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Colorectal CarcinomaNCT06637215

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

A study testing laparoscopic colorectal day surgery and traditional laparoscopic colorectal surgery in people with Colorectal Carcinoma and Day Surgery, run by First Hospital of China Medical University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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。 Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Colorectal Carcinoma, Day Surgery
What is being tested?
laparoscopic colorectal day surgery and traditional laparoscopic colorectal surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
352 participants
Where
1 siteChina
Study dates
1 Nov 2023to 31 Mar 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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；
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kai Li contact

8613998245233

cmu_likai@163.com

China1 site, 1 recruiting

  • First Hospital of China Medical University

    Shenyang, Liaoning, 110000

    Kai Li, MD, 8613998245233, cmu_likai@163.com

    Recruiting

Other trials in China

About this study

Official title: 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。

Being tested
laparoscopic colorectal day surgery, traditional laparoscopic colorectal surgery
Keywords
Colorectal cancer, Day surgery, Laparoscope
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • laparoscopic colorectal day surgeryProcedure or surgery

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

  • traditional laparoscopic colorectal surgeryProcedure or surgery

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

Study groups in NCT06637215
Study groupRoleWhat they receive
laparoscopic colorectal day surgeryExperimentallaparoscopic colorectal day surgery in patients with colorectal tumor who are generally in good health and have sufficient organ functions
Receives: Procedure: laparoscopic colorectal day surgery
traditional laparoscopic colorectal surgeryActive comparatortraditional laparoscopic colorectal surgery in patients with colorectal tumor who are generally in good health and have sufficient organ functions
Receives: Procedure: traditional laparoscopic colorectal surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recurrence-free survival (DFS)

    Measured: From enrollment to the end of treatment at 36 months

  2. Overall survival (OS)

    Measured: From enrollment to the end of treatment at 36 months

Secondary outcomes (7)

  1. BIood system disorders

    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.

    Measured: From enrollment to the end of treatment at 1 week

  2. Pain evaluation

    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.

    Measured: From one hour after surgery to the end of treatment at 48 hours

  3. Cardiac disorders

    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.

    Measured: From enrollment to the end of treatment at 1 week

  4. CoIonic fistuIa

    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.

    Measured: From enrollment to the end of treatment at 1 week

  5. AbdominaI infection

    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.

    Measured: From enrollment to the end of treatment at 1 week

  6. AnorectaI infection

    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.

    Measured: From enrollment to the end of treatment at 1 week

  7. Fever

    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.

    Measured: From enrollment to the end of treatment at 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2024
  2. Study start1 Nov 2023
  3. Primary completion31 Mar 2026 (estimated)
  4. Study completion31 Mar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
352 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06637215
Sponsor's protocol ID
FirstHCMU_ambulatory_surgery
Status last verified
Apr 2024
First submitted
9 Sep 2024
Last updated
27 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing laparoscopic colorectal day surgery and traditional laparoscopic colorectal surgery in people with Colorectal Carcinoma and Day Surgery, run by First Hospital of China Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kai Li (8613998245233, cmu_likai@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence-free survival (DFS) (time frame: From enrollment to the end of treatment at 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06637215.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.

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