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

Colorectal Cancer Clinical Trial

Official title:

Evaluation of Short-term Outcomes of Laparoscopic Radical Resection for Patients With Colon and Upper Rectum in Day Surgery Center

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04646915
• Other study ID #: DS-CuRC-2020
• Status: Enrolling by invitation
• Start date: December 15, 2019
• Est. completion date: February 28, 2022

Study information

• Verified date: November 2020
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 120
• Est. completion date: February 28, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 >? 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)

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• Day surgery
Patients with CuRC who meet the standards will be assigned to day surgery center for surgery

Locations

Country	Name	City	State
China	Guoxue Road 37#,West China Hospital	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of transfer to inpatient ward	The incidence of patients who did not transfer to community hospital according to the plan after operation, and the causes of this situation.	one month after operation
Secondary	operation duration time	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	during the operation
Secondary	Blood loss	intraoperative blood loss	during the operation
Secondary	Postoperative complications	including incision infection,anastomotic leakage,respiratory infection, postoperative bleeding, and so on.	3 months after the surgery
Secondary	Length of Hospital stay (LOS)	Time from admission to discharge	3 months after admission
Secondary	Costs of hospital expense	Expense for disease treatment during hospitalization	3 months after admission
Secondary	Readmission rate	The proportion of patients who are re-hospitalized for postoperative adverse events within 90 days after discharge in all subjects.	90 days after surgery
Secondary	Mortality	Death rate within 90 days after surgery in all patients after operation	90 days after surgery