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

NCT01595412 | Terminated DMC

• 1 other identifier: NTR2743
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 6

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.

Conditions

Rectal Prolapse; Procidentia

Keywords

Laparoscopic surgery; Colorectal Surgery; Quality of Life; Rectal Prolapse; Anorectal Physiology

Outcome Measures

Primary Outcomes (1)

• 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.

  24 months

Secondary Outcomes (1)

• Optimal surgery and functional results

  24 months

Study Arms (2)

Cohort 2

ACTIVE COMPARATOR

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

Cohort 1

ACTIVE COMPARATOR

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

Interventions

Laparoscopic Resection Rectopexy PROCEDURE

laparoscopic sigmoidectomy with suture rectopexy

Also known as: Laparoscopic Resection Rectopexy,

Cohort 2

Laparoscopic Ventral Rectopexy PROCEDURE

laparoscopic ventral rectopexy with mesh

Also known as: Laparoscopic ventral mesh rectopexy, Ventral mesh rectopexy

Cohort 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients with an indication for Laparoscopic Resection Rectopexy\* for External Rectal Prolapse (Oxford Grade V)

You may not qualify if:

• Under 18 years of age
• Former rectosigmoid resection
• Former rectal prolapse surgery
• Rectosigmoid tumor
• Severe mental retardation
• Pregnant women

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (6)

The Florida Hospital

Orlando, Florida, 32806, United States

Location

Tampa General Hospital

Tampa, Florida, 33601, United States

Location

Cleveland Clinic Floria

Weston, Florida, 33331, United States

Location

Oschner Clinic North Shore

New Orleans, Louisiana, 70448, United States

Location

John Hopkins

Baltimore, Maryland, 21287, United States

Location

Lahey Medical Center

Burlington, Massachusetts, 01860, United States

Location

MeSH Terms

Conditions

Rectal Prolapse; Prolapse

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pelvic Organ Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Steven D Wexner, MD

  Cleveland Clinic Floria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2012
• First Posted: May 10, 2012
• Study Start: January 1, 2010
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: October 24, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)