Colorectal CancerNCT06256315
Hyper-ERAS Program for Highly Selective Colorectal Cancer Patients
A study testing Hyper-ERAS Program in people with Colorectal Cancer and ERAS, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
This clinical trial aims to explore the safety and effectiveness of the Hyper-ERAS rehabilitation protocol for colorectal cancer patients and the feasibility of discharge within 48 hours. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Colorectal Cancer, ERAS
- What is being tested?
- Hyper-ERAS Program
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 1 Aug 2025
- Phase
- Interventional
- 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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed colorectal cancer.
- The position of the anastomosis is above the peritoneal reflection.
- Age range from 18 to 79 years old.
- No surgical contraindications.
- The patient has good compliance and can understand the concept of rapid recovery.
- Possess basic nursing conditions outside the hospital, and can arrive at the hospital within 30 minutes after discharge.
Who cannot join
- The exclusion criteria consisted of three parts: the first exclusion at enrollment, the second exclusion after surgery, and the third exclusion before discharge, corresponding to three exclusion criteria. 1st: Exclusion criteria at enrollment: 1). ASA grade ≥ grad 4. 2). Having previous surgical history, complex surgery, or combined/multiple organ resection with large trauma. 3). patients with complete obstruction or obvious intestinal edema and dilatation. 4). application of high-dose hormones, immunosuppressants, and preoperative radiotherapy. 5). Emergency surgery. 6). Patients with self-care difficulties for physical or mental reasons. 7). Pregnant patients. 8). to accept other studies simultaneously. 9). Inability to understand or accept the concept of enhanced recovery after surgery; 2nd: Postoperative exclusion criteria: 1). Adverse events occurred during preoperative preparation, such as perforation, massive bleeding, obstruction, fever, etc. 2). Adverse events occurred during the operation, such as intraoperative massive bleeding (≥400ml), unsatisfactory anastomosis, intraoperative perforation, unstable vital signs, etc. 3). Have any other conditions deemed ineligible for enrollment; 3rd: Exclusion criteria before discharge: 1). Body temperature above 37.5℃. 2) The food intake cannot meet the basic physiological needs, such as liquid food < 1000ml/ day. 3) with obvious abdominal distension, vomiting, cough and expectoration, dizziness, chest tightness, and other discomfort. 4) patients with abnormal laboratory indicators and abnormal nature of drainage fluid requiring hospitalization, such as bleeding, infection, leakage, etc. 5). Poor recovery of field activities and inability to care for themselves. 6). Have any other conditions deemed unsuitable for discharge. 7). Refusal to discharge.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Cancer Hospital & Institute
Beijing, Haidian District, 100142
Lin Wang, M.D., +8613910975011, wanglinmd@foxmail.com
Changlong Li, M.D., +8618954156864, vip2nd@163.com
About this study
Official title: Hyper Enhanced Recovery After Surgery (Hyper-ERAS) Program for Highly Selective Colorectal Cancer Patients Undergoing Laparoscopic Surgery
This clinical trial aims to explore the safety and effectiveness of the Hyper-ERAS rehabilitation protocol for colorectal cancer patients and the feasibility of discharge within 48 hours.
Read the detailed description
The Hype-ERAS protocol includes preoperative education, intraoperative quality control, postoperative preventive analgesia, early ambulation, early recovery of diet, early removal of drainage tube, urinary catheter, and gastric tube, discharge within 48 hours after surgery, and standardized follow-up outside the hospital. Patients treated with the Hyper-ERAS rehabilitation protocol and discharged within 48 hours were in group A. Patients who were treated with Hyper-ERAS protocol and had a postoperative hospital stay of more than 48 hours were classified as group B. Patients eligible but not treated with the Hyper-ERAS rehabilitation protocol during the same period were in group C (Control group). The postoperative recovery of each group was compared to explore the safety and efficacy of Hyper-ERAS rehabilitation program in patients with colorectal cancer.
- Conditions
- Colorectal Cancer, ERAS
- Being tested
- Hyper-ERAS Program
- Keywords
- Colorectal Cancer, Hyper-ERAS, Super Accelerated Rehabilitation Surgery, Rapid Rehabilitation, Perioperative Management, ERAS2.0
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyper-ERAS ProgramProcedure or surgery
Patients who met the inclusion criteria were treated with Hype-ERAS protocol, including preoperative education, intraoperative quality control, postoperative preventive analgesia, early ambulation, early recovery of diet, early removal of the drainage tube, urinary catheter, and gastric tube, and discharge within 48 hours or more than 48 hours safter surgery, and closely and standardized follow-up outside the hospital.
| Study group | Role | What they receive |
|---|---|---|
| Group A:Hyper-ERAS(Length of Postoperative Hospital Stay<48h) | Experimental | Patients treated with the Hyper-ERAS rehabilitation protocol and discharged within 48 hours were in group A. Receives: Procedure: Hyper-ERAS Program |
| Group B:Hyper-ERAS(LOPS>48h) | Experimental | Patients treated with the ERAS rehabilitation protocol and discharged in more than 48 hours were in group B. Receives: Procedure: Hyper-ERAS Program |
| Group C:Control group | No intervention | Patients eligible but not treated with the Hyper-ERAS rehabilitation protocol during the same period were in group C. |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day overall complication rate
The primary endpoint was the 30-day overall complication rate.
Measured: 30 days after surgery
Secondary outcomes (2)
Severe complications (CD≥IIIb) rate, within 30 days after surgery
Severe complications (CD≥IIIb) rate
Measured: 30 days after surgery
The rehospitalization rate within 30 days after surgery
Measured: 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 posted13 Feb 2024
- Study start1 Jun 2023
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin Wang, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06256315
- Sponsor's protocol ID
- PKUCH Hyper-ERAS research
- Status last verified
- Feb 2024
- First submitted
- 5 Feb 2024
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyper Enhanced Recovery After Surgery (Hyper-ERAS) Program for Highly Selective Colorectal Cancer Patients Undergoing Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT06256315
- Acronym / sponsor ID
- PKUCH Hyper-ERAS research
- Conditions
- Colorectal Cancer, ERAS
- Keywords
- Colorectal Cancer, Hyper-ERAS, Super Accelerated Rehabilitation Surgery, Rapid Rehabilitation, Perioperative Management, ERAS2.0
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 13 Feb 2024 (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.
This clinical trial aims to explore the safety and effectiveness of the Hyper-ERAS rehabilitation protocol for colorectal cancer patients and the feasibility of discharge within 48 hours.
Detailed description
The Hype-ERAS protocol includes preoperative education, intraoperative quality control, postoperative preventive analgesia, early ambulation, early recovery of diet, early removal of drainage tube, urinary catheter, and gastric tube, discharge within 48 hours after surgery, and standardized follow-up outside the hospital. Patients treated with the Hyper-ERAS rehabilitation protocol and discharged within 48 hours were in group A. Patients who were treated with Hyper-ERAS protocol and had a postoperative hospital stay of more than 48 hours were classified as group B. Patients eligible but not treated with the Hyper-ERAS rehabilitation protocol during the same period were in group C (Control group). The postoperative recovery of each group was compared to explore the safety and efficacy of Hyper-ERAS rehabilitation program in patients with colorectal cancer.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A:Hyper-ERAS(Length of Postoperative Hospital Stay<48h) | Experimental | Procedure: Hyper-ERAS ProgramPatients treated with the Hyper-ERAS rehabilitation protocol and discharged within 48 hours were in group A. |
| Group B:Hyper-ERAS(LOPS>48h) | Experimental | Procedure: Hyper-ERAS ProgramPatients treated with the ERAS rehabilitation protocol and discharged in more than 48 hours were in group B. |
| Group C:Control group | No intervention | –Patients eligible but not treated with the Hyper-ERAS rehabilitation protocol during the same period were in group C. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Pathologically confirmed colorectal cancer.
- The position of the anastomosis is above the peritoneal reflection.
- Age range from 18 to 79 years old.
- No surgical contraindications.
- The patient has good compliance and can understand the concept of rapid recovery.
Key exclusion criteria (1 listed)
- The exclusion criteria consisted of three parts: the first exclusion at enrollment, the second exclusion after surgery, and the third exclusion before discharge, corresponding to three exclusion criteria. 1st: Exclusion criteria at enrollment: 1). ASA grade ≥ grad 4. 2). Having previous surgical history, complex surgery, or combined/multiple organ resection with large trauma. 3). patients with complete obstruction or obvious intestinal edema and dilatation. 4). application of high-dose hormones, immunosuppressants, and preoperative radiotherapy. 5). Emergency surgery. 6). Patients with self-care difficulties for physical or mental reasons. 7). Pregnant patients. 8). to accept other studies simultaneously. 9). Inability to understand or accept the concept of enhanced recovery after surgery; 2nd: Postoperative exclusion criteria: 1). Adverse events occurred during preoperative preparation, such as perforation, massive bleeding, obstruction, fever, etc. 2). Adverse events occurred during the operation, such as intraoperative massive bleeding (≥400ml), unsatisfactory anastomosis, intraoperative perforation, unstable vital signs, etc. 3). Have any other conditions deemed ineligible for enrollment; 3rd: Exclusion criteria before discharge: 1). Body temperature above 37.5℃. 2) The food intake cannot meet the basic physiological needs, such as liquid food < 1000ml/ day. 3) with obvious abdominal distension, vomiting, cough and expectoration, dizziness, chest tightness, and other discomfort. 4) patients with abnormal laboratory indicators and abnormal nature of drainage fluid requiring hospitalization, such as bleeding, infection, leakage, etc. 5). Poor recovery of field activities and inability to care for themselves. 6). Have any other conditions deemed unsuitable for discharge. 7). Refusal to discharge.
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 |
|---|---|---|
| Hyper-ERAS ProgramPatients who met the inclusion criteria were treated with Hype-ERAS protocol, including preoperative education, intraoperative quality control, postoperative preventive analgesia, early ambulation, early recovery of diet, early removal of the drainage tube, urinary catheter, and gastric tube, and discharge within 48 hours or more than 48 hours safter surgery, and closely and standardized follow-up outside the hospital. | Procedure or surgery | Group A:Hyper-ERAS(Length of Postoperative Hospital Stay<48h), Group B:Hyper-ERAS(LOPS>48h) |
Primary outcome
30-day overall complication rate
Time frame: 30 days after surgery
The primary endpoint was the 30-day overall complication rate.
2 secondary outcomes
Severe complications (CD≥IIIb) rate, within 30 days after surgery
Time frame: 30 days after surgery
The rehospitalization rate within 30 days after surgery
Time frame: 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 13 Feb 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyper-ERAS Program in people with Colorectal Cancer and ERAS, run by Peking University Cancer Hospital & Institute at 1 site 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 6 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 13 Feb 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 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 Changlong Li (+861088196086, vip2nd@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day overall complication rate (time frame: 30 days after surgery). 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 13 Feb 2024.