A Study Evaluating the Clinical Outcome of a Modified d'Hoore Technique for Laparoscopic Ventral Mesh Rectopexy

Recruiting

• Conditions: Enterocele; Rectocele; Rectal Prolapse
• Interventions: Device: Ifabond (Péters surgical)

• Registration Number: NCT04564677
• Lead Sponsor: Duomed

Brief Summary

The purpose of this observational study is to evaluate the clinical outcome of a modified d'Hoore technique for laparoscopic ventral mesh rectopexy in patients with primary rectal prolapse, rectocele and/or enterocele.The goal of the study will be achieved by reporting the peri- and postoperative complications ((serious) adverse events), recurrences and re-interventions. Pre-operative to postoperative changes in pain, functional outcome and quality of life will be evaluated as well.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-03
• Study First Submitted QC: 2020-09-21
• Study First Posted: 2020-09-25
• Study Start: 2021-02-08
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-09
• Last Update Posted: 2023-10-10
• Primary Completion: 2025-11-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

• Female patients.
• Patient ≥ 18 years of age at study entry.
• Patient and investigator signed and dated the informed consent form prior to the index-procedure.
• Patient with primary rectal prolapse (grades I to V according to the Oxford scale), rectocele and/or enterocele.

Exclusion Criteria

• Patient is unable / unwilling to provide informed consent.
• Patient with recurrent rectal prolapse, rectocele and/or enterocele.
• Patient is unable to comply with the study protocol or proposed follow-up visits.
• Patient has a contra-indication for laparoscopic ventral mesh rectopexy.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients eligible for laparoscopic ventral mesh rectopexy	Ifabond (Péters surgical)	Female patients with primary rectal prolapse, rectocele and/or enterocele eligible for laparoscopic ventral mesh rectopexy (LVMR)

Primary Outcome Measures

Name	Time	Method
Procedural efficacy - Number of participants with (serious) adverse events	Follow-up 4: 36 months after the procedure	Number of participants with (serious) adverse events ≥ grade II Clavien-Dindo
Procedural efficacy - Number of re-interventions	Follow-up 4: 36 months after the procedure	Number of re-interventions
Procedural efficacy - Conversion rate to laparotomy during the index procedure	During procedure	Number of conversions to laparotomy during the index procedure
Procedural efficacy - Number of post-operative recurrences	Follow-up 4: 36 months after the procedure	Number of post-operative recurrences

Secondary Outcome Measures

Name	Time	Method
Functional score - Obstructive Defecation Syndrome (ODS) score	Follow-up 4: 36 months after the procedure	The ODS score is obtained by means of a structured 8-item questionnaire on multiple bowel symptoms. The cumulative score for all answers ranges from 0 to 31, with higher scores being indicative of more severe symptoms.
Post-operative abdominal pain by means of the Visual Analogue Scale (VAS)	Follow-up 4: 36 months after the procedure	Assessment of post-operative abdominal pain by means of the VAS, which contains a 0 to 100 grading scale with 0 equaling no pain and 100 equaling the worst conceivable pain.
Pre-operative abdominal pain by means of the Visual Analogue Scale (VAS)	At baseline	Assessment of pre-operative abdominal pain by means of the VAS, which contains a 0 to 100 grading scale with 0 equaling no pain and 100 equaling the worst conceivable pain.
Functional score - Cleveland Clinical Incontinence Score (CCIS)	Follow-up 4: 36 months after the procedure	The CCIS is a 5-item questionnaire used to score the level of fecal incontinence. The cumulative score ranges from 0 to 20, with higher scores being indicative of more severe symptoms.
Quality of life - Birmingham Bowel and Urinary Symptoms Questionnaire (BBUSQ)	Follow-up 4: 36 months after the procedure	The BBUSQ is a 22-item questionnaire to record data on 4 domains: constipation, evacuation, incontinence and urinary symptoms. Higher scores are indicative of more severe symptoms.
Pre-operative vaginal pain by means of the Visual Analogue Scale (VAS)	At baseline	Assessment of pre-operative vaginal pain by means of the VAS, which contains a 0 to 100 grading scale with 0 equaling no pain and 100 equaling the worst conceivable pain.
Post-operative vaginal pain by means of the Visual Analogue Scale (VAS)	Follow-up 4: 36 months after the procedure	Assessment of post-operative vaginal pain by means of the VAS, which contains a 0 to 100 grading scale with 0 equaling no pain and 100 equaling the worst conceivable pain.

Trial Locations

Locations (1)

Ziekenhuis Oost-Limburg (ZOL); 🇧🇪 Genk, Belgium