An observational study in Rectal Cancer, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-25.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational
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.
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):
1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
This study's planned enrollment of 287 is above the median of 160 across 413 observational studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 920 studies on the registry; 529 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Selected patients will receive oral bowel preparation as for colonoscopy, 2 days before surgery and managed with ERAS protocol. Patients should be treated with rectal resection with TME or PME and mechanical anastomosis with a circular stapler, using one of the following approaches:
The following procedures is required during surgery:
Routine splenic flexure mobilization.
Exclusion Criteria:
Patient pregnant or suspected pregnancy.
Rectal adenocarcinoma or polyp with indication for resection and primary colo-rectal mechanical anastomosis using a circular stapler with/or without protective ostomy undergoing upfront surgery and patients undergoing neoadjuvant therapy followed by surgery (see Inclusion/Exclusion Criteria)
Combination Product: 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 · Diagnostic Test: Air Leak test · Diagnostic Test: Evaluation of the anastomotic rings
Extra-luminal (serosa) and Endo-luminal (mucosal) evaluation of the proximal colon and distal rectal stump perfusion based on a semi-quantitative NIR-ICG-induced FA. This will be conducted administering IV a bolus of 3.75 to 7.5 mg of ICG and evaluated using a Fluorescence Imaging System; following after completion of the anastomosis a second bolos of 3.75 to 7.5 mg of ICG will be administered IV and the anastomosis will be visualized by insertion of the system trans-anally. Colon and rectal segments and quadrants will be scored for any defect of perfusion.
Also known as: Near Infrared Fluorescence angiography, indocyanine green
This will be conducted insufflaying air in the anastomosis through a proctoscope, tube or a flexible endoscope, after filling of the pelvis with saline solution and luminal occlusion of the intestine proximal to the anastomosis. Also, the anastomosis will be checked transanally for the presence of air leak.
The assessment of the anastomotic rings following mechanical anastomosis will be recorded as complete/incomplete
intra-operative anastomosis repairs
defined as additional suturing or re-do anastomosis
Time frame: 01/01/2021 to 31/12/2022
Rate of 30 day-anastomotic failure (AF)
defined as anastomotic-related morbidity, including anastomotic leakage, pelvic abscess, anastomotic-related fistula, sinus, and anastomotic stricture
Time frame: 01/01/2021 to 31/12/2022
Rate of of adverse events
any medical or surgical complications
Time frame: 01/01/2021 to 31/12/2022
Rate of 30-day major complications
Clavien-Dindo grade IIIb-IV
Time frame: 01/01/2021 to 31/12/2022
Measure of costs
Costs resource utilization for the procedure
Time frame: 01/01/2021 to 31/12/2022
Medan length of post-operative stay
post-operative stay (measured in days)
Time frame: 01/01/2021 to 31/12/2022
C-Reactive Protein (CRP) measurement
measurement conducted in postoperative days 1, 3 \& 5 (optional) using mg/L
Time frame: 01/01/2021 to 31/12/2022
Procalcitonin (PCT) measurement
measurement conducted in postoperative days 1, 3 \& 5 (optional) using mg/L ng/mL
Time frame: 01/01/2021 to 31/12/2022
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS