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Endoluminal and Needlescopic Assisted Repair of Rectal Prolapse

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ClinicalTrials.gov Identifier: NCT01980043
Recruitment Status : Recruiting
First Posted : November 8, 2013
Last Update Posted : July 12, 2017
Sponsor:
Collaborator:
Olympus
Information provided by (Responsible Party):
Jeffrey W. Milsom, 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.

Condition or disease Intervention/treatment
Rectal Prolapse Procedure: endoluminal rectal prolapse repair under sedation

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
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
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. rectal prolapse recurrence [ Time Frame: 12 months ]


Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01980043


Locations
United States, New York
Weill Cornell Medical Center- NYPH Recruiting
New York, New York, United States, 10065
Contact: Koiana Trencheva, RN,BSN,M.S       kivanova@med.cornell.edu   
Principal Investigator: Jeffrey W Milsom, MD         
Sponsors and Collaborators
Weill Medical College of Cornell University
Olympus
Investigators
Principal Investigator: Jeffrey W Milsom, MD Weill Medical College of Cornell University

Responsible Party: Jeffrey W. Milsom, Professor of Colon and Rectal Surgery, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01980043     History of Changes
Other Study ID Numbers: 1209013050
First Posted: November 8, 2013    Key Record Dates
Last Update Posted: July 12, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Prolapse
Rectal Prolapse
Pathological Conditions, Anatomical
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pelvic Organ Prolapse