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

Status:	Terminated
Conditions:	Gastrointestinal
Therapuetic Areas:	Gastroenterology
Healthy:	No
Age Range:	18 - Any
Updated:	10/26/2017
Start Date:	January 2010
End Date:	October 2017

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

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.

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.

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

We found this trial at

sites

John Hopkins

Baltimore, Maryland 21287

from

Baltimore, MD