Endoluminal and Needlescopic Assisted Repair of Rectal Prolapse

Rectal Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01980043
• Other study ID #: 1209013050
• Status: Completed
• Phase: N/A
• Start date: May 20, 2013
• Est. completion date: March 22, 2018

Study information

• Verified date: July 2019
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 22, 2018
• Est. primary completion date: March 22, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Prolapse
• Rectal Prolapse

Intervention

Procedure:
• endoluminal rectal prolapse repair under sedation
endoluminal rectal prolapse repair under sedation

Locations

Country	Name	City	State
United States	Weill Cornell Medical Center- NYPH	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Olympus

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rectal prolapse recurrence		12 months