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

Rectal Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03026738
• Other study ID #: AssiutU4988
• Status: Not yet recruiting
• Phase: N/A
• First received: January 14, 2017
• Last updated: January 19, 2017
• Start date: January 2017
• Est. completion date: December 2019

Study information

• Verified date: January 2017
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• all patients with rectal prolapse either external or internal prolapse

Exclusion Criteria:

• Age below 18 years.

• Pregnancy or breast-feeding.

• Recurrence of rectal prolapse.

• patients with previous complicated abdominal surgery.

Related Conditions & MeSH terms

• Prolapse
• Rectal Prolapse

Intervention

Procedure:
• Laparoscopic anterior mesh rectopexy
fixation of the rectum anteriorly using laparosopy and polypropylene mesh
• Laparoscopic posterior mesh rectopexy
fixation of the rectum posteriorly using laparosopy and polypropylene mesh

Device:
• polypropylene mesh
A strip of polypropylene mesh will be introduced and sutured.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improvement of incontinence and / or constipation.		1 year postoperatively
Primary	recurrence rate		1 year postoperatively
Secondary	Duration of Surgery	The duration of the procedure will be registered in minutes.	intraoperative
Secondary	Peri-operative blood loss	Blood loss will be measured in milliliters	during surgery, 1 day