NCT02601326

Brief Summary

A comparative randomized study between laparoscopic ventral mesh Rectopexy and Delorme's procedure in treatment of complete rectal prolapse to ass both efficacy and complications

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 28, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 10, 2015

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 16, 2016

Status Verified

November 1, 2015

Enrollment Period

2 years

First QC Date

October 28, 2015

Last Update Submit

March 14, 2016

Conditions

Complete Rectal Prolapse

Outcome Measures

Primary Outcomes (1)

  • Recurrence of the condition

    Measured by counting the number of patients with recurrence of rectal prolapse

    18 month

Study Arms (2)

Laparoscopic ventral mesh Rectopexy

ACTIVE COMPARATOR

Fixation of the rectum to the sacrum using laparoscopy and mesh

Procedure: Laparoscopic ventral mesh Rectopexy

delorme's procedure

ACTIVE COMPARATOR

excision of excess rectal mucosa under spinal anesthesia then plication of the rectal muscles with vicryl 2/0 sutures

Procedure: Delorme's procedure

Interventions

Laparoscopic ventral mesh RectopexyPROCEDURE

Laparoscopic fixation of rectum to sacral promontory using mesh

Laparoscopic ventral mesh Rectopexy
Delorme's procedurePROCEDURE

Transanal excision of rectal mucosa and plication of muscle layer

delorme's procedure

Eligibility Criteria

Age16 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients with complete rectal prolapse

You may not qualify if:

  • patients who underwent previous surgery for complete rectal prolapse
  • patients unfit for surgery
  • patients with associated colorectal diseases or pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura university hospital

Al Mansurah, Dakahlia Governorate, Egypt

Location

Study Officials

  • Sameh Emile, M.D

    Mansoura University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of general surgery

Study Record Dates

First Submitted

October 28, 2015

First Posted

November 10, 2015

Study Start

January 1, 2012

Primary Completion

January 1, 2014

Study Completion

December 1, 2015

Last Updated

March 16, 2016

Record last verified: 2015-11

Locations

EG(1)