Laparoscopic Rectopexy for Rectal Prolapse

NCT ID: NCT00946205

Last Updated: 2015-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2015-06-30

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.

Conditions

Rectal Prolapse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Laparoscopic anterior mesh rectopexy

Group Type: EXPERIMENTAL

Laparoscopic anterior mesh rectopexy

Intervention Type: PROCEDURE

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.

Laparoscopic posterior rectopexy

Group Type: ACTIVE_COMPARATOR

Laparoscopic posterior rectopexy

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aarhus University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lene H. Iversen

MD, DMSci, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Søren Laurberg, Professor

Role: STUDY_CHAIR

Aarhus University Hospital, Department of Surgery P

Locations

Aarhus University Hospital, Department of Surgery P

Aarhus, Aarhus C, Denmark

Countries

Denmark

References

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.

Reference Type: BACKGROUND

PMID: 15499644 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28404199 (View on PubMed)

Other Identifiers

Lap rectopexy 200660096

Identifier Type: -

Identifier Source: org_study_id