Hyper-ERAS Program for Highly Selective Colorectal Cancer Patients
Hyper Enhanced Recovery After Surgery (Hyper-ERAS) Program for Highly Selective Colorectal Cancer Patients Undergoing Laparoscopic Surgery
1 other identifier
interventional
160
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable colorectal-cancer
Started Jun 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2023
CompletedFirst Submitted
Initial submission to the registry
February 5, 2024
CompletedFirst Posted
Study publicly available on registry
February 13, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2025
CompletedFebruary 13, 2024
February 1, 2024
2 years
February 5, 2024
February 12, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
30-day overall complication rate
The primary endpoint was the 30-day overall complication rate.
30 days after surgery
Secondary Outcomes (2)
Severe complications (CD≥IIIb) rate, within 30 days after surgery
30 days after surgery
The rehospitalization rate within 30 days after surgery
30 days after surgery
Study Arms (3)
Group A:Hyper-ERAS(Length of Postoperative Hospital Stay<48h)
EXPERIMENTALPatients treated with the Hyper-ERAS rehabilitation protocol and discharged within 48 hours were in group A.
Group B:Hyper-ERAS(LOPS>48h)
EXPERIMENTALPatients treated with the ERAS rehabilitation protocol and discharged in more than 48 hours were in group B.
Group C:Control group
NO INTERVENTIONPatients eligible but not treated with the Hyper-ERAS rehabilitation protocol during the same period were in group C.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University Cancer Hospital & Institute
Beijing, Haidian District, 100142, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Unit III & Ostomy Service, Gastrointestinal Cancer Center
Study Record Dates
First Submitted
February 5, 2024
First Posted
February 13, 2024
Study Start
June 1, 2023
Primary Completion
June 1, 2025
Study Completion
August 1, 2025
Last Updated
February 13, 2024
Record last verified: 2024-02