NCT02870192

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 17, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

August 17, 2016

Status Verified

August 1, 2016

Enrollment Period

5 months

First QC Date

August 9, 2016

Last Update Submit

August 12, 2016

Conditions

Rectal Prolapse

Keywords

Rectal Prolapse

Outcome Measures

Primary Outcomes (1)

  • intra-operative complications

    All 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

    30 days postoperative

Study Arms (1)

Rectal Prolapse

EXPERIMENTAL

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

Procedure: Laparoscopic ventral mesh rectopexy

Interventions

Laparoscopic ventral mesh rectopexyPROCEDURE

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.

Rectal Prolapse

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • other condition than rectal prolapse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rectal Prolapse

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesPelvic Organ ProlapseProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Pierpaolo Sileri, MD, PhD

    University of Rome Tor Vergata

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mostafa Shalaby, MD, MSc

CONTACT

0039329353441shalaby-mostafa@hotmail.com

Pierpaolo Sileri, MD, PhD

CONTACT

piersileri@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

August 9, 2016

First Posted

August 17, 2016

Study Start

January 1, 2017

Primary Completion

June 1, 2017

Study Completion

January 1, 2018

Last Updated

August 17, 2016

Record last verified: 2016-08