Utility of Cable Tie to Decline Reloads in Laparoscopic Anterior Resection of Rectal Cancer

Not Applicable

• Conditions: Modification of Rectal Cancer Surgery
• Interventions: Device: Cable Tie

• Registration Number: NCT03570684
• Lead Sponsor: West China Hospital

Brief Summary

During the laparoscopic anterior resection of rectal cancer, transecting the mobilized rectum in the narrow pelvic was difficult and sometimes need 2-3 reloads of the endoscopic linear cutter. also the angles between the 2-3 staple line threaten the next anastomosis. this study was to explore the Cable Tie to facilitate the transection of rectum and decline the usage of the reloads.

Detailed Description

In the modern laparoscopic colorectal surgery, application of endoscopic stapler was necessary and popular, especially in rectal cancer. In the anterior resection of rectal cancer, usage of stapler increase the anal preservation. However during the laparoscopic anterior resection, transecting the mobilized rectum in the narrow pelvic was difficult, even with the flexible linear cutter. 1 reloads of the stapler was unable to transect the rectum completely, and need 2-3 reloads, especially in some fat patients, which was uneconomic.Also increased reloads increase the staple line, and 2 or 3 staple line threaten the next anastomosis, and increasing anastomotic leak rate. this study was to explore the Cable Tie to facilitate the transection of rectum and decline the usage of the reloads. During the operation, after mobilization the rectum, the disinfected Cable Tie was introduced into the pelvic cavity.then the rectum was bundled by the tie which was much easier as the tie is auto-locked. pulling the tie and the rectum would be explored clearly, and then the endoscopic linear cutter was introduced to transect the rectum. the tie made the rectum folded not applanate, that the cutter was able to transect the rectum easily and with less reloader.

Study Timeline

• Study Start: 2018-01-05
• Study First Submitted: 2018-05-05
• Status Verified: 2018-06
• Study First Submitted QC: 2018-06-16
• Last Update Submitted: 2018-06-16
• Study First Posted: 2018-06-27
• Last Update Posted: 2018-06-27
• Primary Completion: 2018-08-30
• Study Completion: 2019-03-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. rectal cancer patients;
2. the tumor located 5-12cm from the anal verge, that an anterior resection was needed.
3. the cancer has no organ invasion.

Exclusion Criteria

patients refuse

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
tie group	Cable Tie	During the operation, after mobilization the rectum, the disinfected Cable Tie was introduced into the pelvic cavity.then the rectum was bundled by the tie which was much easier as the tie is auto-locked. pulling the tie and the rectum would be explored clearly, and then the endoscopic linear cutter was introduced to transect the rectum.

Primary Outcome Measures

Name	Time	Method
the number of reloads during the surgery	during the operation	the number of reloads during the surgery
ratio of patients with 2 or more reloads	during the operation	ratio of patients with 2 or more reloads

Secondary Outcome Measures

Name	Time	Method
operation duration time	during the operation	operation duration time
rate of anastomotic leaks	3 month after the surgery	rate of anastomotic leaks
complication rate	3 month after the surgery	the complication of the operation

Trial Locations

Locations (1)

West China hospital, Sichuan University; 🇨🇳 Chengdu, Sichuan, China