Clinical trial NCT01980043: Endoluminal and Needlescopic Assisted Repair of Rectal Prolapse
Official title: Endoluminal and Needlescopic Assisted Repair of Rectal Prolapse With Abdominal Fixation Under Sedation and Local Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectal Prolapse
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Olympus
First posted: 2013-11-08
Enrollment: 10
Sex: ALL
Minimum age (years): 75
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: rectal prolapse recurrence
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medical Center- NYPH
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Jeffrey W Milsom, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Milsom JW, Trencheva K, Gadalla F, Abramovitz S, Garrett KA. Rectal Prolapse Repair with Abdominal Fixation Under Sedation and Local or Epidural Anesthesia: Prospective Pilot Study in 10 Elderly Subjects. J Laparoendosc Adv Surg Tech A. 2021 Aug;31(8):911-916. doi: 10.1089/lap.2019.0804. Epub 2020 Oct 21.