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.
Study Type
OBSERVATIONAL
Enrollment
150
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.
Ziekenhuis Oost-Limburg (ZOL)
Genk, Belgium
RECRUITINGProcedural 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
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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