Endoluminal and Needlescopic Assisted Repair of Rectal Prolapse



Status:Recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:75 - 100
Updated:8/3/2018
Start Date:May 20, 2013
End Date:December 2019

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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.

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
We found this trial at
1
site
New York, New York 10065
Principal Investigator: Jeffrey W Milsom, MD
?
mi
from
New York, NY
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