{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T20:58:39Z","timestamp":1792789119070,"version":"4.5.0"},"reference-count":20,"publisher":"MDPI AG","issue":"18","license":[{"start":{"date-parts":[[2026,9,14]],"date-time":"2026-09-14T00:00:00Z","timestamp":1789344000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Exero Medical Ltd."},{"DOI":"10.13039\/501100024250","name":"Israel Innovation Authority","doi-asserted-by":"crossref","award":["75615"],"award-info":[{"award-number":["75615"]}],"id":[{"id":"10.13039\/501100024250","id-type":"DOI","asserted-by":"crossref"},{"id":"https:\/\/ror.org\/013kba371","id-type":"ROR","asserted-by":"crossref"}]},{"award":["75615"],"award-info":[{"award-number":["75615"]}],"id":[{"id":"https:\/\/ror.org\/013kba371","id-type":"ROR","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Diagnostics"],"abstract":"<jats:p>Background: Morbidity associated with anastomotic leak (AL) can be reduced by timely detection. Local electrophysiological parameters are highly sensitive to pathophysiological processes (inflammation\/ischemia) underlying AL and may enable early post-op monitoring ahead of clinical signs. A new approach to early leak detection includes post-operative measurement of bioelectric activity of the GI tract. The method has been implemented in a medical device that uses electrodes embedded in a standard surgical drain to continuously monitor local bowel myoelectric activity following GI surgery. Methods: A multicenter pilot study evaluated the performance of the device to support detection of clinically recognizable anastomotic leaks on post-operative day 3. The device\u2019s technology collected data that an algorithm classified to predict AL. Data were collected for a duration of 3\u201310 days, while the surgical drain was in place (without affecting routine care). Pilot endpoints were safety and performance analyses: sensitivity and specificity. Results: Fifty patients from 6 medical centers (mean age: 63.6 \u00b1 13.3 years; 38% male) undergoing elective anterior resection (laparoscopic (N = 26), robotic (N = 16), open (N = 8)) for cancer (N = 44), diverticulitis (N = 4), and rectal prolapse (N = 2) were included. Average anastomotic height was 9 \u00b1 5 cm from the anal verge. Grade C ALs were observed in 6.0% (N = 3) of the patients, resulting in increased hospitalization time (6.4 \u00b1 2.4 days with no leak vs. 15.0 \u00b1 7.9 days with Grade C leak). In this N = 50 cohort, the device had 100% sensitivity and 100% specificity at POD3 in prediction of Grade C leaks. Given the small number of events (three Grade C leaks, seven leaks overall), these results are preliminary. No device-related serious adverse events were observed, and the standard drain form factor contributed to positive usability feedback. Conclusions: Pilot data suggest that the bioelectric sensing drain device is safe and warrants further evaluation as a potential adjunct for AL detection. The small study sample size and wide confidence intervals for key outcomes require confirmation in a pivotal diagnostic accuracy study with a fixed thresholding algorithm.<\/jats:p>","DOI":"10.3390\/diagnostics16182969","type":"journal-article","created":{"date-parts":[[2026,9,14]],"date-time":"2026-09-14T09:34:01Z","timestamp":1789378441000},"page":"2969","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Early Post-Operative Diagnosis of Anastomotic Leak by Local Electrophysiological Parameters: Multicenter Pilot Study"],"prefix":"10.3390","volume":"16","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2291-4850","authenticated-orcid":false,"given":"Elchanan","family":"Quint","sequence":"first","affiliation":[{"name":"Soroka University Medical Center, Beer-Sheva 84101, Israel"},{"name":"Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva 84105, Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7972-9424","authenticated-orcid":false,"given":"Lior","family":"Segev","sequence":"additional","affiliation":[{"name":"Sheba Medical Center (Tel HaShomer), Ramat Gan 52621, Israel"},{"name":"Gray School of Medicine, Tel Aviv University, Tel Aviv 69978, Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vladimir","family":"Gaziants","sequence":"additional","affiliation":[{"name":"Kaplan Medical Center, Rehovot 76100, Israel"},{"name":"Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem 91121, Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8633-0080","authenticated-orcid":false,"given":"Uri","family":"Netz","sequence":"additional","affiliation":[{"name":"Soroka University Medical Center, Beer-Sheva 84101, Israel"},{"name":"Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva 84105, Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Avi","family":"Reshef","sequence":"additional","affiliation":[{"name":"Soroka University Medical Center, Beer-Sheva 84101, Israel"},{"name":"Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva 84105, Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1746-0348","authenticated-orcid":false,"given":"Ian","family":"White","sequence":"additional","affiliation":[{"name":"Gray School of Medicine, Tel Aviv University, Tel Aviv 69978, Israel"},{"name":"Beilinson Hospital, Rabin Medical Center, Petah Tikva 49100, Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yulie","family":"Hagani","sequence":"additional","affiliation":[{"name":"Exero Medical, Jersey City, NJ 07305, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Udi","family":"Shenker","sequence":"additional","affiliation":[{"name":"Exero 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