Skip to main content
OpenTrials
Completed

NCT Number: NCT01980043

Endoluminal and Needlescopic Assisted Repair of Rectal Prolapse

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

75 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Weill Cornell Medical Center- NYPH

New York, 10065, United States

About this study

.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

  • Feasibility: successful completion of endoluminal rectal prolapse repair with needlescopic assistance
  • Safety: measured by the incidence of the Intraoperative complications (bowel perforation, organ injury and bleeding requiring blood transfusion)
  • Sedation and local anesthesia feasibility: surgery completed without patient intubation
  • Clinical Outcomes: rectal prolapse recurrence within 30 days, length of hospital stay and postsurgical complications
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

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

Treatment and study plan

endoluminal rectal prolapse repair under sedation

Procedure

endoluminal rectal prolapse repair under sedation

Primary outcomes

  1. rectal prolapse recurrence

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • Olympus

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Nov 8, 2013
Registry last updated
Jul 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.