Endoluminal and Needlescopic Assisted Repair of Rectal Prolapse

Sponsor
Weill Medical College of Cornell University (Other)
Overall Status
Completed
CT.gov ID
NCT01980043
Collaborator
Olympus (Industry)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: endoluminal rectal prolapse repair under sedation
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Endoluminal and Needlescopic Assisted Repair of Rectal Prolapse With Abdominal Fixation Under Sedation and Local Anesthesia
Actual Study Start Date :
May 20, 2013
Actual Primary Completion Date :
Mar 22, 2018
Actual Study Completion Date :
Mar 22, 2018

Arms and Interventions

Arm Intervention/Treatment
Other: Rectal Prolapse

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.

Procedure: endoluminal rectal prolapse repair under sedation
endoluminal rectal prolapse repair under sedation

Outcome Measures

Primary Outcome Measures

  1. rectal prolapse recurrence [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
75 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Weill Cornell Medical Center- NYPH New York New York United States 10065

Sponsors and Collaborators

  • Weill Medical College of Cornell University
  • Olympus

Investigators

  • Principal Investigator: Jeffrey W Milsom, MD, Weill Medical College of Cornell University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01980043
Other Study ID Numbers:
  • 1209013050
First Posted:
Nov 8, 2013
Last Update Posted:
Jul 30, 2019
Last Verified:
Jul 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 30, 2019