- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04637061
Rectal Cancer Anastomosis 4 Check Study (REC4T)
Rectal Cancer 4 Check Study
Study Overview
Status
Conditions
Intervention / Treatment
- 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
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):
- 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).
- 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.
- Air leak test (extra-luminal and reverse).
- 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
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Roberto Persiani, MD
- Phone Number: 0630154511 0630154511
- Email: roberto.persiani@policlinicogemelli.it
Study Contact Backup
- Name: Laura Lorenzon, MD PhD
- Email: laura.lorenzon@policlinicogemelli.it
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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:
- Open surgery.
- Laparoscopic surgery (operations performed through small incisions and ports placements independently from the type and length of incision for specimen extraction).
- Robot-assisted surgery (using robotic systems to aid in surgical procedures independently from the type and length of incision for specimen extraction).
- 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.
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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)
|
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.
Other Names:
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
intra-operative anastomosis repairs
Time Frame: 01/01/2021 to 31/12/2022
|
defined as additional suturing or re-do anastomosis
|
01/01/2021 to 31/12/2022
|
Rate of 30 day-anastomotic failure (AF)
Time Frame: 01/01/2021 to 31/12/2022
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of of adverse events
Time Frame: 01/01/2021 to 31/12/2022
|
any medical or surgical complications
|
01/01/2021 to 31/12/2022
|
Rate of 30-day major complications
Time Frame: 01/01/2021 to 31/12/2022
|
Clavien-Dindo grade IIIb-IV
|
01/01/2021 to 31/12/2022
|
Measure of costs
Time Frame: 01/01/2021 to 31/12/2022
|
Costs resource utilization for the procedure
|
01/01/2021 to 31/12/2022
|
Medan length of post-operative stay
Time Frame: 01/01/2021 to 31/12/2022
|
post-operative stay (measured in days)
|
01/01/2021 to 31/12/2022
|
C-Reactive Protein (CRP) measurement
Time Frame: 01/01/2021 to 31/12/2022
|
measurement conducted in postoperative days 1, 3 & 5 (optional) using mg/L
|
01/01/2021 to 31/12/2022
|
Procalcitonin (PCT) measurement
Time Frame: 01/01/2021 to 31/12/2022
|
measurement conducted in postoperative days 1, 3 & 5 (optional) using mg/L ng/mL
|
01/01/2021 to 31/12/2022
|
Collaborators and Investigators
Investigators
- Principal Investigator: Roberto Persiani, MD, Fondazione Policlinico Universitarioa A Gemelli IRCCS
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 04101969
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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