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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04646915
Enrollment
120
Registered
2020-11-30
Start date
2019-12-15
Completion date
2022-02-28
Last updated
2020-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

day surgery, laparoscopic colectomy, laparoscopic anterior resection

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.

Interventions

OTHERDay surgery

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

Sponsors

West China Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Incidence of transfer to inpatient wardone month after operationThe incidence of patients who did not transfer to community hospital according to the plan after operation, and the causes of this situation.

Secondary

MeasureTime frameDescription
Blood lossduring the operationintraoperative blood loss
Postoperative complications3 months after the surgeryincluding incision infection,anastomotic leakage,respiratory infection, postoperative bleeding, and so on.
Length of Hospital stay (LOS)3 months after admissionTime from admission to discharge
operation duration timeduring the operationFrom 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
Readmission rate90 days after surgeryThe proportion of patients who are re-hospitalized for postoperative adverse events within 90 days after discharge in all subjects.
Mortality90 days after surgeryDeath rate within 90 days after surgery in all patients after operation
Costs of hospital expense3 months after admissionExpense for disease treatment during hospitalization

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026