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

Primary Purpose

Rectal Prolapse, Procidentia

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Laparoscopic Resection Rectopexy
Laparoscopic Ventral Rectopexy
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Prolapse focused on measuring Laparoscopic surgery, Colorectal Surgery, Quality of Life, Rectal Prolapse, Anorectal Physiology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Florida Hospital
  • Tampa General Hospital
  • Cleveland Clinic Floria
  • Oschner Clinic North Shore
  • John Hopkins
  • Lahey Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Cohort 2

Cohort 1

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Optimal surgery and functional results
Compare 2 laparoscopic approaches and functional results evaluated by questionnaires

Full Information

First Posted
May 8, 2012
Last Updated
October 20, 2017
Sponsor
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT01595412
Brief Title
An International Double Cohort Study to Compare Laparoscopic Ventral Rectopexy With Laparoscopic Resection Rectopexy
Acronym
LaProS
Official Title
Laparoscopic Rectal Prolapse Surgery Study. An International, Double Cohort Study to Determine the Optimal Treatment for Rectal Prolapse.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Terminated
Why Stopped
2 patients enrolled lost of follow-up after completing 1st year visits.PI decided to close
Study Start Date
January 2010 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Prolapse, Procidentia
Keywords
Laparoscopic surgery, Colorectal Surgery, Quality of Life, Rectal Prolapse, Anorectal Physiology

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 2
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Cohort 1
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic Resection Rectopexy
Other Intervention Name(s)
Laparoscopic Resection Rectopexy,
Intervention Description
laparoscopic sigmoidectomy with suture rectopexy
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic Ventral Rectopexy
Other Intervention Name(s)
Laparoscopic ventral mesh rectopexy, Ventral mesh rectopexy
Intervention Description
laparoscopic ventral rectopexy with mesh
Primary Outcome Measure Information:
Title
Quality of life
Description
Quality of Life objectified by the gastro-Intestinal Quality of Life Index and secondary by EuroQoL-5D and Short-Form 36 questionnaires.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Optimal surgery and functional results
Description
Compare 2 laparoscopic approaches and functional results evaluated by questionnaires
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven D Wexner, MD
Organizational Affiliation
Cleveland Clinic Floria
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Florida Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33601
Country
United States
Facility Name
Cleveland Clinic Floria
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Facility Name
Oschner Clinic North Shore
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70448
Country
United States
Facility Name
John Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Lahey Medical Center
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01860
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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