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Status unknownNCT02870192Updated Aug 17, 2016

Intra-operative Adverse Events During Laparoscopic Ventral Mesh Rectopexy

An interventional study of Laparoscopic ventral mesh rectopexy in Rectal Prolapse, sponsored by University of Rome Tor Vergata. Status unknown. Per ClinicalTrials.gov, last updated 2016-08-17.

Sponsored by University of Rome Tor Vergata · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Aug 2016), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Not applicable
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Rectal Prolapse

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Keywords

  • Rectal Prolapse
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In context

Rectal Prolapse

55 studies on the registry are indexed under Rectal Prolapse; 12 are open to participants now.

This study's planned enrollment of 200 is above the median of 55 across 34 interventional studies indexed under Rectal Prolapse.

Browse Rectal Prolapse studies →

Lead sponsor

University of Rome Tor Vergata is the lead sponsor of 96 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • other condition than rectal prolapse
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Rectal Prolapse

    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

  • ProcedureLaparoscopic ventral mesh rectopexy

    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.

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What researchers measure

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

    Time frame: 30 days postoperative

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 17, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02870192
Lead sponsor
University of Rome Tor Vergata
Responsible party
Pierpaolo Sileri (Prof, University of Rome Tor Vergata) — Principal investigator
First posted
Aug 17, 2016
Start date
Jan 2017
Primary completion
Jun 2017 (estimated)
Completion
Jan 2018 (estimated)
Last update
Aug 17, 2016

Study contacts

Mostafa Shalaby, MD, MSc
Contact
shalaby-mostafa@hotmail.com
0039329353441
Pierpaolo Sileri, MD, PhD
Contact
piersileri@yahoo.com
Pierpaolo Sileri, MD, PhD
principal investigator · University of Rome Tor Vergata

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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