Application of Overlap Method to Digestive Tract Reconstruction of Totally Laparoscopic Left Colectomy

Colon Neoplasm Clinical Trial

Official title:

Application of Overlap Method to Digestive Tract Reconstruction of Totally Laparoscopic Left Colectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05034692
• Other study ID #: K202012-10
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Colon Neoplasm
• Colonic Neoplasms

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