Spots Global Cancer Trial Database for Rectal Cancer Anastomosis 4 Check Study

Study Description

Brief Summary: Anastomotic failure (AF), including anastomotic leakage (AL), increases morbidity and mortality after colorectal cancer (CRC) resection. An inadequate perfusion of the anastomosis or technical stapling defects may contribute to AF. Several studies evaluated the singular use of intraoperative near infrared (NIR) indocyanine green (ICG)-induced fluorescence angiography (FA) and air leak testing to assess the integrity and the perfusion levels of the colorectal anastomosis. So far, a combined use of these methodologies, although acknowledged has not yet been tested as an indicator of postoperative AF or of intra-operative anastomotic repair in a prospective setting. This study aims to implement the intraoperative anastomotic assessment in a prospective series of patients undergoing rectal resection plus primary anastomosis for rectal cancer with or without ostomy, using a semi-quantitative check of 4 items (4-check). The procedure will include NIR-ICG-induced FA (to assess perfusion), air leak test and evaluation of the anastomotic donuts (to assess for the presence of technical defects). Included patients will be those scheduled for elective rectal resection with total or partial mesorectal excision and primary colo-rectal anastomosis with/or without protective ostomy. Primary outcomes will be the overall incidence of intra-operative anastomotic repair and the rate of post-operative AF. Secondary outcomes will be the overall incidence of adverse events and serious complications, the estimation of costs and resources, the operative time, hospitalization and post-operative measurement of inflammatory markers.

Detailed Description: All consecutive patients undergoing rectal resection (open and mini-invasive procedures) plus primary anastomosis for rectal cancer selected for the study will udergo a surgical intra-operative assessment of the anastomosis based on the check of the following 4 items (4-check): 1. Extra-luminal (serosa) evaluation of the proximal colon and distal rectal stump perfusion based on a semi-quantitative assessment of the near infrared (NIR) indocyanine green (ICG)-induced fluorescence angiography (FA). 2. Endo-luminal (mucosal) evaluation of the proximal colon and distal rectal stump perfusion based on a semi-quantitative assessment of the NIR-ICG-induced FA. 3. Air leak test (extra-luminal and reverse). 4. Assessment of the anastomotic donuts. aiming to test the efficacy of the procedure (overall incidence of intra-operative anastomosis repairs) and the overall incidence of anastomotic failure

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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