Endoluminal and Needlescopic Assisted Repair of Rectal Prolapse

Not Applicable

Completed

• Conditions: Rectal Prolapse
• Interventions: Procedure: endoluminal rectal prolapse repair under sedation

• Registration Number: NCT01980043
• Lead Sponsor: Weill Medical College of Cornell University

Brief Summary

The purpose of this study is to evaluate the safety and feasibility of endoluminal rectal prolapse repair under sedation and local anesthesia using CO2 colonoscopy to fix the rectum with sutures to the abdominal wall under needlescopic control. Further, investigators will evaluate the short and long-term clinical outcomes after this novel approach to treating rectal prolapse.

Detailed Description

.Aims/Objective The purpose of this study is to evaluate the safety and feasibility of endoluminal rectal prolapse repair under sedation and local anesthesia using CO2 colonoscopy to fix the rectum with sutures to the abdominal wall under needlescopic control. Further, we will evaluate the short and long-term clinical outcomes after this new procedure.

Primary Outcomes

1. Feasibility: successful completion of endoluminal rectal prolapse repair with needlescopic assistance

2. Safety: measured by the incidence of the Intraoperative complications (bowel perforation, organ injury and bleeding requiring blood transfusion)

3. Sedation and local anesthesia feasibility: surgery completed without patient intubation

4. Clinical Outcomes: rectal prolapse recurrence within 30 days, length of hospital stay and postsurgical complications

5. Long Term Clinical Outcomes: Rectal Prolapse Recurrence

Methods Design: A prospective pilot study with 10 patients who will be undergoing Combined Needlescopic and Endoluminal (Colonoscopic) Surgery under sedation and local anesthesia for Rectal Prolapse Repair with the Colon and Rectal Surgeons at WCMC. Data will be collected prospectively before, during, and after surgery.

Settings: Colon and Rectal Surgery at WCMC-NYPH Population: Patients male and female above 75 years of age, with rectal prolapse will be invited to participate in the study after surgery is deemed necessary for standard treatment of their medical conditions.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-05-20
• Study First Submitted: 2013-11-01
• Study First Submitted QC: 2013-11-01
• Study First Posted: 2013-11-08
• Primary Completion: 2018-03-22
• Study Completion: 2018-03-22
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-26
• Last Update Posted: 2019-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Age, 75 years and older, Male and Female
• BMI above 18 and ≤30
• ASA class 1-3
• willing to participate in the study

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Exclusion Criteria

• ASA class 4-5
• Previous Abdominal Surgeries including abdominal wall repair with mesh

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rectal Prolapse	endoluminal rectal prolapse repair under sedation	endoluminal rectal prolapse repair under sedation and local anesthesia using CO2 colonoscopy to fix the rectum with sutures to the abdominal wall under needlescopic control.

Primary Outcome Measures

Name	Time	Method
rectal prolapse recurrence	12 months

Trial Locations

Locations (1)

Weill Cornell Medical Center- NYPH; 🇺🇸 New York, New York, United States