Intra-operative Adverse Events During Laparoscopic Ventral Mesh Rectopexy

University of Rome Tor Vergata

Status: Unknown

Conditions: Rectal Prolapse

Treatments: Procedure: Laparoscopic ventral mesh rectopexy

Study type: Interventional

Funder types: Other

Identifiers

NCT02870192

91/12

Details and patient eligibility

About

Outcomes of laparoscopic ventral mesh rectopexy are well known, but data on intra-operative adverse events is scant. A multicenter pool-analysis of prospectively collected database on 1384 patients with internal/external rectal prolapse toke place. Overall 72 (5%) patients experienced complications, 41 discovered and managed intraoperatively, 22 postoperative complications, and 9 required readmission. Despite accepted lower rate of morbidity, these results come from four well equipped European centers by four surgeons practiced at least 200 LVMR.

Full description

Multicenter pooled-analysis of LVMR for internal/external rectal prolapse. All events occurred and discovered intra-operatively or passed undiagnosed and appeared within 30-days postoperatively (same admission/readmission) will included, with classification according to the Clavien-Dindo classification.

Enrollment: 200 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• all patients underwent laparoscopic ventral mesh rectopexy for internal and external rectal prolapse

Exclusion criteria

• other condition than rectal prolapse

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

200 participants in 1 patient group

Rectal Prolapse

Experimental group

Description:

Patients with rectal prolapse, who will underwent laparoscopic ventral mesh rectopexy. The implemented mesh may be synthetic or biological.

Treatment:

Procedure: Laparoscopic ventral mesh rectopexy