ClinicalTrials.gg
CompletedNCT02601326Updated Mar 16, 2016

Laparoscopic Ventral Mesh Rectopexy Versus Delorme's Operation in Management of Complete Rectal Prolapse

An interventional study of Laparoscopic ventral mesh Rectopexy and Delorme's procedure in Complete Rectal Prolapse, sponsored by Mansoura University. Completed at 1 site in Egypt. Open to participants aged 16 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-03-16.

Sponsored by Mansoura University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
16 Years to 70 Years
Sex
All
01

Study 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

Read the detailed description

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.

Follow up is scheduled for 18 months to evaluate recurrence, continence state and complications

02

Conditions studied

  • Complete Rectal Prolapse

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03

In context

Rectal Prolapse

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

This study's enrollment of 50 is close to the median of 55 across 34 interventional studies indexed under Rectal Prolapse.

Browse Rectal Prolapse studies →

Lead sponsor

Mansoura University is the lead sponsor of 1,119 studies on the registry; 183 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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

04

Who can participate

Ages eligible
16 Years to 70 Years
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

  • patients with complete rectal prolapse

Exclusion criteria

Exclusion Criteria:

  • patients who underwent previous surgery for complete rectal prolapse
  • patients unfit for surgery
  • patients with associated colorectal diseases or pathology
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Active comparator
    Laparoscopic ventral mesh Rectopexy

    Fixation of the rectum to the sacrum using laparoscopy and mesh

    Procedure: Laparoscopic ventral mesh Rectopexy

  • Active comparator
    delorme's procedure

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

    Procedure: Delorme's procedure

Interventions

  • ProcedureLaparoscopic ventral mesh Rectopexy

    Laparoscopic fixation of rectum to sacral promontory using mesh

  • ProcedureDelorme's procedure

    Transanal excision of rectal mucosa and plication of muscle layer

06

What researchers measure

Primary outcomes

  1. Recurrence of the condition

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

    Time frame: 18 month

07

Study locations

1 site
  • Mansoura university hospital
    Mansoura, Dakahlia, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2012, a primary completion of Jan 2014 and a completion of Dec 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 28, 2015
First posted
Nov 10, 2015
Start
Jan 2012
Primary completionActual
Jan 2014
CompletionActual
Dec 2015
Last update
Mar 16, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 16, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02601326
Responsible party
Sameh Emile (Lecturer of general surgery, Mansoura University) — Principal investigator
First posted
Nov 10, 2015
Start date
Jan 2012
Primary completion
Jan 2014
Completion
Dec 2015
Last update
Mar 16, 2016

Study contacts

Sameh Emile, M.D
principal investigator · Mansoura University

Oversight

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

Not currently enrolling

This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.

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