LB102 - Functional Biosensing for Early Detection of Anastomotic Complications: Results of a Phase II Clinical Trial

Monday, May 11, 2026

10:38 AM - 10:45 AM ET

Presenting Author(s)

Mehraneh D. Jafari, MD (she/her/hers)

Director of Clinical Research; Department of Surgery
Weill Cornell Medicine
Weill Cornell Medicine
New York, NY, United States

All disclosed relationships have been reviewed and managed prior to the start of this activity. Any relevant relationships will be listed below. This individual has no financial relationships to disclose

Author(s)

MJ

Michael A. Jobst, American Board of Colon and Rectal Surgery

Surgeon
Surgical Associates PC
Lincoln, Nebraska, United States

Disclosure information not submitted.
IP

Ilia Pinsk, MD

Head of the Unit of Colorectal Surgery,
Soroka Medical Center, Beer Sheva, Israel
Beer Sheba, HaDarom, Israel

Disclosure information not submitted.
DN

Deborah Nagle, MD

Chief, Division of Colon and Rectal Surgery
Stony Brook University Hospital
Stony Brook, New York, United States

Disclosure information not submitted.
RM

Rafael Miller, MD, general surgery

Senior Suegeon,
Kaplan Medical Center
Rehovot, HaMerkaz, Israel

Disclosure information not submitted.
DM

Dr. Joseph Martz, 207576

Vice Chair Colorectal Surgery
Northwell Health
New York, New York, United States

Disclosure information not submitted.
SK

Sandy Kavalukas, MD

Assistant Professor
University of Louisville
Louisville, Kentucky, United States

All disclosed relationships have been reviewed and managed prior to the start of this activity. Any relevant relationships will be listed below. This individual has no financial relationships to disclose
Mark Soliman, MD, MBA, FACS, FASCRS

System Chief and Program Medical Director of Colorectal Surgery
AdventHealth
Altamonte Springs, FL, United States

All disclosed relationships have been reviewed and managed prior to the start of this activity. Any relevant relationships will be listed below. This individual has no relevant financial relationships.
NW

Nir Wasserberg, MD, general and colorectal surgery

Head of General Surgery Array, Rabin Medical Center
Rabin Medical Center
Petach Tikva, HaMerkaz, Israel

Disclosure information not submitted.
AA

Ahmed Allawi, MD, FACS (he/him/his)

Chief, Colorectal Surgery Division
AdventHealth Tampa
University of Central Florida
Tampa, FL, United States

All disclosed relationships have been reviewed and managed prior to the start of this activity. Any relevant relationships will be listed below. This individual has no financial relationships to disclose
Eric M. Haas, MD,FACS, FASCRS

Chief of Colorectal Surgery
Houston Colon Foundation
Houston, Texas, United States

Disclosure information not submitted.
Patricia Sylla, MD, FACS, FASCRS (she/her/hers)

System Chief of Colon and Rectal Surgery
Mount Sinai Hospital
Icahn School of Medicine at Mount Sinai
New York, New York, United States

All disclosed relationships have been reviewed and managed prior to the start of this activity. Any relevant relationships will be listed below. This individual has no relevant financial relationships.

Senior Author(s)

MB

Matan BenDavid, MD FRACS

Staff Specialist General Surgery. Trauma Director. HPB Surgeon
Townsville University Hospital
Townsville, Queensland, Australia

Disclosure information not submitted.

Purpose/Background: Anastomotic leak (AL) after colorectal surgery remains a major source of morbidity and mortality, and current detection methods often fail to identify leaks early enough for timely and effective rescue. We propose a drain based sensing device that continuously monitors tissue recovery parameters at the anastomotic site. We hypothesize that monitoring of tissue impedance and intrinsic bowel myoelectric signals will provide high sensitivity and specificity for early leak detection (POD2-3) compared with existing clinical modalities.

Methods/Interventions: We conducted a multicenter clinical trial investigating the sensitivity and specificity of anastomotic leak detection device which monitored local electrophysiological signals from the bowel wall. A standard surgical drain with integrated microelectrodes was placed adjacent to the anastomosis until POD3. Electrophysiological parameters served as a proxy for the physiological processes underlying tissue healing and the development of surgical complications, reflecting ischemia, motility disruption, and local inflammation. The sensor wirelessly transmitted data to a cloud platform for automated analysis. Patient with colorectal anastomosis with no diversion were recruited. Both surgeons and patients were blinded to the results of the detection divice. Care did not deviate from standard of care (SOC).

Results/Outcomes: We enrolled 222 patients across 12 international sites, of which 47.5% were male with an average age of 63.2+12.8 years. The average height of the anastomosis was 13.8+5.8cm from the anal verge. Technical success was 93.7% (95% CI 89.6%-96.5%). We had no device related adverse events. AL occurred in 6.3% (N=14) of which Grade C was 5.4% (N=12) and 2 patients were diagnosed with a grade B leaks. Diversion was performed in 66.7% (N=8) of Grace C leaks. Of the patients with a leak 29% were clinically diagnosed with AL on readmission. The mean overall length of stay (including re-admissions where applicable) was 16.4+11.5 for grade Cs and 7.5+0.7 for grade Bs. By POD3, the device demonstrated overall AL detection sensitivity of 100.0% (95% CI 71.5%-100%) with specificity of 88.3% (95% CI 83.0%-92.5) for Grade C leaks and sensitivity of 84.6% (95% CI 54.6%-98.1%) with specificity of 88.7% (95% CI 83.4%-92.8) for Grade B+C. Diagnostic accuracy was 87.5% (95% CI: 82.2-91.7%). The AUC of 0.97 (95% CI: 0.96-0.99). The mean lead time to diagnosis of AL was 3.9 ± 3.7 days (p < 0.002) compared to clinical team. Re-operative rate for AL was 75% (9 from 12), with time to intervention of 7+3.8 days.

Conclusion/Discussion: The device showed excellent diagnostic performance, with AUC 0.97 and early detection of anastomotic leaks-identifying AL an average of 3.9 days sooner than the clinical team. By POD3, sensitivity and specificity were high for clinically significant leaks. These findings support the device as a reliable early‑detection tool with potential to improve timely intervention and postoperative outcomes.

Detection time: xBar vs. SOC

Time to detection of severe anastomotic leaks