Utility of Cable Tie to Decline Reloads in Laparoscopic Anterior Resection of Rectal Cancer
Primary Purpose
Modification of Rectal Cancer Surgery
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Cable Tie
Sponsored by
About this trial
This is an interventional treatment trial for Modification of Rectal Cancer Surgery
Eligibility Criteria
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
Sites / Locations
- West China hospital, Sichuan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
tie group
non-tie group
Arm Description
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.
Outcomes
Primary Outcome Measures
the number of reloads during the surgery
the number of reloads during the surgery
ratio of patients with 2 or more reloads
ratio of patients with 2 or more reloads
Secondary Outcome Measures
rate of anastomotic leaks
rate of anastomotic leaks
operation duration time
operation duration time
complication rate
the complication of the operation
Full Information
NCT ID
NCT03570684
First Posted
May 5, 2018
Last Updated
June 16, 2018
Sponsor
West China Hospital
Collaborators
Nanchong Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03570684
Brief Title
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
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 5, 2018 (Actual)
Primary Completion Date
August 30, 2018 (Anticipated)
Study Completion Date
March 2, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West China Hospital
Collaborators
Nanchong Central Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Modification of Rectal Cancer Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
comparing the recent tie used patients with the previous respective data.
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
tie group
Arm Type
Experimental
Arm Description
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.
Arm Title
non-tie group
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Cable Tie
Intervention Description
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.
Primary Outcome Measure Information:
Title
the number of reloads during the surgery
Description
the number of reloads during the surgery
Time Frame
during the operation
Title
ratio of patients with 2 or more reloads
Description
ratio of patients with 2 or more reloads
Time Frame
during the operation
Secondary Outcome Measure Information:
Title
rate of anastomotic leaks
Description
rate of anastomotic leaks
Time Frame
3 month after the surgery
Title
operation duration time
Description
operation duration time
Time Frame
during the operation
Title
complication rate
Description
the complication of the operation
Time Frame
3 month after the surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
West China hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ziqiang Wang, PhD,MD
Phone
+8618980602028
Email
wzqtrial@gmail.com
First Name & Middle Initial & Last Name & Degree
Xiangbing Deng, MD
Phone
+8613730677124
Email
247940362@qq.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
32266529
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.
Results Reference
derived
Learn more about this trial
Utility of Cable Tie to Decline Reloads in Laparoscopic Anterior Resection of Rectal Cancer
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