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

NCT ID: NCT04646915

Last Updated: 2020-11-30

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-12-15
• Study Completion Date: 2022-02-28

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.

Conditions

Colorectal Cancer

Keywords

day surgery; laparoscopic colectomy; laparoscopic anterior resection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with CuRC undergoing day surgery

Patients with CuRC undergoing laparoscopic colectomy or anterior resection in day surgery center.

Day surgery

Intervention Type: OTHER

Patients with CuRC who meet the standards will be assigned to day surgery center for surgery

Interventions

Day surgery

Patients with CuRC who meet the standards will be assigned to day surgery center for surgery

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

West China Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ziqiang Wang,MD

Clinical professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ziqiang Wang

Role: STUDY_CHAIR

Department of Gastrointestinal Surgery, West China Hospital, Sichuan University

Locations

Guoxue Road 37#,West China Hospital

Chengdu, Sichuan, China

Countries

China

Other Identifiers

DS-CuRC-2020

Identifier Type: -

Identifier Source: org_study_id