Hyper-ERAS program for colorectal cancer patients

Hyper Enhanced Recovery After Surgery (Hyper-ERAS) Program for Highly Selective Colorectal Cancer Patients Undergoing Laparoscopic Surgery

This study tests a new recovery program for colorectal cancer patients after surgery to see if it helps them heal faster and leave the hospital sooner.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 18 Years to 79 Years
• Sex: All
• Sponsor: Peking University Cancer Hospital & Institute (other)
• Locations: 1 site (Beijing, Haidian District)
• Trial ID: NCT06256315 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and effectiveness of the Hyper-ERAS rehabilitation protocol for patients undergoing surgery for colorectal cancer. The protocol includes preoperative education, intraoperative quality control, and various postoperative measures aimed at facilitating rapid recovery, such as early ambulation and diet resumption. Patients are categorized based on their length of hospital stay post-surgery, allowing for a comparison of recovery outcomes between those discharged within 48 hours and those who stayed longer. The goal is to determine the feasibility and benefits of this accelerated rehabilitation approach.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 79 with pathologically confirmed colorectal cancer and no surgical contraindications.

Not a fit: Patients with ASA grade ≥ 4, complex surgical histories, or those requiring high-dose hormones or immunosuppressants may not benefit from this study.

Why it matters

Potential benefit: If successful, this program could significantly reduce hospital stays and improve recovery times for colorectal cancer patients.

How similar studies have performed: Other studies have shown promising results with enhanced recovery protocols in surgical patients, indicating potential success for this approach.

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.

Where this trial is running

Beijing, Haidian District

• Peking University Cancer Hospital & Institute — Beijing, Haidian District, China (RECRUITING)

Study contacts

• Study coordinator: Changlong Li

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