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

NCT ID: NCT06637215

Last Updated: 2024-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

352 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2029-03-31

Brief Summary

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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。

Detailed Description

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Conditions

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Colorectal Carcinoma Day Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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laparoscopic colorectal day surgery

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

Group Type EXPERIMENTAL

laparoscopic colorectal day surgery

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

traditional laparoscopic colorectal surgery

Intervention Type PROCEDURE

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

Interventions

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laparoscopic colorectal day surgery

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

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Hospital of China Medical University

OTHER

Sponsor Role lead

Responsible Party

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Kai Li

Deputy Director of surgical Oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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First Hospital of China Medical University

Shenyang, Liaoning, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Kai Li

Role: CONTACT

8613998245233

Facility Contacts

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Kai Li, MD

Role: primary

8613998245233

Other Identifiers

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FirstHCMU_ambulatory_surgery

Identifier Type: -

Identifier Source: org_study_id