eP806 - Colorectal Balloon Tube as an Alternative to Temporary Ileostomy Following Proctectomy - A Multicenter, Randomized, Open-label, Non-Inferiority Trial

Monday, June 3, 2024

10:48 AM – 10:53 AM ET, USA

Location: Room 318-320

Senior Author(s)

MF

Mark Falvo, MD

Assistant Professor Department of Surgery, Jacobs School of Medicine & Biomedical Sciences
State University of New York at Buffalo
EAST AMHERST, New York, United States

Disclosure information not submitted.

ePoster Presenter(s)

Jaafar Elnagar, MBBS

Fellow
University At Buffalo
University of Buffalo
BUFFALO, NY, United States

All relevant financial disclosures have been managed and will be listed below.
This individual has no financial relationships with ineligible companies.

Author(s)

JV

Jeffery J. Visco, n/a

Assistant Program Director SUNY at Buffalo
UBMD
Clarence Center, New York, United States

Disclosure information not submitted.
tA

timothy M. Adams, MD

Colorectal surgeon
University of Buffalo Surgery
Buffalo, New York, United States

Disclosure information not submitted.
SB

Steven Barone, ASCRS Member

Clinical Assistant Professor
University at Buffalo
Williamsville, New York, United States

Disclosure information not submitted.
JM

Joseph D. Mills, MD

Associate Program Director
University at Buffalo
West Seneca, New York, United States

Disclosure information not submitted.
JO

John Ortolani, MD

Clinical Assistant Professor
University at Buffalo Jacobs School of Medicine
Buffalo, New York, United States

Disclosure information not submitted.
Jessica Martinolich, MD

Assistant Clinical Professor
University at Buffalo
Buffalo, New York, United States

All relevant financial disclosures have been managed and will be listed below.
This individual has no financial relationships with ineligible companies.
JK

Jae Hwang Kim, n/a

Honorary professor of Sugery, Yeungnam University
Yeungnam University
Suseong-gu, Taegu-jikhalsi, Republic of Korea

Disclosure information not submitted.

Image or Table (Do Not add text here):

Purpose/Background: Temporary stomas are commonly created to protect anastomotic wounds occurring after rectal resection. However, complications related to stomas are reported at 25-50%, and in 12-40% of cases, stoma reversal is hindered by various issues. Despite the development of various alternatives to temporary stoma surgery, none have successfully entered the market. The newly developed COLO-BT™, designed to replace temporary stomas, is a fecal diverting device that can be worn for three weeks and removed without anesthesia or surgery. The objective of this trial is to evaluate the safety and effectiveness of COLO-BT™.Methods/Interventions: This study includes 256 patients aged 19-80, with an expected anastomosis location above 4cm and at or below 15cm from the anus. Up to 7 study sites in the U.S. may enroll a maximum of 75 subjects each. Subjects are randomly assigned to the control (stoma) or test (COLO-BT™) group in a 1:1 ratio, based on surgical conditions. The study obtained FDA-IDE approval, and patient enrollment began in December 2023. The primary endpoint is evaluated as the "Study Success Case," defined when both "Clinical Success" and "Technical Success" criteria are met throughout the 180-day (±7 days) monitoring period following the initial surgical treatment with COLO-BT™ or temporary stoma. "Clinical Success" is achieved if no DINDO Grade II or higher-grade events occur, COLO-BT™ or stoma successfully maintains bypass function, and no clinical complications or adverse events requiring intervention are observed. "Technical Success" is determined by the absence of gross leaks around the device in the contrast study conducted on POD 21 days (±2 days) for the test group, and the absence of complications requiring intervention for the control group. Secondary endpoints include evaluating stoma construction rate at the 180-day (±7 days) timepoint, device early migration rate, occurrence of anastomotic leakage, tissue deformities at FDD Tube fixing site, COLO-BT™ procedure time and difficulty, Low Anterior Resection Syndrome (LARS) Score Questionnaire, colonic irrigation usability, and adverse events and re-admission rates related to COLO-BT™ or stoma.Results/Outcomes: Study Hypothesis: The clinical results of the test group using COLO-BT™ are not inferior to the control group with temporary ileostomy, concerning the overall rate of the total number of "Study Success Cases" achieved during the 180-day (±7 days) monitoring period.Conclusion/

Discussion: Patients undergoing rectal resection with mid to low rectal anastomosis frequently undergo diverting loop ileostomy due to higher anastomotic leak risk. Diverting ileostomy can minimize clinical manifestations of anastomotic leak, but are commonly associated with complications that range from dehydration and acute kidney injury, to prolapse and parastomal hernia. COLO-BT is a fecal diversion device that is placed intra-operatively at the time of anastomosis creation, which would offer the same advantages as an ileostomy without the added morbidity. We are currently enrolling patients for the trial.