Rectal Prolapse Clinical Trial
Official title:
Endoluminal and Needlescopic Assisted Repair of Rectal Prolapse With Abdominal Fixation Under Sedation and Local Anesthesia
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.
.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.
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