Laparoscopic Rectopexy for Rectal Prolapse

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Aarhus University Hospital
Sponsor:
Information provided by (Responsible Party):
Lene H. Iversen, Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT00946205
First received: July 22, 2009
Last updated: January 17, 2013
Last verified: January 2013

July 22, 2009
January 17, 2013
September 2006
June 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00946205 on ClinicalTrials.gov Archive Site
Physiologic testing of the ano-rectum: Anorectal manometry,anal sensibility,anal ultrasound, colonic transit. [ Time Frame: 1 year postoperatively ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Laparoscopic Rectopexy for Rectal Prolapse
Laparoscopic Posterior Rectopexy Without Mesh vs. Laparoscopic Anterior Mesh Rectopexy for Rectal Prolapse - a Prospective, Double-blind, Randomised Study

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-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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Rectal Prolapse
  • 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.
  • 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.
  • Experimental: Laparoscopic anterior mesh rectopexy
    Intervention: Procedure: Laparoscopic anterior mesh rectopexy
  • Active Comparator: Laparoscopic posterior rectopexy
    Intervention: Procedure: Laparoscopic posterior rectopexy
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
76
June 2015
June 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Denmark
 
NCT00946205
Lap rectopexy 200660096
No
Lene H. Iversen, Aarhus University Hospital
Aarhus University Hospital
Not Provided
Study Chair: Søren Laurberg, Professor Aarhus University Hospital, Department of Surgery P
Aarhus University Hospital
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP