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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Belgium
Ziekenhuis Oost-Limburg (ZOL)
RECRUITING
Genk
Contact Information
Primary
Stephanie De Munter, PhD
stephanie.de.munter@archerresearch.eu
+32 (0)11 28 69 48
Backup
Anne Dams, MD
anne.dams@zol.be
+32 (0)89 32 60 20
Time Frame
Start Date: 2021-02-08
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 150
Treatments
Patients eligible for laparoscopic ventral mesh rectopexy
Female patients with primary rectal prolapse, rectocele and/or enterocele eligible for laparoscopic ventral mesh rectopexy (LVMR)
Related Therapeutic Areas
Sponsors
Leads: Duomed

This content was sourced from clinicaltrials.gov