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

Rectal Prolapse Clinical Trial

— POP-01  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04564677
• Other study ID #: DM-ZOL-02
• Status: Recruiting
• Start date: February 8, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: October 2023
• Source: Duomed
• Contact: Stephanie De Munter, PhD
• Phone: +32 (0)11 28 69 48
• Email: stephanie.de.munter[@]archerresearch.eu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2025
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Enterocele
• Hernia
• Prolapse
• Rectal Prolapse
• Rectocele

Intervention

Device:
• Ifabond (Péters surgical)
Ifabond (Péters surgical) is a CE-marked synthetic surgical glue for internal and external use. The glue is non-toxic, biocompatible and biodegradable. It is commercially available and can be used for mesh fixation, as tissue adhesive, for sealing of sutured tissue and for hemostasis.

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg (ZOL)	Genk

Sponsors (1)

Lead Sponsor	Collaborator
Duomed

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedural efficacy - Number of participants with (serious) adverse events	Number of participants with (serious) adverse events = grade II Clavien-Dindo	During procedure
Primary	Procedural efficacy - Conversion rate to laparotomy during the index procedure	Number of conversions to laparotomy during the index procedure	During procedure
Primary	Procedural efficacy - Number of participants with (serious) adverse events	Number of participants with (serious) adverse events = grade II Clavien-Dindo	At discharge (assessed up to 1 week)
Primary	Procedural efficacy - Number of re-interventions	Number of re-interventions	At discharge (assessed up to 1 week)
Primary	Procedural efficacy - Number of participants with (serious) adverse events	Number of participants with (serious) adverse events = grade II Clavien-Dindo	Follow-up 1: 6 - 10 weeks after the procedure
Primary	Procedural efficacy - Number of re-interventions	Number of re-interventions	Follow-up 1: 6 - 10 weeks after the procedure
Primary	Procedural efficacy - Number of post-operative recurrences	Number of post-operative recurrences	Follow-up 1: 6 - 10 weeks after the procedure
Primary	Procedural efficacy - Number of participants with (serious) adverse events	Number of participants with (serious) adverse events = grade II Clavien-Dindo	Follow-up 2: 12 months after the procedure
Primary	Procedural efficacy - Number of re-interventions	Number of re-interventions	Follow-up 2: 12 months after the procedure
Primary	Procedural efficacy - Number of post-operative recurrences	Number of post-operative recurrences	Follow-up 2: 12 months after the procedure
Primary	Procedural efficacy - Number of participants with (serious) adverse events	Number of participants with (serious) adverse events = grade II Clavien-Dindo	Follow-up 3: 24 months after the procedure
Primary	Procedural efficacy - Number of re-interventions	Number of re-interventions	Follow-up 3: 24 months after procedure
Primary	Procedural efficacy - Number of post-operative recurrences	Number of post-operative recurrences	Follow-up 3: 24 months after the procedure
Primary	Procedural efficacy - Number of participants with (serious) adverse events	Number of participants with (serious) adverse events = grade II Clavien-Dindo	Follow-up 4: 36 months after the procedure
Primary	Procedural efficacy - Number of re-interventions	Number of re-interventions	Follow-up 4: 36 months after the procedure
Primary	Procedural efficacy - Number of post-operative recurrences	Number of post-operative recurrences	Follow-up 4: 36 months after the procedure
Secondary	Pre-operative abdominal pain by means of the Visual Analogue Scale (VAS)	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.	At baseline
Secondary	Pre-operative vaginal pain by means of the Visual Analogue Scale (VAS)	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.	At baseline
Secondary	Functional score - Obstructive Defecation Syndrome (ODS) score	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.	At baseline
Secondary	Functional score - Cleveland Clinical Incontinence Score (CCIS)	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.	At baseline
Secondary	Quality of life - Birmingham Bowel and Urinary Symptoms Questionnaire (BBUSQ)	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.	At baseline
Secondary	Post-operative abdominal pain by means of the Visual Analogue Scale (VAS)	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.	Follow-up 1: 6 - 10 weeks after the procedure
Secondary	Post-operative abdominal pain by means of the Visual Analogue Scale (VAS)	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.	Follow-up 2: 12 months after the procedure
Secondary	Post-operative abdominal pain by means of the Visual Analogue Scale (VAS)	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.	Follow-up 3: 24 months after the procedure
Secondary	Post-operative abdominal pain by means of the Visual Analogue Scale (VAS)	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.	Follow-up 4: 36 months after the procedure
Secondary	Post-operative vaginal pain by means of the Visual Analogue Scale (VAS)	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.	Follow-up 1: 6 - 10 weeks after the procedure
Secondary	Post-operative vaginal pain by means of the Visual Analogue Scale (VAS)	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.	Follow-up 2: 12 months after the procedure
Secondary	Post-operative vaginal pain by means of the Visual Analogue Scale (VAS)	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.	Follow-up 3: 24 months after the procedure
Secondary	Post-operative vaginal pain by means of the Visual Analogue Scale (VAS)	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.	Follow-up 4: 36 months after the procedure
Secondary	Functional score - Obstructive Defecation Syndrome (ODS) score	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.	Follow-up 1: 6 - 10 weeks after the procedure
Secondary	Functional score - Obstructive Defecation Syndrome (ODS) score	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.	Follow-up 2: 12 months after the procedure
Secondary	Functional score - Obstructive Defecation Syndrome (ODS) score	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.	Follow-up 3: 24 months after the procedure
Secondary	Functional score - Obstructive Defecation Syndrome (ODS) score	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.	Follow-up 4: 36 months after the procedure
Secondary	Functional score - Cleveland Clinical Incontinence Score (CCIS)	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.	Follow-up 1: 6 - 10 weeks after the procedure
Secondary	Functional score - Cleveland Clinical Incontinence Score (CCIS)	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.	Follow-up 2: 12 months after the procedure
Secondary	Functional score - Cleveland Clinical Incontinence Score (CCIS)	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.	Follow-up 3: 24 months after the procedure
Secondary	Functional score - Cleveland Clinical Incontinence Score (CCIS)	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.	Follow-up 4: 36 months after the procedure
Secondary	Quality of life - Birmingham Bowel and Urinary Symptoms Questionnaire (BBUSQ)	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.	Follow-up 1: 6 - 10 weeks after the procedure
Secondary	Quality of life - Birmingham Bowel and Urinary Symptoms Questionnaire (BBUSQ)	The BBUSQ is a 22-item questionnaire to record data on 4 domains: constipation, evacuation, incontinence and urinart symptoms. Higher scores are indicative of more severe symptoms.	Follow-up 2: 12 months after the procedure
Secondary	Quality of life - Birmingham Bowel and Urinary Symptoms Questionnaire (BBUSQ)	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.	Follow-up 3: 24 months after the procedure
Secondary	Quality of life - Birmingham Bowel and Urinary Symptoms Questionnaire (BBUSQ)	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.	Follow-up 4: 36 months after the procedure