Endoluminal and Needlescopic Assisted Repair of Rectal Prolapse

Weill Cornell Medicine (WCM)

Status: Completed

Conditions: Rectal Prolapse

Treatments: Procedure: endoluminal rectal prolapse repair under sedation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01980043

1209013050

Details and patient eligibility

About

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.

Full description

.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.

Enrollment: 10 patients

Sex: All

Ages: 75 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Rectal Prolapse

Other group

Description:

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.

Treatment:

Procedure: endoluminal rectal prolapse repair under sedation