Rectal Prolapse Clinical Trial
— POP-01Official title:
A Prospective Study Evaluating the Clinical Outcome of a Modified d'Hoore Technique for Laparoscopic Ventral Mesh Rectopexy
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.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | December 31, 2025 |
Est. primary completion date | November 30, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Belgium | Ziekenhuis Oost-Limburg (ZOL) | Genk |
Lead Sponsor | Collaborator |
---|---|
Duomed |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Procedural efficacy - Number of participants with (serious) adverse events | Number of participants with (serious) adverse events = grade II Clavien-Dindo | During procedure | |
Primary | Procedural efficacy - Conversion rate to laparotomy during the index procedure | Number of conversions to laparotomy during the index procedure | During procedure | |
Primary | Procedural efficacy - Number of participants with (serious) adverse events | Number of participants with (serious) adverse events = grade II Clavien-Dindo | At discharge (assessed up to 1 week) | |
Primary | Procedural efficacy - Number of re-interventions | Number of re-interventions | At discharge (assessed up to 1 week) | |
Primary | Procedural efficacy - Number of participants with (serious) adverse events | Number of participants with (serious) adverse events = grade II Clavien-Dindo | Follow-up 1: 6 - 10 weeks after the procedure | |
Primary | Procedural efficacy - Number of re-interventions | Number of re-interventions | Follow-up 1: 6 - 10 weeks after the procedure | |
Primary | Procedural efficacy - Number of post-operative recurrences | Number of post-operative recurrences | Follow-up 1: 6 - 10 weeks after the procedure | |
Primary | Procedural efficacy - Number of participants with (serious) adverse events | Number of participants with (serious) adverse events = grade II Clavien-Dindo | Follow-up 2: 12 months after the procedure | |
Primary | Procedural efficacy - Number of re-interventions | Number of re-interventions | Follow-up 2: 12 months after the procedure | |
Primary | Procedural efficacy - Number of post-operative recurrences | Number of post-operative recurrences | Follow-up 2: 12 months after the procedure | |
Primary | Procedural efficacy - Number of participants with (serious) adverse events | Number of participants with (serious) adverse events = grade II Clavien-Dindo | Follow-up 3: 24 months after the procedure | |
Primary | Procedural efficacy - Number of re-interventions | Number of re-interventions | Follow-up 3: 24 months after procedure | |
Primary | Procedural efficacy - Number of post-operative recurrences | Number of post-operative recurrences | Follow-up 3: 24 months after the procedure | |
Primary | Procedural efficacy - Number of participants with (serious) adverse events | Number of participants with (serious) adverse events = grade II Clavien-Dindo | Follow-up 4: 36 months after the procedure | |
Primary | Procedural efficacy - Number of re-interventions | Number of re-interventions | Follow-up 4: 36 months after the procedure | |
Primary | Procedural efficacy - Number of post-operative recurrences | Number of post-operative recurrences | Follow-up 4: 36 months after the procedure | |
Secondary | Pre-operative abdominal pain by means of the Visual Analogue Scale (VAS) | 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. | At baseline | |
Secondary | Pre-operative vaginal pain by means of the Visual Analogue Scale (VAS) | 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. | At baseline | |
Secondary | Functional score - Obstructive Defecation Syndrome (ODS) score | 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. | At baseline | |
Secondary | Functional score - Cleveland Clinical Incontinence Score (CCIS) | 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. | At baseline | |
Secondary | Quality of life - Birmingham Bowel and Urinary Symptoms Questionnaire (BBUSQ) | 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. | At baseline | |
Secondary | Post-operative abdominal pain by means of the Visual Analogue Scale (VAS) | 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. | Follow-up 1: 6 - 10 weeks after the procedure | |
Secondary | Post-operative abdominal pain by means of the Visual Analogue Scale (VAS) | 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. | Follow-up 2: 12 months after the procedure | |
Secondary | Post-operative abdominal pain by means of the Visual Analogue Scale (VAS) | 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. | Follow-up 3: 24 months after the procedure | |
Secondary | Post-operative abdominal pain by means of the Visual Analogue Scale (VAS) | 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. | Follow-up 4: 36 months after the procedure | |
Secondary | Post-operative vaginal pain by means of the Visual Analogue Scale (VAS) | 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. | Follow-up 1: 6 - 10 weeks after the procedure | |
Secondary | Post-operative vaginal pain by means of the Visual Analogue Scale (VAS) | 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. | Follow-up 2: 12 months after the procedure | |
Secondary | Post-operative vaginal pain by means of the Visual Analogue Scale (VAS) | 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. | Follow-up 3: 24 months after the procedure | |
Secondary | Post-operative vaginal pain by means of the Visual Analogue Scale (VAS) | 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. | Follow-up 4: 36 months after the procedure | |
Secondary | Functional score - Obstructive Defecation Syndrome (ODS) score | 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. | Follow-up 1: 6 - 10 weeks after the procedure | |
Secondary | Functional score - Obstructive Defecation Syndrome (ODS) score | 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. | Follow-up 2: 12 months after the procedure | |
Secondary | Functional score - Obstructive Defecation Syndrome (ODS) score | 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. | Follow-up 3: 24 months after the procedure | |
Secondary | Functional score - Obstructive Defecation Syndrome (ODS) score | 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. | Follow-up 4: 36 months after the procedure | |
Secondary | Functional score - Cleveland Clinical Incontinence Score (CCIS) | 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. | Follow-up 1: 6 - 10 weeks after the procedure | |
Secondary | Functional score - Cleveland Clinical Incontinence Score (CCIS) | 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. | Follow-up 2: 12 months after the procedure | |
Secondary | Functional score - Cleveland Clinical Incontinence Score (CCIS) | 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. | Follow-up 3: 24 months after the procedure | |
Secondary | Functional score - Cleveland Clinical Incontinence Score (CCIS) | 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. | Follow-up 4: 36 months after the procedure | |
Secondary | Quality of life - Birmingham Bowel and Urinary Symptoms Questionnaire (BBUSQ) | 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. | Follow-up 1: 6 - 10 weeks after the procedure | |
Secondary | Quality of life - Birmingham Bowel and Urinary Symptoms Questionnaire (BBUSQ) | 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. | Follow-up 2: 12 months after the procedure | |
Secondary | Quality of life - Birmingham Bowel and Urinary Symptoms Questionnaire (BBUSQ) | 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. | Follow-up 3: 24 months after the procedure | |
Secondary | Quality of life - Birmingham Bowel and Urinary Symptoms Questionnaire (BBUSQ) | 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. | Follow-up 4: 36 months after the procedure |
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