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

Rectal Prolapse Clinical Trial

— LaProS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01595412
• Other study ID #: NTR2743
• Status: Terminated
• Phase: N/A
• First received: May 8, 2012
• Last updated: October 20, 2017
• Start date: January 2010
• Est. completion date: October 2017

Study information

• Verified date: October 2017
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Procidentia
• Prolapse
• Rectal Prolapse

Intervention

Procedure:
• Laparoscopic Resection Rectopexy
laparoscopic sigmoidectomy with suture rectopexy
• Laparoscopic Ventral Rectopexy
laparoscopic ventral rectopexy with mesh

Locations

Country	Name	City	State
United States	John Hopkins	Baltimore	Maryland
United States	Lahey Medical Center	Burlington	Massachusetts
United States	Oschner Clinic North Shore	New Orleans	Louisiana
United States	The Florida Hospital	Orlando	Florida
United States	Tampa General Hospital	Tampa	Florida
United States	Cleveland Clinic Floria	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life	Quality of Life objectified by the gastro-Intestinal Quality of Life Index and secondary by EuroQoL-5D and Short-Form 36 questionnaires.	24 months
Secondary	Optimal surgery and functional results	Compare 2 laparoscopic approaches and functional results evaluated by questionnaires	24 months

External Links

•   Dutch Trial Register