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

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

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.

Study Overview

• Status: Unknown
• Conditions: Modification of Rectal Cancer Surgery
• Intervention / Treatment: Device: Cable Tie

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610000
      • Recruiting
      • West China Hospital, Sichuan University
      • Contact: Ziqiang Wang, PhD,MD; Phone Number: +8618980602028; Email: wzqtrial@gmail.com
      • Contact: Xiangbing Deng, MD; Phone Number: +8613730677124; Email: 247940362@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: tie group; 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; 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.
No Intervention: non-tie group

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: West China Hospital
• Collaborators: Nanchong Central Hospital

Publications and helpful links

General Publications

• Bi L, Deng X, Meng X, Yang X, Wei M, Wu Q, Ren M, Wang Z. Ligating the rectum with cable tie facilitates rectum transection in laparoscopic anterior resection of rectal cancer. Langenbecks Arch Surg. 2020 Mar;405(2):233-239. doi: 10.1007/s00423-020-01863-6. Epub 2020 Apr 8.

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2018
• Primary Completion (Anticipated): August 30, 2018
• Study Completion (Anticipated): March 2, 2019

Study Registration Dates

• First Submitted: May 5, 2018
• First Submitted That Met QC Criteria: June 16, 2018
• First Posted (Actual): June 27, 2018

Study Record Updates

• Last Update Posted (Actual): June 27, 2018
• Last Update Submitted That Met QC Criteria: June 16, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: CRCmodifiedTec01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No