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

NCT04646915 | Unknown DMC

• 1 other identifier: DS-CuRC-2020
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

day surgery; laparoscopic colectomy; laparoscopic anterior resection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• operation duration time

  during the operation

• Blood loss

  during the operation

• Postoperative complications

  3 months after the surgery

• Length of Hospital stay (LOS)

  3 months after admission

• Costs of hospital expense

  3 months after admission

Study Arms (1)

Patients with CuRC undergoing day surgery

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

Other: Day surgery

Interventions

Day surgery OTHER

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

Patients with CuRC undergoing day surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients under 65 years old with colorectal cancer or patients older than 65 years assessed by anesthesiologist that their physical conditions were excellent;
• Tumor located higher than 10cm by colonoscopy, and It is expected that the distal resection margin is above the peritoneal reflexes;
• 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;
• No distant metastasis assessed by preoperative imaging examination ；
• 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

You may not qualify if:

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

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

Guoxue Road 37#,West China Hospital

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Ambulatory Surgical Procedures

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Ziqiang Wang

  Department of Gastrointestinal Surgery, West China Hospital, Sichuan University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Study Record Dates

• First Submitted: November 11, 2020
• First Posted: November 30, 2020
• Study Start: December 15, 2019
• Primary Completion: December 31, 2021
• Study Completion: February 28, 2022
• Last Updated: November 30, 2020

Record last verified: 2020-11

Locations

CN (1)