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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 : September 7, 2022
Sponsor:
Information provided by (Responsible Party):
Duomed

Tracking Information
First Submitted Date September 3, 2020
First Posted Date September 25, 2020
Last Update Posted Date September 7, 2022
Actual Study Start Date February 8, 2021
Estimated Primary Completion Date November 30, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 21, 2020)
  • 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 21, 2020)
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Study Evaluating the Clinical Outcome of a Modified d'Hoore Technique for Laparoscopic Ventral Mesh Rectopexy
Official Title A Prospective Study Evaluating the Clinical Outcome of a Modified d'Hoore Technique for Laparoscopic Ventral Mesh Rectopexy
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 Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Female patients with primary rectal prolapse, rectocele and/or enterocele eligible for laparoscopic ventral mesh rectopexy.
Condition
  • Rectocele
  • Enterocele
  • Rectal Prolapse
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.
Study Groups/Cohorts Patients eligible for laparoscopic ventral mesh rectopexy
Female patients with primary rectal prolapse, rectocele and/or enterocele eligible for laparoscopic ventral mesh rectopexy (LVMR)
Intervention: Device: Ifabond (Péters surgical)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 21, 2020)
150
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2025
Estimated Primary Completion Date November 30, 2025   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
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
Listed Location Countries Belgium
Removed Location Countries  
 
Administrative Information
NCT Number NCT04564677
Other Study ID Numbers DM-ZOL-02
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Duomed
Original Responsible Party Same as current
Current Study Sponsor Duomed
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Anne Dams, MD Ziekenhuis Oost-Limburg (ZOL)
PRS Account Duomed
Verification Date September 2022