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Intra-operative Adverse Events During Laparoscopic Ventral Mesh Rectopexy

U

University of Rome Tor Vergata

Status

Unknown

Conditions

Rectal Prolapse

Treatments

Procedure: Laparoscopic ventral mesh rectopexy

Study type

Interventional

Funder types

Other

Identifiers

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

Trial contacts and locations

0

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Central trial contact

Mostafa Shalaby, MD, MSc; Pierpaolo Sileri, MD, PhD

Data sourced from clinicaltrials.gov

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