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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Cleveland Clinic Florida
Sponsor:
Information provided by (Responsible Party):
Steven Wexner, Cleveland Clinic Florida
ClinicalTrials.gov Identifier:
NCT01595412
First received: May 8, 2012
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Rectal Prolapse
Procidentia
Procedure: Laparoscopic Resection Rectopexy
Procedure: Laparoscopic Ventral Rectopexy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Cleveland Clinic Florida:

Primary Outcome Measures:
  • Quality of life [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Compare 2 laparoscopic approaches and functional results evaluated by questionnaires


Estimated Enrollment: 120
Study Start Date: April 2010
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01595412

Contacts
Contact: Jorge Canedo 954-659-5861 canedoj@ccf.org
Contact: Avery Gottfried, MHA 216-445-9440 gottfra@ccf.org

Locations
United States, Florida
The Florida Hospital Recruiting
Orlando, Florida, United States, 32806
Tampa General Hospital Recruiting
Tampa, Florida, United States, 33601
Cleveland Clinic Floria Recruiting
Weston, Florida, United States, 33331
Contact: Jorge Canedo    954-659-5861    canedoj@ccf.org   
Principal Investigator: Steven D Wexner, MD         
United States, Louisiana
Oschner Clinic North Shore Recruiting
New Orleans, Louisiana, United States, 70448
United States, Maryland
John Hopkins Not yet recruiting
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Lahey Medical Center Recruiting
Burlington, Massachusetts, United States, 01860
Sponsors and Collaborators
Cleveland Clinic Florida
Investigators
Principal Investigator: Steven D Wexner, MD Cleveland Clinic Floria
  More Information

Additional Information:
No publications provided

Responsible Party: Steven Wexner, Chief Academic Officer, Cleveland Clinic Florida
ClinicalTrials.gov Identifier: NCT01595412     History of Changes
Other Study ID Numbers: NTR2743
Study First Received: May 8, 2012
Last Updated: July 21, 2014
Health Authority: Netherlands: Independent Ethics Committee

Keywords provided by Cleveland Clinic Florida:
Laparoscopic surgery
Colorectal Surgery
Quality of Life
Rectal Prolapse
Anorectal Physiology

Additional relevant MeSH terms:
Prolapse
Rectal Prolapse
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Pathological Conditions, Anatomical
Pelvic Organ Prolapse
Rectal Diseases

ClinicalTrials.gov processed this record on October 21, 2014