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Intra-operative Adverse Events During Laparoscopic Ventral Mesh Rectopexy

Intra-operative Adverse Events During Laparoscopic Ventral Mesh Rectopexy

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02870192
Enrollment
200
Registered
2016-08-17
Start date
2017-01-31
Completion date
2018-01-31
Last updated
2016-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Prolapse

Keywords

Rectal Prolapse

Brief summary

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.

Detailed 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.

Interventions

Laparoscopic opening of the Daglous pouch, dissection till reach the levator ani muscle, mesh implementation and fixation, closure of the daglous. The mesh implemented may be synthetic or biological mesh.

Sponsors

University of Rome Tor Vergata
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* other condition than rectal prolapse

Design outcomes

Primary

MeasureTime frameDescription
intra-operative complications30 days postoperativeAll complications occur during the operation and discovered and managed during the operation or passed undiscovered and discovered postoperative during the same admission or require readmission

Contacts

Primary ContactMostafa Shalaby, MD, MSc
shalaby-mostafa@hotmail.com0039329353441
Backup ContactPierpaolo Sileri, MD, PhD
piersileri@yahoo.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026