NCT00946205

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

July 22, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 24, 2009

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

July 9, 2015

Status Verified

July 1, 2015

Enrollment Period

8.4 years

First QC Date

July 22, 2009

Last Update Submit

July 8, 2015

Conditions

Rectal Prolapse

Keywords

rectal prolapselaparoscopic rectopexyobstructed defecation

Outcome Measures

Primary Outcomes (1)

  • The severity of obstructive defecation as graded by Wexner's incontinence- and constipation-score and Obstructed Defecation Syndrome score

    1 year postoperatively

Secondary Outcomes (1)

  • Physiologic testing of the ano-rectum: Anorectal manometry,anal sensibility,anal ultrasound, colonic transit.

    1 year postoperatively

Study Arms (2)

Laparoscopic anterior mesh rectopexy

EXPERIMENTAL
Procedure: Laparoscopic anterior mesh rectopexy

Laparoscopic posterior rectopexy

ACTIVE COMPARATOR
Procedure: Laparoscopic posterior rectopexy

Interventions

Laparoscopic posterior rectopexyPROCEDURE

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.

Laparoscopic posterior rectopexy
Laparoscopic anterior mesh rectopexyPROCEDURE

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 anterior mesh rectopexy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital, Department of Surgery P

Aarhus, Aarhus C, DK-8000, Denmark

Location

Related Publications (2)

  • 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.

    PMID: 15499644BACKGROUND

  • 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.

    PMID: 28404199DERIVED

MeSH Terms

Conditions

Rectal Prolapse

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesPelvic Organ ProlapseProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Søren Laurberg, Professor

    Aarhus University Hospital, Department of Surgery P

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, DMSci, PhD

Study Record Dates

First Submitted

July 22, 2009

First Posted

July 24, 2009

Study Start

September 1, 2006

Primary Completion

February 1, 2015

Study Completion

June 1, 2015

Last Updated

July 9, 2015

Record last verified: 2015-07

Locations

DK(1)