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Laparoscopic Rectopexy for Rectal Prolapse

A

Aarhus University Hospital

Status

Completed

Conditions

Rectal Prolapse

Treatments

Procedure: Laparoscopic posterior rectopexy
Procedure: Laparoscopic anterior mesh rectopexy

Study type

Interventional

Funder types

Other

Identifiers

NCT00946205
Lap rectopexy 200660096

Details and patient eligibility

About

The aim of the present prospective, double-blind, randomized study is to study whether laparoscopic anterior mesh rectopexy is as good as laparoscopic posterior rectopexy with respect to obstructive defecation afterwards.

Full description

Full-thickness rectal prolapse is defined as a "falling down" of the rectum so that it is outside the body. Rectal prolapse can only be treated by surgery.

The choice of procedure depends on the patient's general condition and is based on a clinical judgment. Usually, elderly, high-risk patients are treated by perineal procedures. All other patients are offered an abdominal rectopexy using open or laparoscopic techniques. The general principle for all abdominal procedures is to induce adhesions between the mobilised, elevated rectum and the presacral fascia.

At least 30%-60% develop long-term complications: Obstructive defecation, which may be related to peroperative trauma to rectums innervation. Sparing of the lateral stalks during the rectal mobilisation results in lower frequency of obstructive defecation afterwards, but also higher recurrence rate.

A nerve-sparing laparoscopic technique for rectal prolapse has been developed in Belgium: Laparoscopic anterior mesh rectopexy.

After this procedure, the rate of obstructed defecations afterwards has been reported to less than 10%, that is, much lower than observed after other procedures.

The functional results after this nerve-sparing laparoscopic technique should be compared to those after laparoscopic posterior rectopexy, i.e. the conventional laparoscopic method.

Enrollment

75 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with full-thickness rectal prolapse for whom the department otherwise would offer abdominal rectopexy according to the department's recommendation. That is, patient being fit for an abdominal rectopexy procedure.

Exclusion criteria

  • Age below 18 years.
  • Pregnancy or breast-feeding.
  • Patients who do not speak or read Danish.
  • Dementia or other psychiatric disease, i.e., inability to give informed consent.
  • Recurrence of rectal prolapse.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

75 participants in 2 patient groups

Laparoscopic anterior mesh rectopexy
Experimental group
Treatment:
Procedure: Laparoscopic anterior mesh rectopexy
Laparoscopic posterior rectopexy
Active Comparator group
Treatment:
Procedure: Laparoscopic posterior rectopexy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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