Laparoscopic Rectopexy for Rectal Prolapse
Primary Purpose
Rectal Prolapse
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Laparoscopic posterior rectopexy
Laparoscopic anterior mesh rectopexy
Sponsored by
About this trial
This is an interventional treatment trial for Rectal Prolapse focused on measuring rectal prolapse, laparoscopic rectopexy, obstructed defecation
Eligibility 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.
Sites / Locations
- Aarhus University Hospital, Department of Surgery P
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Laparoscopic anterior mesh rectopexy
Laparoscopic posterior rectopexy
Arm Description
Outcomes
Primary Outcome Measures
The severity of obstructive defecation as graded by Wexner's incontinence- and constipation-score and Obstructed Defecation Syndrome score
Secondary Outcome Measures
Physiologic testing of the ano-rectum: Anorectal manometry,anal sensibility,anal ultrasound, colonic transit.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00946205
Brief Title
Laparoscopic Rectopexy for Rectal Prolapse
Official Title
Laparoscopic Posterior Rectopexy Without Mesh vs. Laparoscopic Anterior Mesh Rectopexy for Rectal Prolapse - a Prospective, Double-blind, Randomised Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aarhus University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Prolapse
Keywords
rectal prolapse, laparoscopic rectopexy, obstructed defecation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Laparoscopic anterior mesh rectopexy
Arm Type
Experimental
Arm Title
Laparoscopic posterior rectopexy
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic posterior rectopexy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic anterior mesh rectopexy
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Physiologic testing of the ano-rectum: Anorectal manometry,anal sensibility,anal ultrasound, colonic transit.
Time Frame
1 year postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Søren Laurberg, Professor
Organizational Affiliation
Aarhus University Hospital, Department of Surgery P
Official's Role
Study Chair
Facility Information:
Facility Name
Aarhus University Hospital, Department of Surgery P
City
Aarhus
State/Province
Aarhus C
ZIP/Postal Code
DK-8000
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
15499644
Citation
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. doi: 10.1002/bjs.4779.
Results Reference
background
PubMed Identifier
28404199
Citation
Lundby L, Iversen LH, Buntzen S, Wara P, Hoyer K, Laurberg S. Bowel function after laparoscopic posterior sutured rectopexy versus ventral mesh rectopexy for rectal prolapse: a double-blind, randomised single-centre study. Lancet Gastroenterol Hepatol. 2016 Dec;1(4):291-297. doi: 10.1016/S2468-1253(16)30085-1. Epub 2016 Oct 4.
Results Reference
derived
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Laparoscopic Rectopexy for Rectal Prolapse
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