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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05034692
Other study ID # K202012-10
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 21, 2022
Est. completion date December 31, 2025

Study information

Verified date October 2022
Source Tang-Du Hospital
Contact Nan Wang, Doctor
Phone 0086-029-84778829
Email wangnandoc@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Objective:The comparison between total laparoscopic colectomy with intracorporeal anastomosis by overlap method and laparoscopic-assisted colectomy with extracorporeal anastomosis for colon cancer surgery. Condition or disease:Left colon cancer Intervention/treatment: Procedure:Intracorporeal left colectomy Overlap anastomosis Procedure: Extracorporeal left colectomy convention anastomosis


Description:

This a simple randomized, single-center, single-blind, randomized controlled trial study.The patients were randomly divided into experimental groups and control groups by computer.The perioperative recovery data, complications and oncology index of total laparoscopic colectomy with intracorporeal anastomosis and laparoscopic-assisted colectomy with extracorporeal anastomosis would be compared.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 31, 2025
Est. primary completion date December 20, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - ASA<3 classification - 18kg/m2=BMI=30kg/m2 - Neoplasm staging is T1-4a, N0-2, M0 - No previous history of abdominal surgery - No previous history of neoplasm chemoradiotherapy - No status of ileus, bowel obstruction and active hemorrhage of the digestive tract Exclusion Criteria: - Age<18 years or >75 years - ASA=3 classification - BMI<18kg/m2 or BMI>30kg/m2 - Neoplasm staging is T4b or M1 Underwent chemoradiotherapy Appeared status of ileus,bowel perforation or active hemorrhage of digestive tract Patients with pregnant

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Total laparoscopic with intracorporeal anastomosis by overlap method
After the intestinal canal was dissociated and vascularized, the intestinal canal was nuded and cut off, and the distal and proximal intestinal canals were overlapped by 6 cm
Laparoscopic-assisted colectomy with extracorporeal anastomosis
After the corresponding colon and blood vessels were dissociated and treated, the carbon dioxide pneumoperitoneum was removed. The appropriate length of the incision was cut at the corresponding position of the abdomen, and the incision protector was placed. The tumor was lifted together with the free intestinal canal to the outside of the abdomen. The intestinal canals at the quasi-dismembered sites on both sides of the tumor were nuded, and the colon-colon functional end-to-end anastomosis was performed.

Locations

Country Name City State
China General Surgery Gastrointestinal Department,Tang-Du of Fourth Military Medical University Xian Shan XI Province

Sponsors (1)

Lead Sponsor Collaborator
Tang-Du Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The incidence of early complications According to Clavein Dindo grading standards(The scale is divided into four levels, with the minimum(?) and the maximum(?) level. The higher the level that more severe symptoms.), the incidence of complications within one month after surgery, such as incision infection, bleeding, anastomotic leakage, ileus, etc., was counted one month after surgery
Secondary anastomotic orifice stricture and torsion According to results of intestinal barium contrast, colonoscopy and clinical symptoms to judgment one month after surgery
Secondary the time of first flatus Observation of patients exhaust on days after operation one month after surgery
Secondary the time of first defecation Observation of patients bowl movement on days after operation one month after surgery
Secondary the time of first oral feeding Observation of patients oral intake on days after operation one month after surgery
Secondary postoperative hospitalization days Observation of patients hospitalization duration on days post-surgery one month after surgery
Secondary the incision length and cosmetic Comparing length and cosmetic of two groups measuring with metric one month after surgery
Secondary pain score Estimate for pain of subject By Visual Analog Scale for Pain (VAS Pain,The scale is divided into four levels, with the minimum(1 score) and the maximum(10 score) level. The higher the level that more severe pain.) postoperative 6 hours, the first day and the third day
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