Endoluminal and Needlescopic Assisted Repair of Rectal Prolapse
|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|
- rectal prolapse recurrence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
|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)|
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
.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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01980043
|United States, New York|
|Weill Cornell Medical Center- NYPH||Recruiting|
|New York, New York, United States, 10065|
|Contact: Koiana Trencheva, RN,BSN,M.S firstname.lastname@example.org|
|Principal Investigator: Jeffrey W Milsom, MD|
|Principal Investigator:||Jeffrey W Milsom, MD||Weill Medical College of Cornell University|