Clinical trial NCT04646915: Evaluation of Short-term Outcomes of Day Surgery for Patients With CuRC
Official title: Evaluation of Short-term Outcomes of Laparoscopic Radical Resection for Patients With Colon and Upper Rectum in Day Surgery Center
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer
Keywords: day surgery
laparoscopic colectomy
laparoscopic anterior resection
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2020-11-30
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with CuRC undergoning laparoscopic radical colectomy or anterior resection in day surgery center.

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.

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)

Primary outcomes:
measure: Incidence of transfer to inpatient ward
timeFrame: one month after operation
Secondary outcomes:
measure: operation duration time
timeFrame: during the operation
measure: Blood loss
timeFrame: during the operation
measure: Postoperative complications
timeFrame: 3 months after the surgery
measure: Length of Hospital stay (LOS)
timeFrame: 3 months after admission
measure: Costs of hospital expense
timeFrame: 3 months after admission
measure: Readmission rate
timeFrame: 90 days after surgery
measure: Mortality
timeFrame: 90 days after surgery
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Guoxue Road 37#,West China Hospital
state: Sichuan
Study officials:
affiliation: Department of Gastrointestinal Surgery, West China Hospital, Sichuan University
name: Ziqiang Wang
role: STUDY_CHAIR
References: