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NCT Number: NCT06637215

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。

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Key information

Conditions

Colorectal Carcinoma Colonic Diseases Colorectal Neoplasms Day Surgery Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

First Hospital of China Medical University

Shenyang, Liaoning, 110000, China

Location status: Recruiting

Location contact

Kai Li, MD

CONTACT

[email protected]

8613998245233

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients voluntarily joined this study and signed an informed consent form；
  • Age: 18-75 years old；
  • 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)；
  • Complete colonoscopy and colonoscopy biopsy, and the pathology is confirmed to be adenocarcinoma/high-level intraepithelial neoplasia；
  • Enhanced CT or MRI examination before surgery, indicating that the tumor diameter is ≤5.0 cm；
  • Preoperative staging: cT1-3NanyM0;
  • Strictly follow the colorectal day surgery plan, and micro-laparoscopic radical colorectal cancer treatment can be adopted；
  • There are no contraindications for abdominal wall nerve block anesthesia or non-opiate analgesic drugs;
  • Does not require conventional anticoagulant therapy or antiplatelet therapy；
  • 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

  • Elderly patients with multiple basic diseases；
  • Moderate to severe anemia；
  • Severe hypoproteinemia；
  • Diabetes that is not well controlled；
  • Contraindications to laparoscopic surgery；
  • Cases of emergency surgery due to acute intestinal obstruction, perforation or bleeding；
  • Patients with distant metastases；
  • Patients who are unwilling to sign informed consent or follow-up according to the research plan；
  • People with a history of psychotropic drug abuse and unable to quit or have mental disorders；
  • Patients who live alone or in psychosocial isolation, patients who cannot understand the postoperative nursing process；
  • After the operation, the place of residence is far away from the treated hospital or patients with insufficient medical resources and inconvenient transportation；
  • 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.

Treatment and study plan

laparoscopic colorectal day surgery

Procedure

laparoscopic colorectal day surgery in patients with colorectal tumor who are generally in good health and have sufficient organ functions

traditional laparoscopic colorectal surgery

Procedure

traditional laparoscopic colorectal surgery in patients with colorectal tumor who are generally in good health and have sufficient organ functions

Primary outcomes

  1. Recurrence-free survival (DFS)

    Time frame: From enrollment to the end of treatment at 36 months

  2. Overall survival (OS)

    Time frame: From enrollment to the end of treatment at 36 months

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kai Li

CONTACT

[email protected]

8613998245233

Sponsors and collaborators

Lead sponsor

First Hospital of China Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2029
First posted
Oct 15, 2024
Registry last updated
Nov 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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