Enterocele, Rectal Prolapse, Rectocele
Conditions
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.
Interventions
DEVICEIfabond (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.
Sponsors
Duomed
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 re-interventions | At discharge (assessed up to 1 week) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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 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. |
| 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. |
Countries
Belgium
Contacts
Primary ContactStephanie De Munter, PhD
Backup ContactAnne Dams, MD
Outcome results
None listed