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RecruitingNCT06637215Updated Nov 27, 2024

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

An interventional study of laparoscopic colorectal day surgery and traditional laparoscopic colorectal surgery in Colorectal Carcinoma and Day Surgery, sponsored by First Hospital of China Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-11-27.

Sponsored by First Hospital of China Medical University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2026, 6 months ago, but the record still lists the study as recruiting.
  • Registered 10 months after the study started (first participant enrolled Nov 2023, registered Sep 2024).
  • Started Nov 2023; still recruiting 2 years 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
352
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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。

02

Conditions studied

  • Colorectal Carcinoma
  • Day Surgery

Keywords

  • Colorectal cancer
  • Day surgery
  • Laparoscope
03

In context

Colorectal Neoplasms

5,738 studies on the registry are indexed under Colorectal Neoplasms; 1,481 are open to participants now.

This study's planned enrollment of 352 is above the median of 77 across 4,222 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

First Hospital of China Medical University is the lead sponsor of 61 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
352 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • Procedurelaparoscopic colorectal day surgery

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

  • Proceduretraditional laparoscopic colorectal surgery

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

06

What researchers measure

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

    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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: From enrollment to the end of treatment at 1 week

07

Study locations

1 of 1 sites recruiting
  • First Hospital of China Medical University
    Shenyang, Liaoning 110000, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2023 (actual). Primary completion is estimated for Mar 2026, 28 months after the start.

Of 801 non-industry interventional studies with no phase under Colorectal Neoplasms, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 60. This study's planned 28 months is below that.

Counting every sponsor, half of 845 studies reached it within 32 months; a quarter within 14 and three quarters within 60.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 9, 2024
First posted
Oct 15, 2024
StartActual
Nov 1, 2023
Primary completionEst.
Mar 31, 2026
CompletionEst.
Mar 31, 2029
Last update
Nov 27, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06637215
Lead sponsor
First Hospital of China Medical University
Responsible party
Kai Li (Deputy Director of surgical Oncology, First Hospital of China Medical University) — Principal investigator
First posted
Oct 15, 2024
Start date
Nov 1, 2023
Primary completion
Mar 31, 2026 (estimated)
Completion
Mar 31, 2029 (estimated)
Last update
Nov 27, 2024

Study contacts

Kai Li
Contact
cmu_likai@163.com
8613998245233

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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