Author:
Bell Max,Buggy Donal J.,Brattström Daniel,Buchli Christian,Debouche Sophie,Granath Fredrik,Riedel Bernard,Gupta Anil
Abstract
BACKGROUND
Colorectal cancer (CRC) is the second most frequent cause of global cancer mortality. Most patients with CRC require surgical tumour resection, with certain stages of CRC (Stage II/III) also requiring postoperative chemotherapy. The timing of postoperative chemotherapy is largely determined by postoperative recovery. Delayed return to intended oncologic therapy (RIOT) by >8 weeks results in worse oncologic outcomes. RIOT is thus an important surrogate marker of outcome for patients with stage II/III CRC. We will test the hypothesis that anaesthetic technique during CRC resection surgery may affect RIOT.
OBJECTIVE
To test the association between anaesthetic and analgesic technique during CRC surgery and RIOT. To document Short-term Secondary outcomes including individual postoperative complications and a composite of all postoperative complications, the Comprehensive Complications Index (CCI) and to measure the time to recurrence (TTR) of cancer at 3 years.
DESIGN
This is a prospective, international, multicentre, observational cohort study.
SETTING
Global healthcare setting, with >140 centres in >30 nations.
PATIENTS
Inclusion criteria: All patients age >18 years, ASA I–III, with CRC stage I–III scheduled for elective CRC surgery (open or minimally invasive).
Exclusion criteria: Uncontrolled renal or liver disease, restrictive (limiting mobility) heart failure or ischemic heart disease (ASA IV–V). Speech, language, or cognitive difficulties precluding signing informed consent to participate and Stage IV CRC.
PRIMARY OUTCOME MEASURES
Short -term: The duration from day of surgery to RIOT among patients expected to receive postoperative chemotherapy. Long-term: incidence of recurrence and time to recurrence (TTR) at 3 years after primary curative surgery
SECONDARY OUTCOMES
Postoperative complications within 30 days of surgery, length of hospital stay, Days at Home at 30 and 90 days (DAH-30, DAH-90) after surgery, and adverse events related to oncological treatment. We will also assess the burden of preoperative modifiable comorbid disease in patients. Exploratory endpoints will assess practice variation (including incidence of RIOT by demographic e.g. gender of patient, type of institution, country).
RESULTS
N/A.
CONCLUSIONS
N/A.
TRIAL REGISTRATION
The Effects of aNesthesia in COloREctal cancer outcome study: ENCORE, ClinicalTrials.gov Identifier: NCT04493905.
Publisher
Ovid Technologies (Wolters Kluwer Health)