Hyper-ERAS Program for Highly Selective Colorectal Cancer Patients

Not Applicable

Recruiting

• Conditions: ERAS; Colorectal Cancer
• Interventions: Procedure: Hyper-ERAS Program

• Registration Number: NCT06256315
• Lead Sponsor: Peking University Cancer Hospital & Institute

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.

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 Timeline

• Study Start: 2023-06-01
• Status Verified: 2024-02
• Study First Submitted: 2024-02-05
• Study First Submitted QC: 2024-02-12
• Last Update Submitted: 2024-02-12
• Study First Posted: 2024-02-13
• Last Update Posted: 2024-02-13
• Primary Completion: 2025-06-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B:Hyper-ERAS(LOPS>48h)	Hyper-ERAS Program	Patients treated with the ERAS rehabilitation protocol and discharged in more than 48 hours were in group B.
Group A:Hyper-ERAS(Length of Postoperative Hospital Stay<48h)	Hyper-ERAS Program	Patients treated with the Hyper-ERAS rehabilitation protocol and discharged within 48 hours were in group A.

Primary Outcome Measures

Name	Time	Method
30-day overall complication rate	30 days after surgery	The primary endpoint was the 30-day overall complication rate.

Secondary Outcome Measures

Name	Time	Method
Severe complications (CD≥IIIb) rate, within 30 days after surgery	30 days after surgery	Severe complications (CD≥IIIb) rate
The rehospitalization rate within 30 days after surgery	30 days after surgery

Trial Locations

Locations (1)

Peking University Cancer Hospital & Institute; 🇨🇳 Beijing, Haidian District, China