Rectal Cancer Anastomosis 4 Check Study

Rectal Cancer Clinical Trial

— REC4T  

Official title:

Rectal Cancer 4 Check Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04637061
• Other study ID #: 04101969
• Status: Not yet recruiting
• Start date: January 1, 2021
• Est. completion date: June 1, 2023

Study information

• Verified date: November 2020
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Roberto Persiani, MD
• Phone: 0630154511
• Email: roberto.persiani[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 287
• Est. completion date: June 1, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years or older.

• Rectal adenocarcinoma or benign polyp with indication for rectal resection with total or partial mesorectal excision and primary colo-rectal anastomosis with/or without protective ostomy.

• Patients undergoing upfront surgery and patients undergoing neoadjuvant therapy followed by surgery.

• Patients with adequate performance status (Eastern Cooperative Oncology Group Scale score of =2).

• Patient must sign the Informed Consent Form (ICF) before any study procedures and agrees to attend all study visits.

• Selection of the patient before inclusion.

Exclusion Criteria:

• • Patient pregnant or suspected pregnancy.

• Patient with a comorbid illness or condition that would preclude the use of surgery.

• Past medical history of Inflammatory Bowel Disease (IBD).

• Synchronous cancers requiring extended sub-total or total colectomies.

• Long lasting therapy with steroids to be continued in the peri-operative period (4 weeks previous and 4 weeks after surgery).

• Use of antiplatelet drug (anti-aggregant) and/or oral anti-coagulant drug to be continued in the peri-operative period (1 week previous and 4 weeks after surgery).

• Patients assessed as American Society of Anesthesiologists (ASA) physical status 4.

• Patients with clinical stage of cT4b tumor after neoadjuvant theapy.

• Metastatic disease (clinical Stage 4).

• Patient undergoing emergency procedures.

• Planned colonic surgery along with major concomitant procedures (i.e. liver resections, other intestinal resections).

• Previous colon surgery (excluding appendectomy).

• Non-restorative procedures (i.e. Miles or Hartman resection).

• Colo-anal manual anastomosis.

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

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
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.

Diagnostic Test:
• Air Leak test
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.
• Evaluation of the anastomotic rings
The assessment of the anastomotic rings following mechanical anastomosis will be recorded as complete/incomplete

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intra-operative anastomosis repairs	defined as additional suturing or re-do anastomosis	01/01/2021 to 31/12/2022
Primary	Rate of 30 day-anastomotic failure (AF)	defined as anastomotic-related morbidity, including anastomotic leakage, pelvic abscess, anastomotic-related fistula, sinus, and anastomotic stricture	01/01/2021 to 31/12/2022
Secondary	Rate of of adverse events	any medical or surgical complications	01/01/2021 to 31/12/2022
Secondary	Rate of 30-day major complications	Clavien-Dindo grade IIIb-IV	01/01/2021 to 31/12/2022
Secondary	Measure of costs	Costs resource utilization for the procedure	01/01/2021 to 31/12/2022
Secondary	Medan length of post-operative stay	post-operative stay (measured in days)	01/01/2021 to 31/12/2022
Secondary	C-Reactive Protein (CRP) measurement	measurement conducted in postoperative days 1, 3 & 5 (optional) using mg/L	01/01/2021 to 31/12/2022
Secondary	Procalcitonin (PCT) measurement	measurement conducted in postoperative days 1, 3 & 5 (optional) using mg/L ng/mL	01/01/2021 to 31/12/2022