Endoluminal and Needlescopic Assisted Repair of Rectal Prolapse
Primary Purpose
Rectal Prolapse
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
endoluminal rectal prolapse repair under sedation
Sponsored by
About this trial
This is an interventional treatment trial for Rectal Prolapse
Eligibility Criteria
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
Sites / Locations
- Weill Cornell Medical Center- NYPH
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Rectal Prolapse
Arm Description
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.
Outcomes
Primary Outcome Measures
rectal prolapse recurrence
Secondary Outcome Measures
Full Information
NCT ID
NCT01980043
First Posted
November 1, 2013
Last Updated
July 26, 2019
Sponsor
Weill Medical College of Cornell University
Collaborators
Olympus
1. Study Identification
Unique Protocol Identification Number
NCT01980043
Brief Title
Endoluminal and Needlescopic Assisted Repair of Rectal Prolapse
Official Title
Endoluminal and Needlescopic Assisted Repair of Rectal Prolapse With Abdominal Fixation Under Sedation and Local Anesthesia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
May 20, 2013 (Actual)
Primary Completion Date
March 22, 2018 (Actual)
Study Completion Date
March 22, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
Olympus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Prolapse
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rectal Prolapse
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
endoluminal rectal prolapse repair under sedation
Intervention Description
endoluminal rectal prolapse repair under sedation
Primary Outcome Measure Information:
Title
rectal prolapse recurrence
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
75 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey W Milsom, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medical Center- NYPH
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33090077
Citation
Milsom JW, Trencheva K, Gadalla F, Abramovitz S, Garrett KA. Rectal Prolapse Repair with Abdominal Fixation Under Sedation and Local or Epidural Anesthesia: Prospective Pilot Study in 10 Elderly Subjects. J Laparoendosc Adv Surg Tech A. 2021 Aug;31(8):911-916. doi: 10.1089/lap.2019.0804. Epub 2020 Oct 21.
Results Reference
derived
Learn more about this trial
Endoluminal and Needlescopic Assisted Repair of Rectal Prolapse
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