A Study Evaluating the Clinical Outcome of a Modified d'Hoore Technique for Laparoscopic Ventral Mesh Rectopexy (POP-01)

Duomed

Status

Enrolling

Conditions

Enterocele

Rectal Prolapse

Rectocele

Treatments

Device: Ifabond (Péters surgical)

Study type

Observational

Funder types

Industry

Identifiers

NCT04564677

DM-ZOL-02

Details and patient eligibility

About

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.

Enrollment

150 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.