A Study Evaluating the Clinical Outcome of a Modified d'Hoore Technique for Laparoscopic Ventral Mesh Rectopexy (POP-01)
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ClinicalTrials.gov Identifier: NCT04564677 |
Recruitment Status :
Recruiting
First Posted : September 25, 2020
Last Update Posted : October 10, 2023
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Condition or disease | Intervention/treatment |
---|---|
Rectocele Enterocele Rectal Prolapse | Device: Ifabond (Péters surgical) |
Study Type : | Observational |
Estimated Enrollment : | 150 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Official Title: | A Prospective Study Evaluating the Clinical Outcome of a Modified d'Hoore Technique for Laparoscopic Ventral Mesh Rectopexy |
Actual Study Start Date : | February 8, 2021 |
Estimated Primary Completion Date : | November 30, 2025 |
Estimated Study Completion Date : | December 31, 2025 |
Group/Cohort | Intervention/treatment |
---|---|
Patients eligible for laparoscopic ventral mesh rectopexy
Female patients with primary rectal prolapse, rectocele and/or enterocele eligible for laparoscopic ventral mesh rectopexy (LVMR)
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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. |
- Procedural efficacy - Number of participants with (serious) adverse events [ Time Frame: During procedure ]Number of participants with (serious) adverse events ≥ grade II Clavien-Dindo
- Procedural efficacy - Conversion rate to laparotomy during the index procedure [ Time Frame: During procedure ]Number of conversions to laparotomy during the index procedure
- Procedural efficacy - Number of participants with (serious) adverse events [ Time Frame: At discharge (assessed up to 1 week) ]Number of participants with (serious) adverse events ≥ grade II Clavien-Dindo
- Procedural efficacy - Number of re-interventions [ Time Frame: At discharge (assessed up to 1 week) ]Number of re-interventions
- Procedural efficacy - Number of participants with (serious) adverse events [ Time Frame: Follow-up 1: 6 - 10 weeks after the procedure ]Number of participants with (serious) adverse events ≥ grade II Clavien-Dindo
- Procedural efficacy - Number of re-interventions [ Time Frame: Follow-up 1: 6 - 10 weeks after the procedure ]Number of re-interventions
- Procedural efficacy - Number of post-operative recurrences [ Time Frame: Follow-up 1: 6 - 10 weeks after the procedure ]Number of post-operative recurrences
- Procedural efficacy - Number of participants with (serious) adverse events [ Time Frame: Follow-up 2: 12 months after the procedure ]Number of participants with (serious) adverse events ≥ grade II Clavien-Dindo
- Procedural efficacy - Number of re-interventions [ Time Frame: Follow-up 2: 12 months after the procedure ]Number of re-interventions
- Procedural efficacy - Number of post-operative recurrences [ Time Frame: Follow-up 2: 12 months after the procedure ]Number of post-operative recurrences
- Procedural efficacy - Number of participants with (serious) adverse events [ Time Frame: Follow-up 3: 24 months after the procedure ]Number of participants with (serious) adverse events ≥ grade II Clavien-Dindo
- Procedural efficacy - Number of re-interventions [ Time Frame: Follow-up 3: 24 months after procedure ]Number of re-interventions
- Procedural efficacy - Number of post-operative recurrences [ Time Frame: Follow-up 3: 24 months after the procedure ]Number of post-operative recurrences
- Procedural efficacy - Number of participants with (serious) adverse events [ Time Frame: 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 [ Time Frame: Follow-up 4: 36 months after the procedure ]Number of re-interventions
- Procedural efficacy - Number of post-operative recurrences [ Time Frame: Follow-up 4: 36 months after the procedure ]Number of post-operative recurrences
- Pre-operative abdominal pain by means of the Visual Analogue Scale (VAS) [ Time Frame: 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.
- Pre-operative vaginal pain by means of the Visual Analogue Scale (VAS) [ Time Frame: 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.
- Functional score - Obstructive Defecation Syndrome (ODS) score [ Time Frame: At baseline ]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.
- Functional score - Cleveland Clinical Incontinence Score (CCIS) [ Time Frame: At baseline ]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) [ Time Frame: At baseline ]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.
- Post-operative abdominal pain by means of the Visual Analogue Scale (VAS) [ Time Frame: Follow-up 1: 6 - 10 weeks 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.
- Post-operative abdominal pain by means of the Visual Analogue Scale (VAS) [ Time Frame: Follow-up 2: 12 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.
- Post-operative abdominal pain by means of the Visual Analogue Scale (VAS) [ Time Frame: Follow-up 3: 24 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.
- Post-operative abdominal pain by means of the Visual Analogue Scale (VAS) [ Time Frame: 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.
- Post-operative vaginal pain by means of the Visual Analogue Scale (VAS) [ Time Frame: Follow-up 1: 6 - 10 weeks 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.
- Post-operative vaginal pain by means of the Visual Analogue Scale (VAS) [ Time Frame: Follow-up 2: 12 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.
- Post-operative vaginal pain by means of the Visual Analogue Scale (VAS) [ Time Frame: Follow-up 3: 24 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.
- Post-operative vaginal pain by means of the Visual Analogue Scale (VAS) [ Time Frame: 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.
- Functional score - Obstructive Defecation Syndrome (ODS) score [ Time Frame: Follow-up 1: 6 - 10 weeks 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.
- Functional score - Obstructive Defecation Syndrome (ODS) score [ Time Frame: Follow-up 2: 12 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.
- Functional score - Obstructive Defecation Syndrome (ODS) score [ Time Frame: Follow-up 3: 24 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.
- Functional score - Obstructive Defecation Syndrome (ODS) score [ Time Frame: 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.
- Functional score - Cleveland Clinical Incontinence Score (CCIS) [ Time Frame: Follow-up 1: 6 - 10 weeks 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.
- Functional score - Cleveland Clinical Incontinence Score (CCIS) [ Time Frame: Follow-up 2: 12 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.
- Functional score - Cleveland Clinical Incontinence Score (CCIS) [ Time Frame: Follow-up 3: 24 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.
- Functional score - Cleveland Clinical Incontinence Score (CCIS) [ Time Frame: 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) [ Time Frame: Follow-up 1: 6 - 10 weeks 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.
- Quality of life - Birmingham Bowel and Urinary Symptoms Questionnaire (BBUSQ) [ Time Frame: Follow-up 2: 12 months after the procedure ]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.
- Quality of life - Birmingham Bowel and Urinary Symptoms Questionnaire (BBUSQ) [ Time Frame: Follow-up 3: 24 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.
- Quality of life - Birmingham Bowel and Urinary Symptoms Questionnaire (BBUSQ) [ Time Frame: 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04564677
Contact: Stephanie De Munter, PhD | +32 (0)11 28 69 48 | stephanie.de.munter@archerresearch.eu | |
Contact: Anne Dams, MD | +32 (0)89 32 60 20 | anne.dams@zol.be |
Belgium | |
Ziekenhuis Oost-Limburg (ZOL) | Recruiting |
Genk, Belgium | |
Contact: Anne Dams, MD +32 (0)89 32 60 20 |
Principal Investigator: | Anne Dams, MD | Ziekenhuis Oost-Limburg (ZOL) |
Responsible Party: | Duomed |
ClinicalTrials.gov Identifier: | NCT04564677 |
Other Study ID Numbers: |
DM-ZOL-02 |
First Posted: | September 25, 2020 Key Record Dates |
Last Update Posted: | October 10, 2023 |
Last Verified: | October 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Rectal Prolapse Rectocele Prolapse Hernia Pathological Conditions, Anatomical |
Rectal Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases Pelvic Organ Prolapse |