Hyper-ERAS Program for Highly Selective Colorectal Cancer Patients

Trial Title: Hyper-ERAS Program for Highly Selective Colorectal Cancer Patients

NCT ID: NCT06256315

Condition: Colorectal Cancer
ERAS

Conditions: Official terms:
Colorectal Neoplasms

Conditions: Keywords:
Colorectal Cancer
Hyper-ERAS
Super Accelerated Rehabilitation Surgery
Rapid Rehabilitation
Perioperative Management
ERAS2.0

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: Single (Participant)

Intervention:

Intervention type: Procedure
Intervention name: Hyper-ERAS Program
Description: 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.
Arm group label: Group A:Hyper-ERAS(Length of Postoperative Hospital Stay<48h)
Arm group label: Group B:Hyper-ERAS(LOPS>48h)

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.

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: 79 Years

Healthy volunteers: No

Locations:

Facility:
Name: Peking University Cancer Hospital & Institute

Address:
City: Beijing
Zip: 100142
Country: China

Status: Recruiting

Contact:
Last name: Lin Wang, M.D.

Phone: +8613910975011
Email: wanglinmd@foxmail.com

Contact backup:
Last name: Changlong Li, M.D.

Phone: +8618954156864
Email: vip2nd@163.com

Investigator:
Last name: Lin Wang, M.D.
Email: Principal Investigator

Start date: June 1, 2023

Completion date: August 1, 2025

Lead sponsor:
Agency: Peking University Cancer Hospital & Institute
Agency class: Other

Source: Peking University Cancer Hospital & Institute

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06256315