Colorectal NeoplasmsENCORENCT04493905
Effects of Anesthetic Techniques on Time to Start of Adjuvant Chemotherapy Following Surgery for Colorectal Cancer
An observational study of Colorectal Neoplasms and Anesthesia, run by European Society of Anaesthesiology at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms, Anesthesia, Drug Therapy
- How many people
- 5,500 participants
- Where
- 1 siteSweden
- Study dates
- 1 Dec 2021to 31 Mar 2024
- 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: Patients undergoing surgery for colorectal cancer (stage I-III).
Who may be able to join
- Age > 18 years
- ASA I-III
- Scheduled for colorectal cancer surgery for stage I-III
- Signed written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
Primary objective To investigate the effect of anaesthetic technique on:
Short term: time to start of adjuvant chemotherapy in patients planned for RIOT Long term: Time to recurrence (TTR) at 3 years. (please see section 4.2 for details) Secondary objectives 0-30-day postoperative morbidity Length of hospital stay and days at home for 30 days (DAH-30) Adverse events related to oncological treatment (chemotherapy, radiotherapy) Study Subjects Patients with stage I-III colorectal cancer (stratified to stage and type of cancer) scheduled for upfront curative surgery.
Study design Prospective, multicentre, international, observational, pragmatic study Planned sample size 10000 patients from > 200 centres (minimum 40 patients/centre) Inclusion criteria Age > 18 years ASA I-III Scheduled for elective (planned) colorectal cancer surgery for stage I-III (open or minimally invasive) Signed written informed consent when requested by the local Ethics committee 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 Stage IV colorectal cancer Primary Outcomes Time to return to intended adjuvant (postoperative) chemotherapy (number of days after surgery) Time to recurrence (TTR) of cancer at 3 years (please see section 4.2 for details) Secondary outcome Percentage of complications within 30 days of surgery as graded by the Clavien-Dindo classification Other adverse events not included in the C-D classification within 30 days Length of hospital stay defined as days from index surgery to arrival at original living facility Days at home for 0-30 days (DAH-30) after index surgery Adverse events related to oncological treatment
- Conditions
- Colorectal Neoplasms, Anesthesia, Drug Therapy, Surgery
- Medical subject headings
- Colorectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 weeks
30-day postoperative morbidity assessed by Clavein-Dindo classification
Evaluation of morbidity 30 days after surgery
Measured: 30 days
Secondary outcomes (2)
Postoperative mortality for 0-30 days
Evaluation of mortality 30 days after surgery
Measured: 30 days
Cancer recurrence or cancer-related death at 90 days, 1, 3 years
evaluation of cncer recurrence or dath at 90 days-1 and 3 years
Measured: 90 days - 1 - 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start1 Dec 2021
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- 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
- 5,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Society of Anaesthesiology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Max Bell, MD/PhD, Study chair, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04493905
- Sponsor's protocol ID
- ENCORE
- Acronym
- ENCORE
- Status last verified
- Apr 2024
- First submitted
- 28 Jul 2020
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 39916820
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04493905
- Acronym / sponsor ID
- ENCORE / ENCORE
- Conditions
- Colorectal Neoplasms, Anesthesia, Drug Therapy, Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,500 participants (actual)
- Lead sponsor
- European Society of AnaesthesiologyUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 30 Jul 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.
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.
Detailed description
Primary objective To investigate the effect of anaesthetic technique on:
Short term: time to start of adjuvant chemotherapy in patients planned for RIOT Long term: Time to recurrence (TTR) at 3 years. (please see section 4.2 for details) Secondary objectives 0-30-day postoperative morbidity Length of hospital stay and days at home for 30 days (DAH-30) Adverse events related to oncological treatment (chemotherapy, radiotherapy) Study Subjects Patients with stage I-III colorectal cancer (stratified to stage and type of cancer) scheduled for upfront curative surgery.
Study design Prospective, multicentre, international, observational, pragmatic study Planned sample size 10000 patients from > 200 centres (minimum 40 patients/centre) Inclusion criteria Age > 18 years ASA I-III Scheduled for elective (planned) colorectal cancer surgery for stage I-III (open or minimally invasive) Signed written informed consent when requested by the local Ethics committee 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 Stage IV colorectal cancer Primary Outcomes Time to return to intended adjuvant (postoperative) chemotherapy (number of days after surgery) Time to recurrence (TTR) of cancer at 3 years (please see section 4.2 for details) Secondary outcome Percentage of complications within 30 days of surgery as graded by the Clavien-Dindo classification Other adverse events not included in the C-D classification within 30 days Length of hospital stay defined as days from index surgery to arrival at original living facility Days at home for 0-30 days (DAH-30) after index surgery Adverse events related to oncological treatment
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing surgery for colorectal cancer (stage I-III).
Key inclusion criteria (4 listed)
- Age > 18 years
- ASA I-III
- Scheduled for colorectal cancer surgery for stage I-III
- Signed written informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time in days from onset of surgery for colorectal cancer (Stage I-III) to first initiation of planned adjuvant chemotherapy
Time frame: 8 weeks
time between surgery and start of adjuvant chemotherapy
30-day postoperative morbidity assessed by Clavein-Dindo classification
Time frame: 30 days
Evaluation of morbidity 30 days after surgery
2 secondary outcomes
Postoperative mortality for 0-30 days
Time frame: 30 days
Cancer recurrence or cancer-related death at 90 days, 1, 3 years
Time frame: 90 days - 1 - 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Derived from this study: PubMed 39916820Bell 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.
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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.
Max Bell, MD/PhD study chair
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Neoplasms and Anesthesia, run by European Society of Anaesthesiology at 1 site in Sweden.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in days from onset of surgery for colorectal cancer (Stage I-III) to first initiation of planned adjuvant chemotherapy (time frame: 8 weeks). 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?
On the ClinicalTrials.gov record for NCT04493905, which also lists 1 linked publication.
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 10 Apr 2024.