Effects of Anesthetic Techniques on Time to Start of Adjuvant Chemotherapy Following Surgery for Colorectal Cancer

NCT04493905 | Completed

• 1 other identifier: ENCORE
• Study Type: observational
• Target: 5,500
• Locations: 1 country
• Sites: 1

Brief Summary

Colorectal cancer (CRC) is the third most common cancer in the world with a high postoperative mortality (2 - 6%) as well as a low 5-year survival (40%). Despite advances in surgery and the use of minimally invasive laparoscopic surgery in recent years and adjuvant chemotherapy after surgery, long-term prognosis has only improved marginally. Epidural analgesia is commonly used as a part of the perioperative management of patients undergoing open, colorectal cancer surgery. Not only does it reduce pain and stress, epidurals have been shown to reduce perioperative inflammation and preserve immunological function, all of which may be beneficial in perioperative tumorigenesis. In several retrospective studies, anesthesia and choice of analgesia have shown to improve long-term survival, but no randomized studies have been published in the literature today. Similarly, the benefits of propofol anesthesia in comparison to inhalational anesthesia have recently been high-lighted in relation to cancer surgery, and many patients today request the use of epidurals, total intravenous anesthesia and loco-regional anesthetic technique during surgery, without clear evidence from prospective studies in the literature. Therefore, the question as to the real benefit of anesthesia technique in postoperative outcomes and tumor recurrence remain unanswered, and skepticism abounds amongst both surgeons and anesthesiologists. It is therefore important to study short- and long-term outcomes in patients undergoing CRC surgery, comparing epidural vs. no epidural or inhalational vs. total intravenous anesthesia. However, prospective, randomized studies are costly, require many patients, and the benefits of choice of anesthesia and analgesia on outcome remain uncertain from the current literature. There is a clear diffusion in practice across the world in the choice of anesthesia for patients undergoing CRC surgery, a lack of evidence in the literature and an absence of guidelines on best practice anesthesia care. We believe that by performing a large, prospective, observational, international, pragmatic study, with low costs, it will be possible to answer some of the important questions pertaining to the choice of anesthesia and analgesia. The clinical trials network at the European Society of Anesthesiology will play an important role in the success of this study.

Conditions

Colorectal Neoplasms; Anesthesia; Drug Therapy; Surgery

Outcome Measures

Primary Outcomes (2)

• Time in days from onset of surgery for colorectal cancer (Stage I-III) to first initiation of planned adjuvant chemotherapy

  time between surgery and start of adjuvant chemotherapy

  8 weeks

• 30-day postoperative morbidity assessed by Clavein-Dindo classification

  Evaluation of morbidity 30 days after surgery

  30 days

Secondary Outcomes (2)

• Postoperative mortality for 0-30 days

  30 days

• Cancer recurrence or cancer-related death at 90 days, 1, 3 years

  90 days - 1 - 3 years

Eligibility Criteria

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

Study Population

Patients undergoing surgery for colorectal cancer (stage I-III).

You may qualify if:

• Age \> 18 years
• ASA I-III
• Scheduled for colorectal cancer surgery for stage I-III
• Signed written informed consent

You may not qualify if:

• Uncontrolled renal or liver disease, restrictive
• (limiting mobility) heart failure or ischemic heart disease
• Emergency surgery for suspected bowel obstruction from colorectal cancer
• Speech, language or cognitive difficulties
• Stage IV colorectal cancer when only palliative surgery is planned

Sponsors & Collaborators

• European Society of Anaesthesiology: lead

Study Sites (1)

Karolinska University Hospital

Stockholm, Sweden

Location

Related Publications (1)

• Bell M, Buggy DJ, Brattstrom D, Buchli C, Debouche S, Granath F, Riedel B, Gupta A. The effects of anaesthesia and analgesia on short- and long-term outcomes following colorectal cancer surgery: Protocol for an international, pragmatic, cohort study (ENCORE *). Eur J Anaesthesiol Intensive Care. 2024 Apr 26;3(3):e0051. doi: 10.1097/EA9.0000000000000051. eCollection 2024 Jun.

  PMID: 39916820 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Max Bell, MD/PhD

  Karolinska Institutet

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: July 30, 2020
• Study Start: December 1, 2021
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: April 10, 2024

Record last verified: 2024-04

Locations

SE (1)