Clinical trial NCT03570684: Utility of Cable Tie to Decline Reloads in Laparoscopic Anterior Resection of Rectal Cancer
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Modification of Rectal Cancer Surgery
Lead sponsor: West China Hospital
Sponsor class: OTHER
Collaborators: name: Nanchong Central Hospital
First posted: 2018-06-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: comparing the recent tie used patients with the previous respective data.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: the number of reloads during the surgery
timeFrame: during the operation
measure: ratio of patients with 2 or more reloads
timeFrame: during the operation
Secondary outcomes:
measure: rate of anastomotic leaks
timeFrame: 3 month after the surgery
measure: operation duration time
timeFrame: during the operation
measure: complication rate
timeFrame: 3 month after the surgery
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China hospital, Sichuan University
state: Sichuan
Study officials:
References:
citation: 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.