Rectal CancerREC4TNCT04637061
Rectal Cancer Anastomosis 4 Check Study
An observational study of Rectal Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- 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, Air Leak test and Evaluation of the anastomotic rings
- Type of treatment
- Injection or infusion
- How many people
- 287 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2021to 1 Jun 2023
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- • 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).
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- 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.
Trial locations and contacts
No sites are listed yet.
Laura Lorenzon, MD PhD contact
About this study
Official title: Rectal Cancer 4 Check Study
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.
Read the 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
- Conditions
- Rectal Cancer
- Being tested
- 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, Air Leak test, Evaluation of the anastomotic rings
- Keywords
- rectal cancer, indocyanine green, fluorescence angiography, surgery
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 anastomosisCombination product
Also called Near Infrared Fluorescence angiography, indocyanine green
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.
Air Leak testDiagnostic 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 ringsDiagnostic test
The assessment of the anastomotic rings following mechanical anastomosis will be recorded as complete/incomplete
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
intra-operative anastomosis repairs
defined as additional suturing or re-do anastomosis
Measured: 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
Measured: 01/01/2021 to 31/12/2022
Secondary outcomes (6)
Rate of of adverse events
any medical or surgical complications
Measured: 01/01/2021 to 31/12/2022
Rate of 30-day major complications
Clavien-Dindo grade IIIb-IV
Measured: 01/01/2021 to 31/12/2022
Measure of costs
Costs resource utilization for the procedure
Measured: 01/01/2021 to 31/12/2022
Medan length of post-operative stay
post-operative stay (measured in days)
Measured: 01/01/2021 to 31/12/2022
C-Reactive Protein (CRP) measurement
measurement conducted in postoperative days 1, 3 \& 5 (optional) using mg/L
Measured: 01/01/2021 to 31/12/2022
Procalcitonin (PCT) measurement
measurement conducted in postoperative days 1, 3 \& 5 (optional) using mg/L ng/mL
Measured: 01/01/2021 to 31/12/2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start1 Jan 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 287 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roberto Persiani, MD, Principal investigator, Fondazione Policlinico Universitarioa A Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04637061
- Sponsor's protocol ID
- 04101969
- Acronym
- REC4T
- Status last verified
- Nov 2020
- First submitted
- 14 Nov 2020
- Last updated
- 25 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rectal Cancer 4 Check Study
- ClinicalTrials.gov ID
- NCT04637061
- Acronym / sponsor ID
- REC4T / 04101969
- Conditions
- Rectal Cancer
- Keywords
- rectal cancer, indocyanine green, fluorescence angiography, surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 287 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 19 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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):
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| REC4T study patients | – | 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 ringsRectal 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (14 listed)
- • Patient pregnant or suspected pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 anastomosisAlso: Near Infrared Fluorescence angiography, indocyanine greenExtra-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. | Combination product | REC4T study patients |
| Air Leak testThis 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. | Diagnostic test | REC4T study patients |
| Evaluation of the anastomotic ringsThe assessment of the anastomotic rings following mechanical anastomosis will be recorded as complete/incomplete | Diagnostic test | REC4T study patients |
Primary outcome
intra-operative anastomosis repairs
Time frame: 01/01/2021 to 31/12/2022
defined as additional suturing or re-do anastomosis
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
6 secondary outcomes
Rate of of adverse events
Time frame: 01/01/2021 to 31/12/2022
Rate of 30-day major complications
Time frame: 01/01/2021 to 31/12/2022
Measure of costs
Time frame: 01/01/2021 to 31/12/2022
Medan length of post-operative stay
Time frame: 01/01/2021 to 31/12/2022
C-Reactive Protein (CRP) measurement
Time frame: 01/01/2021 to 31/12/2022
Procalcitonin (PCT) measurement
Time frame: 01/01/2021 to 31/12/2022
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Lorenzon, MD PhD contact
Roberto Persiani, MD principal investigator
Fondazione Policlinico Universitarioa A Gemelli IRCCS
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roberto Persiani, MD (0630154511 ext. 0630154511, roberto.persiani@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intra-operative anastomosis repairs (time frame: 01/01/2021 to 31/12/2022). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2020.