ClinicalTrials.gov

History of Changes for Study: NCT04564677
A Study Evaluating the Clinical Outcome of a Modified d'Hoore Technique for Laparoscopic Ventral Mesh Rectopexy (POP-01)
Latest version (submitted September 5, 2022) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 September 21, 2020 None (earliest Version on record)
2 February 1, 2021 Study Status
3 February 16, 2021 Recruitment Status, Study Status, Contacts/Locations and Oversight
4 January 7, 2022 Study Status
5 September 5, 2022 Study Status
Comparison Format:

Scroll up to access the controls

Study NCT04564677
Submitted Date:  September 21, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: DM-ZOL-02
Brief Title: A Study Evaluating the Clinical Outcome of a Modified d'Hoore Technique for Laparoscopic Ventral Mesh Rectopexy (POP-01)
Official Title: A Prospective Study Evaluating the Clinical Outcome of a Modified d'Hoore Technique for Laparoscopic Ventral Mesh Rectopexy
Secondary IDs:
Open or close this module Study Status
Record Verification: September 2020
Overall Status: Not yet recruiting
Study Start: October 19, 2020
Primary Completion: November 30, 2025 [Anticipated]
Study Completion: December 31, 2025 [Anticipated]
First Submitted: September 3, 2020
First Submitted that
Met QC Criteria:
September 21, 2020
First Posted: September 25, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
September 21, 2020
Last Update Posted: September 25, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Duomed
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring:
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Rectocele
Enterocele
Rectal Prolapse
Keywords:
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Case-Only
Time Perspective: Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 150 [Anticipated]
Number of Groups/Cohorts 1
Open or close this module Groups and Interventions
Groups/Cohorts Interventions
Patients eligible for laparoscopic ventral mesh rectopexy
Female patients with primary rectal prolapse, rectocele and/or enterocele eligible for laparoscopic ventral mesh rectopexy (LVMR)
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.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Procedural efficacy - Number of participants with (serious) adverse events
[ Time Frame: During procedure ]

Number of participants with (serious) adverse events ≥ grade II Clavien-Dindo
2. Procedural efficacy - Conversion rate to laparotomy during the index procedure
[ Time Frame: During procedure ]

Number of conversions to laparotomy during the index procedure
3. 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
4. Procedural efficacy - Number of re-interventions
[ Time Frame: At discharge (assessed up to 1 week) ]

Number of re-interventions
5. 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
6. Procedural efficacy - Number of re-interventions
[ Time Frame: Follow-up 1: 6 - 10 weeks after the procedure ]

Number of re-interventions
7. Procedural efficacy - Number of post-operative recurrences
[ Time Frame: Follow-up 1: 6 - 10 weeks after the procedure ]

Number of post-operative recurrences
8. 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
9. Procedural efficacy - Number of re-interventions
[ Time Frame: Follow-up 2: 12 months after the procedure ]

Number of re-interventions
10. Procedural efficacy - Number of post-operative recurrences
[ Time Frame: Follow-up 2: 12 months after the procedure ]

Number of post-operative recurrences
11. 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
12. Procedural efficacy - Number of re-interventions
[ Time Frame: Follow-up 3: 24 months after procedure ]

Number of re-interventions
13. Procedural efficacy - Number of post-operative recurrences
[ Time Frame: Follow-up 3: 24 months after the procedure ]

Number of post-operative recurrences
14. 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
15. Procedural efficacy - Number of re-interventions
[ Time Frame: Follow-up 4: 36 months after the procedure ]

Number of re-interventions
16. Procedural efficacy - Number of post-operative recurrences
[ Time Frame: Follow-up 4: 36 months after the procedure ]

Number of post-operative recurrences
Secondary Outcome Measures:
1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.
9. 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.
10. 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.
11. 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.
12. 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.
13. 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.
14. 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.
15. 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.
16. 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.
17. 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.
18. 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.
19. 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.
20. 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.
21. 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.
22. 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.
23. 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.
24. 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.
25. 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.
Open or close this module Eligibility
Study Population: Female patients with primary rectal prolapse, rectocele and/or enterocele eligible for laparoscopic ventral mesh rectopexy.
Sampling Method: Non-Probability Sample
Minimum Age: 18 Years
Maximum Age:
Sex: Female
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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.
Open or close this module Contacts/Locations
Central Contact Person: Stephanie De Munter, PhD
Telephone: +32 (0)11 28 69 48
Email: stephanie.de.munter@archerresearch.eu
Central Contact Backup: Anne Dams, MD
Telephone: +32 (0)89 32 60 20
Email: anne.dams@zol.be
Study Officials: Anne Dams, MD
Principal Investigator
Ziekenhuis Oost-Limburg (ZOL)
Locations: Belgium
Ziekenhuis Oost-Limburg (ZOL)
Genk, Belgium
Contact:Contact: Anne Dams, MD +32 (0)89 32 60 20
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services