Evaluation of Short-term Outcomes of Day Surgery for Patients With CuRC

• Conditions: Colorectal Cancer
• Interventions: Other: Day surgery

• Registration Number: NCT04646915
• Lead Sponsor: West China Hospital

Brief Summary

To evaluate the feasibility and safety of laparoscopic colectomy and anterior resection for patients with colon/upper rectal cancer (CuRC) in day surgery center. Patients with colon or upper rectal cancer who meet the standards of day surgery will be enrolled, and laparoscopic radical resection of tumor will be performed in day surgery center. Perioperative outcomes of these patients and reasons for transferring to inpatient ward will be recorded prospectively.

Detailed Description

At present, with the development of laparoscopic surgery and the application of rapid rehabilitation, colorectal surgery has made great progress . At the same time, the application of evidence-based surgery and multimodal anesthesia in postoperative rehabilitation has accelerated the postoperative recovery. Moreover, several previous studies have shown that the implementation of ambulatory colorectal surgery can reduce the incidence of postoperative complications and shorten hospital stay. With the continuous development of rehabilitation surgery, the hospitalization time of colorectal surgery has been gradually shortened. In addition, studies had preliminarily proved the feasibility, safety and repeatability of outpatient colectomy and showed that 30% of patients with elective colectomy can be completed in outpatient department.

Therefore, the investigators designed the clinical pathway of day surgery for patients screened by outpatient department, so that these patients can complete laparoscopic radical resection of colon cancer or high rectal cancer in the day surgery center.

The aim of this study is to evaluate the feasibility and safety of day surgery center for patients with colon/upper rectal cancer (CuRC). Patients meet the inclusion criteria and exclusion criteria will be assigned to day surgery center to perform radically laparoscopic colectomy or anterior resection. Outcomes of interests including incidence of transfer to inpatient ward, readmission, perioperative adverse events will be recorded prospectively.

Study Timeline

• Study Start: 2019-12-15
• Status Verified: 2020-11
• Study First Submitted: 2020-11-11
• Study First Submitted QC: 2020-11-21
• Last Update Submitted: 2020-11-21
• Study First Posted: 2020-11-30
• Last Update Posted: 2020-11-30
• Primary Completion: 2021-12-31
• Study Completion: 2022-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Patients under 65 years old with colorectal cancer or patients older than 65 years assessed by anesthesiologist that their physical conditions were excellent;
2. Tumor located higher than 10cm by colonoscopy, and It is expected that the distal resection margin is above the peritoneal reflexes;
3. Tumor location was diagnosed clearly by abdominal CT, no severe local invasion required extensive resection, and no intraoperative colonoscopy was needed to determine the tumor site;
4. No distant metastasis assessed by preoperative imaging examination ；
5. There was no special abnormality in blood routine, blood biochemistry, blood coagulation, electrocardiogram and pulmonary function, and anesthesiologist assessed that the patient was safe for day surgery

Exclusion Criteria

1. Patients with distant metastasis
2. Patients with ASA grade >Ⅲ and high risk in perioperative period are expected
3. Tumor was too small to clearly showed by abdominal CT, and Intraoperative colonoscopy is needed.
4. Patients who need neoadjuvant therapy (preoperative chemoradiotherapy)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with CuRC undergoing day surgery	Day surgery	Patients with CuRC undergoing laparoscopic colectomy or anterior resection in day surgery center.

Primary Outcome Measures

Name	Time	Method
Incidence of transfer to inpatient ward	one month after operation	The incidence of patients who did not transfer to community hospital according to the plan after operation, and the causes of this situation.

Secondary Outcome Measures

Name	Time	Method
Mortality	90 days after surgery	Death rate within 90 days after surgery in all patients after operation
Length of Hospital stay (LOS)	3 months after admission	Time from admission to discharge
Blood loss	during the operation	intraoperative blood loss
Readmission rate	90 days after surgery	The proportion of patients who are re-hospitalized for postoperative adverse events within 90 days after discharge in all subjects.
operation duration time	during the operation	From the beginning of the skin incision to the end of the last incision was From the beginning of the skin incision to the end of the suture of last incision
Postoperative complications	3 months after the surgery	including incision infection，anastomotic leakage，respiratory infection, postoperative bleeding, and so on.
Costs of hospital expense	3 months after admission	Expense for disease treatment during hospitalization

Trial Locations

Locations (1)

Guoxue Road 37#,West China Hospital; 🇨🇳 Chengdu, Sichuan, China