NCT01980043

Endoluminal and Needlescopic Assisted Repair of Rectal Prolapse

Endoluminal and Needlescopic Assisted Repair of Rectal Prolapse With Abdominal Fixation Under Sedation and Local Anesthesia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 75 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rectal Prolapse

Interventions

Type	Name	Description
PROCEDURE	endoluminal rectal prolapse repair under sedation	endoluminal rectal prolapse repair under sedation

Timeline

• Start date: 2013-05-20
• Primary completion: 2018-03-22
• Completion: 2018-03-22
• First posted: 2013-11-08
• Last updated: 2019-07-30

Locations

1 site across 1 country: United States