POP-01: A Study Evaluating the Clinical Outcome of a Modified d'Hoore Technique for Laparoscopic Ventral Mesh Rectopexy
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | 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.
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Outcome Measures
Primary Outcome Measures
- Procedural efficacy - Number of participants with (serious) adverse events [During procedure]
Number of participants with (serious) adverse events ≥ grade II Clavien-Dindo
- Procedural efficacy - Conversion rate to laparotomy during the index procedure [During procedure]
Number of conversions to laparotomy during the index procedure
- Procedural efficacy - Number of participants with (serious) adverse events [At discharge (assessed up to 1 week)]
Number of participants with (serious) adverse events ≥ grade II Clavien-Dindo
- Procedural efficacy - Number of re-interventions [At discharge (assessed up to 1 week)]
Number of re-interventions
- Procedural efficacy - Number of participants with (serious) adverse events [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 [Follow-up 1: 6 - 10 weeks after the procedure]
Number of re-interventions
- Procedural efficacy - Number of post-operative recurrences [Follow-up 1: 6 - 10 weeks after the procedure]
Number of post-operative recurrences
- Procedural efficacy - Number of participants with (serious) adverse events [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 [Follow-up 2: 12 months after the procedure]
Number of re-interventions
- Procedural efficacy - Number of post-operative recurrences [Follow-up 2: 12 months after the procedure]
Number of post-operative recurrences
- Procedural efficacy - Number of participants with (serious) adverse events [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 [Follow-up 3: 24 months after procedure]
Number of re-interventions
- Procedural efficacy - Number of post-operative recurrences [Follow-up 3: 24 months after the procedure]
Number of post-operative recurrences
- Procedural efficacy - Number of participants with (serious) adverse events [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 [Follow-up 4: 36 months after the procedure]
Number of re-interventions
- Procedural efficacy - Number of post-operative recurrences [Follow-up 4: 36 months after the procedure]
Number of post-operative recurrences
Secondary Outcome Measures
- Pre-operative abdominal pain by means of the Visual Analogue Scale (VAS) [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) [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 [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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 [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 [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 [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 [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) [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) [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) [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) [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) [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) [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) [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) [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Female patients.
-
Patient ≥ 18 years of age at study entry.
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Patient and investigator signed and dated the informed consent form prior to the index-procedure.
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Patient with primary rectal prolapse (grades I to V according to the Oxford scale), rectocele and/or enterocele.
Exclusion Criteria:
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Patient is unable / unwilling to provide informed consent.
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Patient with recurrent rectal prolapse, rectocele and/or enterocele.
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Patient is unable to comply with the study protocol or proposed follow-up visits.
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Patient has a contra-indication for laparoscopic ventral mesh rectopexy.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ziekenhuis Oost-Limburg (ZOL) | Genk | Belgium |
Sponsors and Collaborators
- Duomed
Investigators
- Principal Investigator: Anne Dams, MD, Ziekenhuis Oost-Limburg (ZOL)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DM-ZOL-02