Health TrialsbyHealthPanel

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

ConditionsColorectal CarcinomaDay Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFirst Hospital of China Medical University

About this trial

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。

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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；

Disqualifiers

Elderly patients with multiple basic diseases；

Moderate to severe anemia；

Severe hypoproteinemia；

Diabetes that is not well controlled；

Trial design

Design model

Parallel

Treatments tested in this trial

  • laparoscopic colorectal day surgery

    Procedure/Surgery

    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/Surgery

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

Treatment groups

352 Participants
are divided into 2 treatment groups
Group A: laparoscopic colorectal day surgeryExperimental treatment 1 intervention
Group B: traditional laparoscopic colorectal surgeryActive comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

First Hospital of China Medical University

Lead sponsor

Source ClinicalTrials.gov
Apply now