ClinicalTrials.gg
Status unknownNCT03026738Updated Jan 20, 2017

Anterior Versus Posterior Laparoscopic Mesh Rectopexy For Rectal Prolapse; a Randomized Controlled Trial.

An interventional study of Laparoscopic anterior mesh rectopexy and Laparoscopic posterior mesh rectopexy in Rectal Prolapse, sponsored by Assiut University. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-20.

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

The sponsor has not verified this record recently (last verified Jan 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Aim of this work is to compare results between Laparoscopic Anterior Mesh Rectopexy and Laparoscopic Posterior Mesh Rectopexy for patients with rectal prolapse by assessment of operative time, intraoperative blood loss , intraoperative organ injury, overall length of hospital stay, recurrence,and improvement of incontinence and constipation.

Read the detailed description

Rectal prolapse is a disabling condition, which is more common in females and increases in frequency with age.

There are two types of rectal prolapse; external and internal. External rectal prolapse is a circumferential protrusion of all layers of the rectum through the anal sphincter. Internal rectal prolapse, also referred to as rectal intussusception.

The majority of patients with a RP suffer from symptoms of fecal incontinence and constipation, causing a significant negative impact on quality of life.

The aims of the surgical treatment are to correct the anatomical abnormality and to cure the accompanying symptoms of incontinence, constipation and pain, with the lowest rate of complications as possible and an acceptable rate of recurrence.

Since the emergence of minimally invasive surgery, laparoscopic techniques for the treatment for RP have been applied in patients of all ages.

02

Conditions studied

  • 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 planned enrollment of 30 is below the median of 55 across 34 interventional studies indexed under Rectal Prolapse.

Browse Rectal Prolapse studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 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
18 Years and older
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 with rectal prolapse either external or internal prolapse

Exclusion criteria

Exclusion Criteria:

  • Age below 18 years.
  • Pregnancy or breast-feeding.
  • Recurrence of rectal prolapse.
  • patients with previous complicated abdominal surgery.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Laparoscopic anterior mesh rectopexy

    A superficial peritoneal window will be made over the right part of the sacral promontory and extended caudally over the right outer border of the mesorectum down to the right side of the pouch of Douglas. In females, the vagina will be retracted anteriorly and a careful dissection of the rectovaginal septum will be performed down to the pelvic floor. A strip of polypropylene (3×20 cm) mesh will be introduced and sutured as distally as possible on the anterior rectal wall/ perineal body with three, interrupted nonabsorbable sutures.The posterior wall of the vagina will be fixed to the mesh using absorbable sutures. The mesh is then secured tension-free to the sacral promontory using three absorbable sutures. The mesh will be peritonealized by suturing the free edges of the previously divided peritoneum over the mesh to provide additional ventral elevation of the enterocele and avoid small bowel adhesions to the mesh.

    Procedure: Laparoscopic anterior mesh rectopexy · Device: polypropylene mesh

  • Active comparator
    Laparoscopic posterior mesh rectopexy

    Mobilization of the mesorectum posteriorly from the sacral promontory to the pelvic floor. Lateral stalks will not be divided. Bowel resection and circumferential division of the peritoneum will not be done in this study. A T-shaped polypropylene mesh will be placed with the vertical "leg" laying flush with the anterior surface of the sacrum, and secured to the promontory and sacrum with three absorbable sutures. The mesh "wings" will be sutured to the lateral sides of the rectum/mesorectum with two absorbable sutures on each side. The visceral peritoneum will be left open.

    Procedure: Laparoscopic posterior mesh rectopexy · Device: polypropylene mesh

Interventions

  • ProcedureLaparoscopic anterior mesh rectopexy

    fixation of the rectum anteriorly using laparosopy and polypropylene mesh

  • ProcedureLaparoscopic posterior mesh rectopexy

    fixation of the rectum posteriorly using laparosopy and polypropylene mesh

  • Devicepolypropylene mesh

    A strip of polypropylene mesh will be introduced and sutured.

06

What researchers measure

Primary outcomes

  1. improvement of incontinence and / or constipation.

    Time frame: 1 year postoperatively

  2. recurrence rate

    Time frame: 1 year postoperatively

Secondary outcomes

  1. Duration of Surgery

    The duration of the procedure will be registered in minutes.

    Time frame: intraoperative

  2. Peri-operative blood loss

    Blood loss will be measured in milliliters

    Time frame: during surgery, 1 day

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Study locations

No study locations are listed for this record.

08

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 Jan 20, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03026738
Lead sponsor
Assiut University
Responsible party
Ibrahim Mostafa Ahmed Abdel Aal (Assistant lecturer, Assiut University) — Principal investigator
First posted
Jan 20, 2017
Start date
Jan 2017
Primary completion
Dec 2018 (estimated)
Completion
Dec 2019 (estimated)
Last update
Jan 20, 2017

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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