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

Endoluminal and Needlescopic Assisted Repair of Rectal Prolapse With Abdominal Fixation Under Sedation and Local Anesthesia (no)

This study is currently recruiting participants.
Verified November 2013 by Weill Medical College of Cornell University
Sponsor:
Collaborator:
Olympus
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01980043
First received: November 1, 2013
Last updated: NA
Last verified: November 2013
History: No changes posted
  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, we 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 and local anesthesia

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 2015
Estimated Primary Completion Date: March 2015 (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 and local anesthesia
endoluminal rectal prolapse repair under sedation and local anesthesia

  Eligibility

Ages Eligible for Study:   75 Years and older
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
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: 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: November 1, 2013
Health Authority: United States: Weill Cornell Medical College

Additional relevant MeSH terms:
Rectal Prolapse
Prolapse
Pathological Conditions, Anatomical
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pelvic Organ Prolapse
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014