Clinical trial NCT06256315: Hyper-ERAS Program for Highly Selective Colorectal Cancer Patients
Official title: Hyper Enhanced Recovery After Surgery (Hyper-ERAS) Program for Highly Selective Colorectal Cancer Patients Undergoing Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Cancer
ERAS
Keywords: Colorectal Cancer
Hyper-ERAS
Super Accelerated Rehabilitation Surgery
Rapid Rehabilitation
Perioperative Management
ERAS2.0
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2024-02-13
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: 30-day overall complication rate
timeFrame: 30 days after surgery
Secondary outcomes:
measure: Severe complications (CD≥IIIb) rate, within 30 days after surgery
timeFrame: 30 days after surgery
measure: The rehospitalization rate within 30 days after surgery
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital & Institute
state: Haidian District
Study officials:
References: