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

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer; ERAS
• Intervention / Treatment: Procedure: Hyper-ERAS Program

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 Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lin Wang, M.D.; Phone Number: +8613910975011; Email: wanglinmd@foxmail.com
• Study Contact Backup: Name: Changlong Li; Phone Number: +861088196086; Email: vip2nd@163.com

Study Locations

• China
  • Haidian District
    • Beijing, Haidian District, China, 100142
      • Recruiting
      • Peking University Cancer Hospital & Institute
      • Contact: Lin Wang, M.D.; Phone Number: +8613910975011; Email: wanglinmd@foxmail.com
      • Principal Investigator: Lin Wang, M.D.
      • Contact: Changlong Li, M.D.; Phone Number: +8618954156864; Email: vip2nd@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Pathologically confirmed colorectal cancer.
2. The position of the anastomosis is above the peritoneal reflection.
3. Age range from 18 to 79 years old.
4. No surgical contraindications.
5. The patient has good compliance and can understand the concept of rapid recovery.
6. Possess basic nursing conditions outside the hospital, and can arrive at the hospital within 30 minutes after discharge.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A:Hyper-ERAS(Length of Postoperative Hospital Stay<48h); Patients treated with the Hyper-ERAS rehabilitation protocol and discharged within 48 hours were in group A.	Procedure: Hyper-ERAS Program; 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.
Experimental: Group B:Hyper-ERAS(LOPS>48h); Patients treated with the ERAS rehabilitation protocol and discharged in more than 48 hours were in group B.	Procedure: Hyper-ERAS Program; 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.
No Intervention: Group C:Control group; Patients eligible but not treated with the Hyper-ERAS rehabilitation protocol during the same period were in group C.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day overall complication rate	The primary endpoint was the 30-day overall complication rate.	30 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severe complications (CD≥IIIb) rate, within 30 days after surgery	Severe complications (CD≥IIIb) rate	30 days after surgery
The rehospitalization rate within 30 days after surgery		30 days after surgery

Collaborators and Investigators

• Sponsor: Peking University Cancer Hospital & Institute

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: February 5, 2024
• First Submitted That Met QC Criteria: February 12, 2024
• First Posted (Estimated): February 13, 2024

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Colorectal Cancer; Hyper-ERAS; Super Accelerated Rehabilitation Surgery; Rapid Rehabilitation; Perioperative Management; ERAS2.0
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: PKUCH Hyper-ERAS research

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No