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

Rectal Prolapse Clinical Trial

Official title: Laparoscopic Rectal Prolapse Surgery Study. An International, Double Cohort Study to Determine the Optimal Treatment for Rectal Prolapse.

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Procidentia
• Prolapse
• Rectal Prolapse

• NCT number: NCT01595412
• Study type: Interventional
• Source: The Cleveland Clinic
• Status: Terminated
• Phase: N/A
• Start date: January 2010
• Completion date: October 2017