A Study Evaluating the Clinical Outcome of a Modified d'Hoore Technique for Laparoscopic Ventral Mesh Rectopexy

Study Overview
=================
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.

Official Title
-----------------
A Prospective Study Evaluating the Clinical Outcome of a Modified d'Hoore Technique for Laparoscopic Ventral Mesh Rectopexy

Conditions
-----------------
Rectocele, Enterocele, Rectal Prolapse

Intervention / Treatment
-----------------
* Device: Ifabond (Péters surgical)


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients eligible for laparoscopic ventral mesh rectopexy<br>Female patients with primary rectal prolapse, rectocele and/or enterocele eligible for laparoscopic ventral mesh rectopexy (LVMR) | Device: Ifabond (Péters surgical)<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural efficacy - Number of participants with (serious) adverse events | Number of participants with (serious) adverse events ≥ grade II Clavien-Dindo | During procedure | 
| Procedural efficacy - Conversion rate to laparotomy during the index procedure | Number of conversions to laparotomy during the index procedure | During procedure | 
| 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) | 
| Procedural efficacy - Number of re-interventions | Number of re-interventions | 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 | Follow-up 1: 6 - 10 weeks after the procedure | 
| Procedural efficacy - Number of re-interventions | Number of re-interventions | Follow-up 1: 6 - 10 weeks after the procedure | 
| Procedural efficacy - Number of post-operative recurrences | Number of post-operative recurrences | 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 | Follow-up 2: 12 months after the procedure | 
| Procedural efficacy - Number of re-interventions | Number of re-interventions | Follow-up 2: 12 months after the procedure | 
| Procedural efficacy - Number of post-operative recurrences | Number of post-operative recurrences | 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 | Follow-up 3: 24 months after the procedure | 
| Procedural efficacy - Number of re-interventions | Number of re-interventions | Follow-up 3: 24 months after procedure | 
| Procedural efficacy - Number of post-operative recurrences | Number of post-operative recurrences | 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 | Follow-up 4: 36 months after the procedure | 
| Procedural efficacy - Number of re-interventions | Number of re-interventions | Follow-up 4: 36 months after the procedure | 
| Procedural efficacy - Number of post-operative recurrences | Number of post-operative recurrences | Follow-up 4: 36 months after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |