Endoluminal and Needlescopic Assisted Repair of Rectal Prolapse
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|ClinicalTrials.gov Identifier: NCT01980043|
Recruitment Status : Completed
First Posted : November 8, 2013
Last Update Posted : July 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Rectal Prolapse||Procedure: endoluminal rectal prolapse repair under sedation||Not Applicable|
.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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Primary Completion Date :||March 22, 2018|
|Actual Study Completion Date :||March 22, 2018|
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
- rectal prolapse recurrence [ Time Frame: 12 months ]
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
|United States, New York|
|Weill Cornell Medical Center- NYPH|
|New York, New York, United States, 10065|
|Principal Investigator:||Jeffrey W Milsom, MD||Weill Medical College of Cornell University|