Laparoscopic Rectopexy for Rectal Prolapse
Information source: Aarhus University Hospital
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rectal Prolapse
Intervention: Laparoscopic posterior rectopexy (Procedure); Laparoscopic anterior mesh rectopexy (Procedure)
Phase: N/A
Status: Recruiting
Sponsored by: Aarhus University Hospital Official(s) and/or principal investigator(s):
Søren Laurberg, Professor, Study Chair, Affiliation: Aarhus University Hospital, Department of Surgery P
Summary
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.
Clinical Details
Official title: Laparoscopic Posterior Rectopexy Without Mesh vs. Laparoscopic Anterior Mesh Rectopexy for Rectal Prolapse - a Prospective, Double-blind, Randomised Study
Study design: Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment
Primary outcome: The severity of obstructive defecation as graded by Wexner's incontinence- and constipation-score and Obstructed Defecation Syndrome score
Secondary outcome: Physiologic testing of the ano-rectum: Anorectal manometry,anal sensibility,anal ultrasound, colonic transit.
Detailed 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Aarhus University Hospital, Department of Surgery P, Aarhus, Aarhus C DK-8000, Denmark; Recruiting
Lene H. Iversen, MD, PhD, Phone: +45 89 49 77 15, Email: lene.h.iversen@dadlnet.dk
Søren Laurberg, Professor, Phone: +45 89 49 77 15, Email: soerlaur@rm.dk
Lene H. Iversen, MD, PhD, Principal Investigator
Additional Information
Related publications: D'Hoore A, Cadoni R, Penninckx F. Long-term outcome of laparoscopic ventral rectopexy for total rectal prolapse. Br J Surg. 2004 Nov;91(11):1500-5.
Starting date: September 2006
Ending date: September 2012
Last updated: July 23, 2009
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