Colorectal NeoplasmsNCT05412355
Effects of Incomplete ERAS on Clinical Outcomes in Patients With Colorectal Cancer
An observational study of Colorectal Neoplasms and Enhanced Recovery After Surgery, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 2 sites in China.
Trial summary
Enhanced recovery after surgery (ERAS) has been reported to be associated with improved outcomes in many studies, most of which involve short-term effects. Only a few studies have reported the long-term effects of highly compliant ERAS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms, Enhanced Recovery After Surgery
- What is being tested?
- ERAS protocol
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jun 2022to 10 Oct 2022
- 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: In this study, we are going to collect clinical data of patients undergoing laparoscopic radical surgery from four large hospitals between August 2008 and December 2016.
Who may be able to join
- 1. age older than 18 years;2. pathological diagnosis of colorectal cancer;3. radical surgery was performed; and 4. laparoscopic surgery was performed.
Who cannot join
- 1. ERAS compliance ≥70%; 2. open surgery; 3. switch to laparotomy after laparoscopic surgery; 4. pregnancy or lactation; 5. severe mental illness; 6. Simultaneous malignant tumors of multiple organs; 7. History of other malignant tumors; and 8. Emergency radical colorectal resection due to obstruction, perforation or bleeding.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 1 recruiting
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
Wuhan, Hubei, 430000
Xiaogang Shu, +8613959538950, sxg678@yahoo.com
- Active, not recruiting
Union Hospital，Tongji Medical College, Huazhong University of Science and Technology.
Wuhan, Hubei, 430000
About this study
Official title: Effects of Incomplete Enhanced Recovery After Surgery Program on Long-term Survival of Patients Undergoing Colorectal Cancer Surgery
Enhanced recovery after surgery (ERAS) has been reported to be associated with improved outcomes in many studies, most of which involve short-term effects. Only a few studies have reported the long-term effects of highly compliant ERAS. However, to the best of our knowledge, there are no large-scale comparisons between incomplete ERAS (compliance < 70%) and non-ERAS. The aim of this comparative study is to analyze and evaluate the long-term outcomes of incomplete ERAS in laparoscopic colorectal cancer surgery.
- Being tested
- ERAS protocol
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERAS protocolProcedure or surgery
ERAS protocol is a series of procedures that enhance the recovery of surgical patients. Patients were grouped according to whether the procedure was attempted.
| Study group | Role | What they receive |
|---|---|---|
| Incomplete ERAS | Incomplete ERAS was defined as ERAS compliance < 70%. Receives: Procedure: ERAS protocol | |
| Non-ERAS | non-ERAS was defined as not executing any ERAS programs. Receives: Procedure: ERAS protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
long-term survival
5-year Disease free survival and overall survival
Measured: Each patient will be followed for 5 years or until death
Secondary outcomes (1)
Postoperative complications
Postoperative complications within 30 days after surgery.
Measured: within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start1 Jun 2022
- Primary completion10 Aug 2022 (estimated)
- Study completion10 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaogang Shu, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Investigators
- Xiaogang Shu, MD.，PHD., Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05412355
- Sponsor's protocol ID
- UHCT22040
- Status last verified
- Jun 2022
- First submitted
- 6 Jun 2022
- Last updated
- 24 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the funders finished the study,the data will be available，if approved by PI.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Incomplete Enhanced Recovery After Surgery Program on Long-term Survival of Patients Undergoing Colorectal Cancer Surgery
- ClinicalTrials.gov ID
- NCT05412355
- Acronym / sponsor ID
- UHCT22040
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 10 Aug 2022 (estimated)
- Study completion
- 10 Oct 2022 (estimated)
- First posted
- 9 Jun 2022 (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.
Enhanced recovery after surgery (ERAS) has been reported to be associated with improved outcomes in many studies, most of which involve short-term effects. Only a few studies have reported the long-term effects of highly compliant ERAS. However, to the best of our knowledge, there are no large-scale comparisons between incomplete ERAS (compliance < 70%) and non-ERAS. The aim of this comparative study is to analyze and evaluate the long-term outcomes of incomplete ERAS in laparoscopic colorectal cancer surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Incomplete ERAS | – | Procedure: ERAS protocolIncomplete ERAS was defined as ERAS compliance < 70%. |
| Non-ERAS | – | Procedure: ERAS protocolnon-ERAS was defined as not executing any ERAS programs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In this study, we are going to collect clinical data of patients undergoing laparoscopic radical surgery from four large hospitals between August 2008 and December 2016.
Key inclusion criteria (1 listed)
- 1. age older than 18 years;2. pathological diagnosis of colorectal cancer;3. radical surgery was performed; and 4. laparoscopic surgery was performed.
Key exclusion criteria (1 listed)
- 1. ERAS compliance ≥70%; 2. open surgery; 3. switch to laparotomy after laparoscopic surgery; 4. pregnancy or lactation; 5. severe mental illness; 6. Simultaneous malignant tumors of multiple organs; 7. History of other malignant tumors; and 8. Emergency radical colorectal resection due to obstruction, perforation or bleeding.
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 |
|---|---|---|
| ERAS protocolERAS protocol is a series of procedures that enhance the recovery of surgical patients. Patients were grouped according to whether the procedure was attempted. | Procedure or surgery | Incomplete ERAS, Non-ERAS |
Primary outcome
long-term survival
Time frame: Each patient will be followed for 5 years or until death
5-year Disease free survival and overall survival
1 secondary outcome
Postoperative complications
Time frame: within 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2022.
- Individual participant dataSharing planned: Yes. After the funders finished the study,the data will be available，if approved by PI.
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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.
Xiaogang Shu, MD.，PHD. principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
2 sites 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 Enhanced Recovery After Surgery, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 2 sites in China.
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 1 inclusion and 1 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 24 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chenxing Jian, MD. (86-13959538950, ptyyjcx@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
long-term survival (time frame: Each patient will be followed for 5 years or until death). 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 24 Jun 2022.