Endoluminal and Needlescopic Assisted Repair of Rectal Prolapse

Study Overview
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Brief Summary
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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.

Detailed Description
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.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 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.

Official Title
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Endoluminal and Needlescopic Assisted Repair of Rectal Prolapse With Abdominal Fixation Under Sedation and Local Anesthesia

Conditions
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Rectal Prolapse

Intervention / Treatment
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* Procedure: endoluminal rectal prolapse repair under sedation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 75 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Rectal Prolapse<br>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<br>* endoluminal rectal prolapse repair under sedation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rectal prolapse recurrence |  | 12 months |