An International Double Cohort Study to Compare Laparoscopic Ventral Rectopexy With Laparoscopic Resection Rectopexy

Not Applicable

Terminated

• Conditions: Procidentia; Rectal Prolapse
• Interventions: Procedure: Laparoscopic Ventral Rectopexy; Procedure: Laparoscopic Resection Rectopexy

• Registration Number: NCT01595412
• Lead Sponsor: The Cleveland Clinic

Brief Summary

Background:

Rectal prolapse (RP) is the descent of the upper rectum and is a common problem in the western world. Surgery is the only definite treatment and is preferably performed minimally invasive. High-level prospective studies on treatment strategies for RP currently are lacking and, thus, no consensus exist regarding the optimal treatment for patients with RP. Furthermore, remarkable transatlantic differences exist, as in Europe, laparoscopic ventral rectopexy (LVR) is regarded the treatment of choice, while in the USA Laparoscopic Resection Rectopexy (LRR) remains the golden standard.

Objective:

To determine the optimal minimally invasive surgical treatment for patients with RP.

Design:

International, prospective, comparative double cohort study. The first cohort will consist of 120 European patients with a RP and will be treated with LVR. Centres in The Netherlands, Belgium and the UK are enlisted for participation. The second cohort will consist of 120 American patients with a RP, treated with LRR. Several US centres are enlisted. Preoperative work-up consists of radiological imaging and standardised questionnaires. Follow-up (FU) is set on two years. During FU, pre-operative imaging and questionnaires will be repeated.

Primary \& secondary outcomes:

Primary endpoint will be improvement on the Gastro-Intestinal-Quality-of-Life-Index (GIQLI). Secondary endpoints will be generic Quality-of-Life, functional results, morbidity, mortality, recurrences and cost-effectiveness.

Time frame:

Study and inclusion start will be on January the 1st, 2011 and will take approximately 18-24 months. Therefore, total study duration will be 42-48 months.

Detailed Description

A Rectal Prolapse (RP), or procidentia, is the descent of the upper rectum. This descensus in the full-thickness of the rectum, and can be either internal, called an internal rectal prolapse or intussusception (IRP), or through the anus (called an external rectal prolapse (ERP)).

RP mainly occurs in women (80-90%) of which most in the 6-7th decade. Risk factors for developing a rectal prolapse are the presence of an abnormal deep pouch of Douglas, laxity and atonic condition of the muscles of the pelvic floor and anal canal. Moreover, weakness of both internal and external sphincters, often with evidence of pudendal nerve neuropathy and the lack of normal fixation of the rectum may lead to RP. This also frequently leads to other pelvic organ prolapses like vesicoceles, enteroceles and genital prolapses. In this study the investigators will focus on the treatment of RP.

Rectal prolapses cause anal incontinence in more than half of the patients. Another frequent symptom of RP is constipation. Furthermore, the rectal prolapse can lead to anal pain as a result of incarceration leading to ulcers, necrosis and perforation.

Besides the fact that this disease has a considerable impact on the individual quality of life, it also carries significant socio-economic consequences as incontinence products have to be used in large amounts.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2012-05-08
• Study First Submitted QC: 2012-05-09
• Study First Posted: 2012-05-10
• Status Verified: 2017-10
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Last Update Submitted: 2017-10-20
• Last Update Posted: 2017-10-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

• All patients with an indication for Laparoscopic Resection Rectopexy* for External Rectal Prolapse (Oxford Grade V)

Exclusion Criteria

• Under 18 years of age
• Former rectosigmoid resection
• Former rectal prolapse surgery
• Rectosigmoid tumor
• Severe mental retardation
• Pregnant women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1	Laparoscopic Ventral Rectopexy	Cohort one will consist of 120 patients with an external rectal prolapse (Oxford Grade V) which will be treated with Laparoscopic Ventral Rectopexy. As this is the standard treatment in the European centers involved in this study these patients will be selected in the participating centers in the Netherlands, Belgium and England.
Cohort 2	Laparoscopic Resection Rectopexy	Cohort 2 (two) will consist of 120 patients with an external rectal prolapse (Oxford Grade V)treated by Laparoscopic Resection Rectopexy (LRR). These patients will be included in the US centers involved in this study and treated by LRR.

Primary Outcome Measures

Name	Time	Method
Quality of life	24 months	Quality of Life objectified by the gastro-Intestinal Quality of Life Index and secondary by EuroQoL-5D and Short-Form 36 questionnaires.

Secondary Outcome Measures

Name	Time	Method
Optimal surgery and functional results	24 months	Compare 2 laparoscopic approaches and functional results evaluated by questionnaires

Trial Locations

Locations (6)

The Florida Hospital; 🇺🇸 Orlando, Florida, United States

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States

Cleveland Clinic Floria; 🇺🇸 Weston, Florida, United States

Oschner Clinic North Shore; 🇺🇸 New Orleans, Louisiana, United States

John Hopkins; 🇺🇸 Baltimore, Maryland, United States

Lahey Medical Center; 🇺🇸 Burlington, Massachusetts, United States