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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Colon Neoplasm

Intervention / Treatment
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* Procedure: Total laparoscopic with intracorporeal anastomosis by overlap method
* Procedure: Laparoscopic-assisted colectomy with extracorporeal anastomosis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Overlap group<br>Total laparoscopic with intracorporeal anastomosis by overlap method | Procedure: Total laparoscopic with intracorporeal anastomosis by overlap method<br>* 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<br>|
| Active Comparator: Traditional group<br>Laparoscopic-assisted colectomy with extracorporeal anastomosis | Procedure: Laparoscopic-assisted colectomy with extracorporeal anastomosis<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of early complications | According to Clavein Dindo grading standards（The scale is divided into four levels, with the minimum（Ⅰ） and the maximum（Ⅳ） 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anastomotic orifice stricture and torsion | According to results of intestinal barium contrast, colonoscopy and clinical symptoms to judgment | one month after surgery | 
| the time of first flatus | Observation of patients exhaust on days after operation | one month after surgery | 
| the time of first defecation | Observation of patients bowl movement on days after operation | one month after surgery | 
| the time of first oral feeding | Observation of patients oral intake on days after operation | one month after surgery | 
| postoperative hospitalization days | Observation of patients hospitalization duration on days post-surgery | one month after surgery | 
| the incision length and cosmetic | Comparing length and cosmetic of two groups measuring with metric | one month after surgery | 
| 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 |