Rectal Cancer Anastomosis 4 Check Study

NCT04637061 | Unknown DMC FDA Drug

• 1 other identifier: 04101969
• Study Type: observational
• Target: 287
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rectal Cancer

Keywords

rectal cancer; indocyanine green; fluorescence angiography; surgery

Outcome Measures

Primary Outcomes (2)

• intra-operative anastomosis repairs

  defined as additional suturing or re-do anastomosis

  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

  01/01/2021 to 31/12/2022

Secondary Outcomes (6)

• Rate of of adverse events

  01/01/2021 to 31/12/2022

• Rate of 30-day major complications

  01/01/2021 to 31/12/2022

• Measure of costs

  01/01/2021 to 31/12/2022

• Medan length of post-operative stay

  01/01/2021 to 31/12/2022

• C-Reactive Protein (CRP) measurement

  01/01/2021 to 31/12/2022

Study Arms (1)

REC4T study patients

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

Interventions

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 COMBINATION_PRODUCT

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

REC4T study patients

Air Leak test DIAGNOSTIC_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.

REC4T study patients

Evaluation of the anastomotic rings DIAGNOSTIC_TEST

The assessment of the anastomotic rings following mechanical anastomosis will be recorded as complete/incomplete

REC4T study patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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: 1. Open surgery. 2. Laparoscopic surgery (operations performed through small incisions and ports placements independently from the type and length of incision for specimen extraction). 3. Robot-assisted surgery (using robotic systems to aid in surgical procedures independently from the type and length of incision for specimen extraction). 4. TaTME. Mini-invasive bottom up approach for mesorectal dissection and colorectal anastomosis using a single/double team, independently from the type and length of incision for specimen extraction. The following procedures is required during surgery: Routine splenic flexure mobilization.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Roberto Persiani, MD

  Fondazione Policlinico Universitarioa A Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roberto Persiani, MD

CONTACT

0630154511; roberto.persiani@policlinicogemelli.it

Laura Lorenzon, MD PhD

CONTACT

laura.lorenzon@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2020
• First Posted: November 19, 2020
• Study Start: January 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: June 1, 2023
• Last Updated: November 25, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share