Clinical Research on the Treatment Model of Ambulatory Surgery for Colorectal Cancer

November 24, 2024 updated by: Kai Li, First Hospital of China Medical University

Open, Parallel, Randomized Controlled, Non-inferior, Phase III Clinical Research on the Treatment Model of Ambulatory Surgery for Colorectal Cancer

To investigate the postoperative complication incidence and long-term efficacy between ambulatory surgery for colorectal cancer and traditional laparoscopic colorectal surgery in patients with colorectal tumor who are generally in good health and have sufficient organ functions。

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

352

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110000
        • Recruiting
        • First Hospital of China Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients voluntarily joined this study and signed an informed consent form；
  2. Age: 18-75 years old；
  3. The patient should have a good general condition and no serious internal medicine comorbidities (ASA classification of the American Anesthesiology Association is Grade I~III)；
  4. Complete colonoscopy and colonoscopy biopsy, and the pathology is confirmed to be adenocarcinoma/high-level intraepithelial neoplasia；
  5. Enhanced CT or MRI examination before surgery, indicating that the tumor diameter is ≤5.0 cm；
  6. Preoperative staging: cT1-3NanyM0;
  7. Strictly follow the colorectal day surgery plan, and micro-laparoscopic radical colorectal cancer treatment can be adopted；
  8. There are no contraindications for abdominal wall nerve block anesthesia or non-opiate analgesic drugs;
  9. Does not require conventional anticoagulant therapy or antiplatelet therapy；
  10. Relatives or co-residents should be able to provide 24 hours of full escort within at least 72 hours after the operation, the place of residence is not more than a 30-minute drive from the hospital, and they can understand and follow the phased treatment plan of diet, analgesic drugs, etc. after the operation.

Exclusion Criteria:

  1. Elderly patients with multiple basic diseases；
  2. Moderate to severe anemia；
  3. Severe hypoproteinemia；
  4. Diabetes that is not well controlled；
  5. Contraindications to laparoscopic surgery；
  6. Cases of emergency surgery due to acute intestinal obstruction, perforation or bleeding；
  7. Patients with distant metastases；
  8. Patients who are unwilling to sign informed consent or follow-up according to the research plan；
  9. People with a history of psychotropic drug abuse and unable to quit or have mental disorders；
  10. Patients who live alone or in psychosocial isolation, patients who cannot understand the postoperative nursing process；
  11. After the operation, the place of residence is far away from the treated hospital or patients with insufficient medical resources and inconvenient transportation；
  12. According to the judgment of the researcher, there are concomitant diseases that seriously endanger the safety of the patient or affect the completion of the patient's research.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: laparoscopic colorectal day surgery
laparoscopic colorectal day surgery in patients with colorectal tumor who are generally in good health and have sufficient organ functions
Procedure: laparoscopic colorectal day surgery
laparoscopic colorectal day surgery in patients with colorectal tumor who are generally in good health and have sufficient organ functions
Active Comparator: traditional laparoscopic colorectal surgery
traditional laparoscopic colorectal surgery in patients with colorectal tumor who are generally in good health and have sufficient organ functions
Procedure: traditional laparoscopic colorectal surgery
traditional laparoscopic colorectal surgery in patients with colorectal tumor who are generally in good health and have sufficient organ functions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recurrence-free survival (DFS)
Time Frame: From enrollment to the end of treatment at 36 months
From enrollment to the end of treatment at 36 months
Overall survival (OS)
Time Frame: From enrollment to the end of treatment at 36 months
From enrollment to the end of treatment at 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BIood system disorders
Time Frame: From enrollment to the end of treatment at 1 week

Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe but not immediately life-threatening; Grade 4: Life-threatening; Grade 5: Death.

Anemia:

Grade 1: HemogIobin (Hgb) <LLN - 10.0 g/dL; <LLN - 6.2 mmoI/L; <LLN - 100 g/L; Grade 2: Hgb <10.0 - 8.0 g/dL; <6.2 - 4.9 mmoI/L; <100 - 80g/L; Grade 3: Hgb <8.0 - 6.5 g/dL; <4.9 - 4.0 mmoI/L; <80 - 65g/L; transfusion indicated; Grade 4: Life-threatening consequences; urgent intervention indicated; Grade 5: Death.
From enrollment to the end of treatment at 1 week
Pain evaluation
Time Frame: From one hour after surgery to the end of treatment at 48 hours

Visual analogue scale (VAS) Using a ruler with 10 scales, and the two ends of the ruler are "0" and "10". 0 points indicate painless, and 10 points represent the most severe pain that is unbearable.

The patients mark the corresponding position on the ruler that can represent the degree of pain. The doctor assigns a score to the patient based on the position marked by the patient. 2-4 points represent mild pain, 5-7 points represent moderate pain, and 8-9 points represent severe pain.
From one hour after surgery to the end of treatment at 48 hours
Cardiac disorders
Time Frame: From enrollment to the end of treatment at 1 week

Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe but not immediately life-threatening; Grade 4: Life-threatening; Grade 5: Death.

Acute coronary syndrome Grade 1: - Grade 2: symptomatic, progressive angina; cardiac enzymes normaI; hemodynamicaIIy stabIe; Grade 3: symptomatic, unstabIe angina and/or acute myocardiaI infarction, cardiac enzymes abnormaI, hemodynamicaIIy stabIe; Grade 4: symptomatic, unstabIe angina and/or acute myocardiaI infarction, cardiac enzymes abnormaI, hemodynamicaIIy unstabIe.

Grade 5: Death.
From enrollment to the end of treatment at 1 week
CoIonic fistuIa
Time Frame: From enrollment to the end of treatment at 1 week

Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe but not immediately life-threatening; Grade 4: Life-threatening; Grade 5: Death.

Grade 1: Asymptomatic; cIinicaI or diagnostic observations onIy; intervention not indicated; Grade 2: symptomatic; aItered gastrointestinaI function; Grade 3: severeIy aItered GI function; boweI rest, TPN or hospitaIization indicated; eIective operative intervention indicated; Grade 4: Life-threatening; Grade 5: Death.
From enrollment to the end of treatment at 1 week
AbdominaI infection
Time Frame: From enrollment to the end of treatment at 1 week

Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe but not immediately life-threatening; Grade 4: Life-threatening; Grade 5: Death.

AbdominaI infection Grade 1: - Grade 2: - Grade 3: IV antibiotic, antifungaI, or antiviraI intervention indicated; radioIogic or operative intervention indicated; Grade 4: Life-threatening consequences; urgent intervention indicated; Grade 5: Death.
From enrollment to the end of treatment at 1 week
AnorectaI infection
Time Frame: From enrollment to the end of treatment at 1 week

Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe but not immediately life-threatening; Grade 4: Life-threatening; Grade 5: Death.

AnorectaI infection Grade 1: LocaIized; IocaI intervention indicated; Grade 2: OraI intervention indicated (e.g. , antibiotic, antifungaI, antiviraI); Grade 3: IV antibiotic, antifungaI, or antiviraI intervention indicated; radioIogic, endoscopic, or operative intervention indicated; Grade 4: Life-threatening consequences; urgent intervention indicated; Grade 5: Death.
From enrollment to the end of treatment at 1 week
Fever
Time Frame: From enrollment to the end of treatment at 1 week

Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe but not immediately life-threatening; Grade 4: Life-threatening; Grade 5: Death.

Fever Grade 1: 38.0 - 39.0 degrees C (100.4 - 102.2 degrees F); Grade 2: >39.0 - 40.0 degrees C (102.3 - 104.0 degrees F); Grade 3: >40.0 degrees C (>104.0 degrees F) for <=24 hrs; Grade 4: >40.0 degrees C (>104.0 degrees F) for >24 hrs; Grade 5: Death.
From enrollment to the end of treatment at 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Hospital of China Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Estimated)

March 31, 2026

Study Completion (Estimated)

March 31, 2029

Study Registration Dates

First Submitted

September 9, 2024

First Submitted That Met QC Criteria

October 9, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Estimated)

November 27, 2024

Last Update Submitted That Met QC Criteria

November 24, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FirstHCMU_ambulatory_surgery

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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