Laparoscopic Rectopexy for Rectal Prolapse - Full Text View

Sponsor:	Aarhus University Hospital
Information provided by:	Aarhus University Hospital
ClinicalTrials.gov Identifier:	NCT00946205

Purpose

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.

Condition	Intervention
Rectal Prolapse	Procedure: Laparoscopic posterior rectopexy Procedure: Laparoscopic anterior mesh rectopexy

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Laparoscopic Posterior Rectopexy Without Mesh vs. Laparoscopic Anterior Mesh Rectopexy for Rectal Prolapse - a Prospective, Double-blind, Randomised Study

Resource links provided by NLM:

MedlinePlus related topics: Bowel Movement Pelvic Support Problems

U.S. FDA Resources

Further study details as provided by Aarhus University Hospital:

Primary Outcome Measures:

The severity of obstructive defecation as graded by Wexner's incontinence- and constipation-score and Obstructed Defecation Syndrome score [ Time Frame: 1 year postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Physiologic testing of the ano-rectum: Anorectal manometry,anal sensibility,anal ultrasound, colonic transit. [ Time Frame: 1 year postoperatively ] [ Designated as safety issue: No ]

Estimated Enrollment:	64
Study Start Date:	September 2006
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Laparoscopic anterior mesh rectopexy	Procedure: Laparoscopic anterior mesh rectopexy The peritoneum is incised over the right side of the promontory. The incision is extended in an inverted J-form along the right side of rectum and over the deepest part of the pouch of Douglas. Denonvilliers fascia is incised and the rectovaginal (women)/rectovesical (men) septum is broadly opened. A prosthetic mesh (3 x 17 cm) is sutured with nonabsorbable sutures to the ventral aspect of the rectum in the rectovaginal/rectovesical septum and to the lateral seromuscular borders of rectum and fixed upon the promontory using a stapler. The posterior fornix of vagina (women)/floor of the bladder (men) is elevated and sutured to the anterior aspect of the mesh. The incised peritoneum is then closed over the mesh.
Active Comparator: Laparoscopic posterior rectopexy	Procedure: Laparoscopic posterior rectopexy The rectum is mobilised down to the os coccygeus, then it is elevated cephalic and sutured with a multifilament suture to the presacral fascia just below the sacral promontory. The lateral stalks should be left intact.

Arms

Assigned Interventions

Experimental: Laparoscopic anterior mesh rectopexy

Procedure: Laparoscopic anterior mesh rectopexy

The peritoneum is incised over the right side of the promontory. The incision is extended in an inverted J-form along the right side of rectum and over the deepest part of the pouch of Douglas. Denonvilliers fascia is incised and the rectovaginal (women)/rectovesical (men) septum is broadly opened. A prosthetic mesh (3 x 17 cm) is sutured with nonabsorbable sutures to the ventral aspect of the rectum in the rectovaginal/rectovesical septum and to the lateral seromuscular borders of rectum and fixed upon the promontory using a stapler. The posterior fornix of vagina (women)/floor of the bladder (men) is elevated and sutured to the anterior aspect of the mesh. The incised peritoneum is then closed over the mesh.

Active Comparator: Laparoscopic posterior rectopexy

Procedure: Laparoscopic posterior rectopexy

The rectum is mobilised down to the os coccygeus, then it is elevated cephalic and sutured with a multifilament suture to the presacral fascia just below the sacral promontory. The lateral stalks should be left intact.

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00946205

Locations

Denmark
Aarhus University Hospital, Department of Surgery P	Recruiting
Aarhus, Aarhus C, Denmark, DK-8000
Contact: Lene H. Iversen, MD, PhD +45 89 49 77 15 lene.h.iversen@dadlnet.dk
Contact: Søren Laurberg, Professor +45 89 49 77 15 soerlaur@rm.dk
Principal Investigator: Lene H. Iversen, MD, PhD

Sponsors and Collaborators

Aarhus University Hospital

Investigators

Study Chair:

Søren Laurberg, Professor

Aarhus University Hospital, Department of Surgery P

More Information

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.

Responsible Party:	Lene Hjerrild Iversen, MD, PhD, Aarhus University Hospital, Department of Surgery P
ClinicalTrials.gov Identifier:	NCT00946205 History of Changes
Other Study ID Numbers:	Lap rectopexy 200660096
Study First Received:	July 22, 2009
Last Updated:	June 27, 2011
Health Authority:	Denmark: Ethics Committee

Keywords provided by Aarhus University Hospital:

rectal prolapse
laparoscopic rectopexy
obstructed defecation

Additional relevant MeSH terms:

Prolapse
Rectal Prolapse
Pathological Conditions, Anatomical
Rectal Diseases

Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pelvic Organ Prolapse

ClinicalTrials.gov processed this record on February 09, 2012