An observational study in Rectocele, Enterocele and Rectal Prolapse, sponsored by Duomed. Recruiting at 1 site in Belgium. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-10.
Sponsored by Duomed · Observational
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.
50 studies on the registry are indexed under Rectocele; 9 are open to participants now.
This study's planned enrollment of 150 is above the median of 113 across 13 observational studies indexed under Rectocele.
Browse Rectocele studies →Duomed is the lead sponsor of 12 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Female patients with primary rectal prolapse, rectocele and/or enterocele eligible for laparoscopic ventral mesh rectopexy.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedural efficacy - Number of participants with (serious) adverse events
Number of participants with (serious) adverse events ≥ grade II Clavien-Dindo
Time frame: During procedure
Procedural efficacy - Conversion rate to laparotomy during the index procedure
Number of conversions to laparotomy during the index procedure
Time frame: During procedure
Procedural efficacy - Number of participants with (serious) adverse events
Number of participants with (serious) adverse events ≥ grade II Clavien-Dindo
Time frame: At discharge (assessed up to 1 week)
Procedural efficacy - Number of re-interventions
Number of re-interventions
Time frame: At discharge (assessed up to 1 week)
Procedural efficacy - Number of participants with (serious) adverse events
Number of participants with (serious) adverse events ≥ grade II Clavien-Dindo
Time frame: Follow-up 1: 6 - 10 weeks after the procedure
Procedural efficacy - Number of re-interventions
Number of re-interventions
Time frame: Follow-up 1: 6 - 10 weeks after the procedure
Procedural efficacy - Number of post-operative recurrences
Number of post-operative recurrences
Time frame: Follow-up 1: 6 - 10 weeks after the procedure
Procedural efficacy - Number of participants with (serious) adverse events
Number of participants with (serious) adverse events ≥ grade II Clavien-Dindo
Time frame: Follow-up 2: 12 months after the procedure
Procedural efficacy - Number of re-interventions
Number of re-interventions
Time frame: Follow-up 2: 12 months after the procedure
Procedural efficacy - Number of post-operative recurrences
Number of post-operative recurrences
Time frame: Follow-up 2: 12 months after the procedure
Procedural efficacy - Number of participants with (serious) adverse events
Number of participants with (serious) adverse events ≥ grade II Clavien-Dindo
Time frame: Follow-up 3: 24 months after the procedure
Procedural efficacy - Number of re-interventions
Number of re-interventions
Time frame: Follow-up 3: 24 months after procedure
Procedural efficacy - Number of post-operative recurrences
Number of post-operative recurrences
Time frame: Follow-up 3: 24 months after the procedure
Procedural efficacy - Number of participants with (serious) adverse events
Number of participants with (serious) adverse events ≥ grade II Clavien-Dindo
Time frame: Follow-up 4: 36 months after the procedure
Procedural efficacy - Number of re-interventions
Number of re-interventions
Time frame: Follow-up 4: 36 months after the procedure
Procedural efficacy - Number of post-operative recurrences
Number of post-operative recurrences
Time frame: Follow-up 4: 36 months after the procedure
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.
Time frame: At baseline
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.
Time frame: At baseline
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.
Time frame: At baseline
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.
Time frame: At baseline
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.
Time frame: At baseline
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.
Time frame: Follow-up 1: 6 - 10 weeks after the procedure
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.
Time frame: Follow-up 2: 12 months after the procedure
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.
Time frame: Follow-up 3: 24 months after the procedure
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.
Time frame: Follow-up 4: 36 months after the procedure
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.
Time frame: Follow-up 1: 6 - 10 weeks after the procedure
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.
Time frame: Follow-up 2: 12 months after the procedure
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.
Time frame: Follow-up 3: 24 months after the procedure
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.
Time frame: Follow-up 4: 36 months after the procedure
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.
Time frame: Follow-up 1: 6 - 10 weeks after the procedure
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.
Time frame: Follow-up 2: 12 months after the procedure
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.
Time frame: Follow-up 3: 24 months after the procedure
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.
Time frame: Follow-up 4: 36 months after the procedure
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.
Time frame: Follow-up 1: 6 - 10 weeks after the procedure
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.
Time frame: Follow-up 2: 12 months after the procedure
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.
Time frame: Follow-up 3: 24 months after the procedure
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.
Time frame: Follow-up 4: 36 months after the procedure
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.
Time frame: Follow-up 1: 6 - 10 weeks after the procedure
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.
Time frame: Follow-up 2: 12 months after the procedure
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.
Time frame: Follow-up 3: 24 months after the procedure
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.
Time frame: Follow-up 4: 36 months after the procedure
Plan to share: No
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