialization, and laser hemorrhoidoplasty, have been proposed as alternatives to treat hemorrhoidal disease and reduce postoperative pain [19–26], excisional surgery remains the recommended approach in specific cases. These include high-grade hemorrhoidal prolapse, combined high-grade prolapse with external pathological hemorrhoids, and recurrent symptoms and prolapse following non-excisional procedures [1].
In the context of excisional surgery, the use of harmonic scalpels or radiofrequency devices has been linked to shorter operative times, reduced intraoperative blood loss, and decreased postoperative pain compared to conventional surgery [27]. However, the persistence of open wounds with delayed healing after hemorrhoidectomy can exacerbate and prolong postoperative pain, increasing patient discomfort and diminishing their quality of life. For patients undergoing hemorrhoidectomy, the traditional wound care regimen, which includes warm water washes, may not sufficiently alleviate symptoms related to wound healing, such as pain and itching, which significantly affect quality of life during the recovery period. In our practice, we observed a consistent pattern of patients experiencing prolonged discomfort and suboptimal healing with the existing regimen. Consequently, we decided to enhance traditional wound care by incorporating a cleansing gel with theoretically beneficial properties. The selection of Antroclean Fisioderm was informed by the known effects of its components: chlorhexidine is recognized for its established antiseptic properties [28], and hyaluronic acid is valued for its role in tissue hydration and healing [29]. Additionally, other ingredients like evening primrose oil and Centella asiatica (gotu kola), known for their anti-inflammatory and skin-repair properties, led us to hypothesize that they could improve wound care outcomes [30].
According to our results, using an intimate cleaner such as Antroclean Fisioderm, which possesses healing, refreshing, antibacterial, and anti-inflammatory properties, may accelerate the healing process of open wounds. Consequently, this could reduce postoperative pain and itching, improve quality of life, and enhance the tolerability of surgery.
Considering both the promising results in terms of symptom relief and healing, as well as the high safety profile of the product, it can be inferred that intimate cleaning gel (Antroclean Fisioderm) may play a significant role in managing patients undergoing excisional surgery for hemorrhoidal disease. However, a limitation of this study is the absence of an assessment of analgesic use in both groups. The type and dosage of analgesics could significantly influence reported pain levels and overall patient comfort during the postoperative period. To address this issue, future studies should include a detailed analysis of analgesic use to gain a more comprehensive understanding of pain management and its impact on patient outcomes. Additionally, studies with larger sample sizes and randomized patient groups are necessary to validate our findings and accurately determine the role of this cleansing gel in patients undergoing hemorrhoidectomy.
In conclusion, topical application of intimate cleaning gel (Antroclean Fisioderm) twice daily for 1 month following open hemorrhoidectomy appears to be associated with accelerated healing, reduced pain, decreased itching, and enhanced quality of life, without any adverse effects. Further studies, including larger and prospective-randomized trials, are recommended to confirm these findings.

Conflict of interest

Antonio Brillantino, Luigi Marano, and Pasquale Talento are Editorial Board members of Annals of Coloproctology, but was not involved in the peer reviewer selection, evaluation, or decision process of this article. No other potential conflict of interest relevant to this article was reported.

Funding

None.

Author contributions

Conceptualization: AB, L Marano, MG, AP; Data curation: MFA, FF, LV, AA, ML, MLSS, NS, L Monaco, MM RF, LA, MPR, LP, PT, VM; Formal analysis: AB, L Marano, GI, CR, AA, VB, AR, CB, L Monaco, PM, SP, MPM, EP, VM, MMM; Methodology: AB, L Marano, MG, AP; Supervision: AB, CG, LB, L Marano, LD; Writing–original draft: all authors; Writing–review & editing: all authors. All authors read and approved the final manuscript.

Fig. 1.
Comparison of visual analogue scale (VAS) scores for pain between the control and intervention groups over 4 weeks.
ac-2024-00570-0081f1.jpg
Fig. 2.
Comparison of visual analogue scale (VAS) scores for itching between the control and intervention groups over 4 weeks.
ac-2024-00570-0081f2.jpg
Table 1.
Composition of Antroclean Fisioderm Intimate Cleaner (Dermofarma Italia)
Component %
Hydrogen peroxide (H2O2) 76.5
Setacin 15.0
Hamamelis virginiana water 2.0
Chamomilla water 2.0
Chlorhexidine digluconate 20% 1.5
Centella asiatica (gotu kola) 0.5
Propolis extract 0.5
Oenothera biennis oil 0.5
Isocide 0.3
Xanthan gum 0.3
Kemipur 0.2
Thime oil 0.2
Lemon oil 0.1
Eucalyptus oil 0.1
Citric acid 0.1
Sodium hyaluronate 0.1
Mentol 0.1
Covafresh 0.03

Percentages may not total 100 due to rounding.

Table 2.
Patients’ baseline demographics and characteristics (n=223)
Characteristic Control group (n=107) Intervention group (n=116) P-value
Age (yr) 50 (19–72) 51 (19–70)
Sex >0.99
 Female 60 (56.1) 64 (55.2)
 Male 47 (43.9) 52 (44.8)
ASA physical status
 I 57 (53.3) 63 (54.3) >0.99
 II 38 (35.5) 39 (33.6) >0.99
 III 12 (11.2) 14 (12.1) >0.99
Comorbidity
 Hypertension 34 (31.8) 35 (30.2) >0.99
 Diabetes mellitus 16 (15.0) 18 (15.5) >0.99
 Cardiovascular disease 4 (3.7) 5 (4.3) >0.99
 COPD 3 (2.8) 4 (3.4) >0.99
 Neurologic disease 3 (2.8) 0 (0) 0.10
Preoperative Rørvik score 29.8±6.8 30.1±7.2 0.77
Goligher prolapse classification
 Grade III 44 (41.1) 46 (39.7) >0.99
 Grade IV 63 (59.0) 70 (60.3) >0.99

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

ASA, American Society of Anesthesiologists; COPD, chronic obstructive pulmonary disease.

Table 3.
Primary outcome parameters (n=223)
Parameter No. of patients (%) P-value
Control group (n=107) Intervention group (n=116)
Patients receiving analgesics
 Week 1 53 (49.5) 42 (36.2) 0.05
 Week 2 45 (42.1) 26 (22.4) <0.01
 Week 3 22 (20.6) 7 (6.0) <0.01
 Week 4 7 (6.5) 0 (0) <0.01
Patients with anal itching
 Week 1 46 (43.0) 26 (22.4) <0.01
 Week 2 26 (24.3) 15 (12.9) 0.03
 Week 3 30 (28.0) 7 (6.0) <0.01
 Week 4 15 (14.0) 0 (0) <0.01
Patients with complete healing 88 (82.2) 116 (100) <0.01
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        Lower pain, less itching, and faster healing after ultrasound scalpel-assisted hemorrhoidectomy using an intimate cleaner containing chlorhexidine, acid hyaluronic acid, and natural anti-inflammatories: a multicenter observational case-control study
        Ann Coloproctol. 2024;40(6):602-609.   Published online December 30, 2024
        DOI: https://doi.org/10.3393/ac.2024.00570.0081
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      Lower pain, less itching, and faster healing after ultrasound scalpel-assisted hemorrhoidectomy using an intimate cleaner containing chlorhexidine, acid hyaluronic acid, and natural anti-inflammatories: a multicenter observational case-control study
      Image Image
      Fig. 1. Comparison of visual analogue scale (VAS) scores for pain between the control and intervention groups over 4 weeks.
      Fig. 2. Comparison of visual analogue scale (VAS) scores for itching between the control and intervention groups over 4 weeks.

      Fig. 1.

      Fig. 2.

      Lower pain, less itching, and faster healing after ultrasound scalpel-assisted hemorrhoidectomy using an intimate cleaner containing chlorhexidine, acid hyaluronic acid, and natural anti-inflammatories: a multicenter observational case-control study
      Component %
      Hydrogen peroxide (H2O2) 76.5
      Setacin 15.0
      Hamamelis virginiana water 2.0
      Chamomilla water 2.0
      Chlorhexidine digluconate 20% 1.5
      Centella asiatica (gotu kola) 0.5
      Propolis extract 0.5
      Oenothera biennis oil 0.5
      Isocide 0.3
      Xanthan gum 0.3
      Kemipur 0.2
      Thime oil 0.2
      Lemon oil 0.1
      Eucalyptus oil 0.1
      Citric acid 0.1
      Sodium hyaluronate 0.1
      Mentol 0.1
      Covafresh 0.03
      Characteristic Control group (n=107) Intervention group (n=116) P-value
      Age (yr) 50 (19–72) 51 (19–70)
      Sex >0.99
       Female 60 (56.1) 64 (55.2)
       Male 47 (43.9) 52 (44.8)
      ASA physical status
       I 57 (53.3) 63 (54.3) >0.99
       II 38 (35.5) 39 (33.6) >0.99
       III 12 (11.2) 14 (12.1) >0.99
      Comorbidity
       Hypertension 34 (31.8) 35 (30.2) >0.99
       Diabetes mellitus 16 (15.0) 18 (15.5) >0.99
       Cardiovascular disease 4 (3.7) 5 (4.3) >0.99
       COPD 3 (2.8) 4 (3.4) >0.99
       Neurologic disease 3 (2.8) 0 (0) 0.10
      Preoperative Rørvik score 29.8±6.8 30.1±7.2 0.77
      Goligher prolapse classification
       Grade III 44 (41.1) 46 (39.7) >0.99
       Grade IV 63 (59.0) 70 (60.3) >0.99
      Parameter No. of patients (%) P-value
      Control group (n=107) Intervention group (n=116)
      Patients receiving analgesics
       Week 1 53 (49.5) 42 (36.2) 0.05
       Week 2 45 (42.1) 26 (22.4) <0.01
       Week 3 22 (20.6) 7 (6.0) <0.01
       Week 4 7 (6.5) 0 (0) <0.01
      Patients with anal itching
       Week 1 46 (43.0) 26 (22.4) <0.01
       Week 2 26 (24.3) 15 (12.9) 0.03
       Week 3 30 (28.0) 7 (6.0) <0.01
       Week 4 15 (14.0) 0 (0) <0.01
      Patients with complete healing 88 (82.2) 116 (100) <0.01
      Table 1. Composition of Antroclean Fisioderm Intimate Cleaner (Dermofarma Italia)

      Percentages may not total 100 due to rounding.

      Table 2. Patients’ baseline demographics and characteristics (n=223)

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

      ASA, American Society of Anesthesiologists; COPD, chronic obstructive pulmonary disease.

      Table 3. Primary outcome parameters (n=223)

      Table 1.

      Table 2.

      Table 3.

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