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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04564677
Other study ID # DM-ZOL-02
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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