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NCT04493905Completed

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

The Effects of Anesthetic Techniques on Time to Start of Adjuvant Chemotherapy, and Early- and Late-outcomes Following Surgery for Colorectal Cancer A Prospective, Multicenter, International, Observational, Pragmatic Study

Source: ClinicalTrials.gov · Last updated 10 Apr 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
5500 (actual)
First submitted
28 Jul 2020
Start date
1 Dec 2021
Primary completion date
31 Mar 2024
Lead sponsor
European Society of Anaesthesiology
NCT number
NCT04493905

What you commit to

  • Study type: Observational
  • Participants enrolled: 5500
  • From 1 Dec 2021 to the primary completion date, 31 Mar 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

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

Other

  • Speech, language or cognitive difficulties

Who the study is looking for

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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Karolinska University Hospital
Coordinator of this site? Confirm its status
StockholmSwedenUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.