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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Utility of Cable Tie in Laparoscopic Anterior Resection of Rectal Cancer to Decline Reloads of Endoscopic Linear Cutter During the Transection of Rectum

Conditions
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Modification of Rectal Cancer Surgery

Intervention / Treatment
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* Device: Cable Tie


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: rectal cancer patients; the tumor located 5-12cm from the anal verge, that an anterior resection was needed. the cancer has no organ invasion. Exclusion Criteria: patients refuse

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: comparing the recent tie used patients with the previous respective data.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tie group<br>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. | Device: Cable Tie<br>* 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 easy 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. when the rectum was resected completely, the tie was get out with the specimen, and do not live in the abdomen.<br>|
| No Intervention: non-tie group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of reloads during the surgery | the number of reloads during the surgery | during the operation | 
| ratio of patients with 2 or more reloads | ratio of patients with 2 or more reloads | during the operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of anastomotic leaks | rate of anastomotic leaks | 3 month after the surgery | 
| operation duration time | operation duration time | during the operation | 
| complication rate | the complication of the operation | 3 month after the surgery |