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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01595412
Recruitment Status : Terminated (2 patients enrolled lost of follow-up after completing 1st year visits.PI decided to close)
First Posted : May 10, 2012
Last Update Posted : October 24, 2017
Information provided by (Responsible Party):
The Cleveland Clinic

Brief Summary:


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.


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


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.

Condition or disease Intervention/treatment Phase
Rectal Prolapse Procidentia Procedure: Laparoscopic Resection Rectopexy Procedure: Laparoscopic Ventral Rectopexy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Laparoscopic Rectal Prolapse Surgery Study. An International, Double Cohort Study to Determine the Optimal Treatment for Rectal Prolapse.
Actual Study Start Date : January 2010
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 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.
Procedure: Laparoscopic Resection Rectopexy
laparoscopic sigmoidectomy with suture rectopexy
Other Name: Laparoscopic Resection Rectopexy,

Active Comparator: 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.
Procedure: Laparoscopic Ventral Rectopexy
laparoscopic ventral rectopexy with mesh
Other Names:
  • Laparoscopic ventral mesh rectopexy
  • Ventral mesh rectopexy

Primary Outcome Measures :
  1. Quality of life [ Time Frame: 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 :
  1. Optimal surgery and functional results [ Time Frame: 24 months ]
    Compare 2 laparoscopic approaches and functional results evaluated by questionnaires

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01595412

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United States, Florida
The Florida Hospital
Orlando, Florida, United States, 32806
Tampa General Hospital
Tampa, Florida, United States, 33601
Cleveland Clinic Floria
Weston, Florida, United States, 33331
United States, Louisiana
Oschner Clinic North Shore
New Orleans, Louisiana, United States, 70448
United States, Maryland
John Hopkins
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Lahey Medical Center
Burlington, Massachusetts, United States, 01860
Sponsors and Collaborators
The Cleveland Clinic
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Principal Investigator: Steven D Wexner, MD Cleveland Clinic Floria
Additional Information:
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Responsible Party: The Cleveland Clinic Identifier: NCT01595412    
Other Study ID Numbers: NTR2743
First Posted: May 10, 2012    Key Record Dates
Last Update Posted: October 24, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by The Cleveland Clinic:
Laparoscopic surgery
Colorectal Surgery
Quality of Life
Rectal Prolapse
Anorectal Physiology
Additional relevant MeSH terms:
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Rectal Prolapse
Pathological Conditions, Anatomical
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pelvic Organ Prolapse