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Laparoscopic Rectopexy for Rectal Prolapse

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00946205
Recruitment Status : Completed
First Posted : July 24, 2009
Last Update Posted : July 9, 2015
Information provided by (Responsible Party):
Lene H. Iversen, Aarhus University Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Rectal Prolapse Procedure: Laparoscopic posterior rectopexy Procedure: Laparoscopic anterior mesh rectopexy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : September 2006
Actual Primary Completion Date : February 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. The severity of obstructive defecation as graded by Wexner's incontinence- and constipation-score and Obstructed Defecation Syndrome score [ Time Frame: 1 year postoperatively ]

Secondary Outcome Measures :
  1. Physiologic testing of the ano-rectum: Anorectal manometry,anal sensibility,anal ultrasound, colonic transit. [ Time Frame: 1 year postoperatively ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00946205

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Aarhus University Hospital, Department of Surgery P
Aarhus, Aarhus C, Denmark, DK-8000
Sponsors and Collaborators
Aarhus University Hospital
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Study Chair: Søren Laurberg, Professor Aarhus University Hospital, Department of Surgery P
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Lene H. Iversen, MD, DMSci, PhD, Aarhus University Hospital Identifier: NCT00946205    
Other Study ID Numbers: Lap rectopexy 200660096
First Posted: July 24, 2009    Key Record Dates
Last Update Posted: July 9, 2015
Last Verified: July 2015
Keywords provided by Lene H. Iversen, Aarhus University Hospital:
rectal prolapse
laparoscopic rectopexy
obstructed defecation
Additional relevant MeSH terms:
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Rectal Prolapse
Pathological Conditions, Anatomical
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pelvic Organ Prolapse