An International Double Cohort Study to Compare Laparoscopic Ventral Rectopexy With Laparoscopic Resection Rectopexy
NCT ID: NCT01595412
Last Updated: 2017-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
2 participants
INTERVENTIONAL
2010-01-31
2017-10-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 2
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.
Laparoscopic Resection Rectopexy
laparoscopic sigmoidectomy with suture rectopexy
Cohort 1
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.
Laparoscopic Ventral Rectopexy
laparoscopic ventral rectopexy with mesh
Interventions
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Laparoscopic Resection Rectopexy
laparoscopic sigmoidectomy with suture rectopexy
Laparoscopic Ventral Rectopexy
laparoscopic ventral rectopexy with mesh
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Former rectosigmoid resection
* Former rectal prolapse surgery
* Rectosigmoid tumor
* Severe mental retardation
* Pregnant women
18 Years
ALL
No
Sponsors
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The Cleveland Clinic
OTHER
Responsible Party
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Principal Investigators
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Steven D Wexner, MD
Role: PRINCIPAL_INVESTIGATOR
Cleveland Clinic Floria
Locations
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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
Countries
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Other Identifiers
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NTR2743
Identifier Type: -
Identifier Source: org_study_id