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A Study Evaluating the Clinical Outcome of a Modified d'Hoore Technique for Laparoscopic Ventral Mesh Rectopexy (POP-01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04564677
Recruitment Status : Recruiting
First Posted : September 25, 2020
Last Update Posted : January 11, 2022
Sponsor:
Information provided by (Responsible Party):
Duomed

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.

Condition or disease Intervention/treatment
Rectocele Enterocele Rectal Prolapse Device: Ifabond (Péters surgical)

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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

Resource links provided by the National Library of Medicine


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)
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.




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.



Information from the National Library of Medicine

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.


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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
Study Population
Female patients with primary rectal prolapse, rectocele and/or enterocele eligible for laparoscopic ventral mesh rectopexy.
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.

Information from the National Library of Medicine

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


Contacts
Layout table for location 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

Locations
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Belgium
Ziekenhuis Oost-Limburg (ZOL) Recruiting
Genk, Belgium
Contact: Anne Dams, MD    +32 (0)89 32 60 20      
Sponsors and Collaborators
Duomed
Investigators
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Principal Investigator: Anne Dams, MD Ziekenhuis Oost-Limburg (ZOL)
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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: January 11, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rectal Prolapse
Rectocele
Prolapse
Hernia
Pathological Conditions, Anatomical
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pelvic Organ Prolapse