Trial record 2 of 8 for:    Open Studies | "Rectal Prolapse"

Endoluminal and Needlescopic Assisted Repair of Rectal Prolapse

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by Weill Medical College of Cornell University
Sponsor:
Collaborator:
Olympus
Information provided by (Responsible Party):
Jeffrey W. Milsom, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01980043
First received: November 1, 2013
Last updated: December 4, 2015
Last verified: December 2015
  Purpose
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 Intervention
Rectal Prolapse
Procedure: endoluminal rectal prolapse repair under sedation

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Endoluminal and Needlescopic Assisted Repair of Rectal Prolapse With Abdominal Fixation Under Sedation and Local Anesthesia

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • rectal prolapse recurrence [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: February 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   75 Years to 100 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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 
Study First Received: November 1, 2013
Last Updated: December 4, 2015
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on February 11, 2016