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

Modification of Rectal Cancer Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03570684
• Other study ID #: CRCmodifiedTec01
• Status: Recruiting
• Phase: N/A
• Start date: January 5, 2018
• Est. completion date: March 2, 2019

Study information

• Verified date: June 2018
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2, 2019
• Est. primary completion date: August 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Modification of Rectal Cancer Surgery
• Rectal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	West China hospital, Sichuan University	Chengdu	Sichuan

Sponsors (2)

Lead Sponsor	Collaborator
West China Hospital	Nanchong Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the number of reloads during the surgery	the number of reloads during the surgery	during the operation
Primary	ratio of patients with 2 or more reloads	ratio of patients with 2 or more reloads	during the operation
Secondary	rate of anastomotic leaks	rate of anastomotic leaks	3 month after the surgery
Secondary	operation duration time	operation duration time	during the operation
Secondary	complication rate	the complication of the operation	3 month after the surgery