ClinicalTrials.gg
Status unknownNCT03570684Updated Jun 27, 2018

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

An interventional study of Cable Tie in Modification of Rectal Cancer Surgery, sponsored by West China Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-06-27.

Sponsored by West China Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2018), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Jan 2018, registered May 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Modification of Rectal Cancer Surgery
03

In context

Lead sponsor

West China Hospital is the lead sponsor of 498 studies on the registry; 244 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

patients refuse

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • 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

  • No intervention
    non-tie group

Interventions

  • DeviceCable 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.

06

What researchers measure

Primary outcomes

  1. the number of reloads during the surgery

    the number of reloads during the surgery

    Time frame: during the operation

  2. ratio of patients with 2 or more reloads

    ratio of patients with 2 or more reloads

    Time frame: during the operation

Secondary outcomes

  1. rate of anastomotic leaks

    rate of anastomotic leaks

    Time frame: 3 month after the surgery

  2. operation duration time

    operation duration time

    Time frame: during the operation

  3. complication rate

    the complication of the operation

    Time frame: 3 month after the surgery

07

Study locations

1 of 1 sites recruiting
  • West China hospital, Sichuan University
    Chengdu, Sichuan 610000, China
    Recruiting
08

References and documents

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. PubMed 32266529 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 27, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03570684
Collaborators
Nanchong Central Hospital
Responsible party
Ziqiang Wang,MD (professor, West China Hospital) — Principal investigator
First posted
Jun 27, 2018
Start date
Jan 5, 2018
Primary completion
Aug 30, 2018 (estimated)
Completion
Mar 2, 2019 (estimated)
Last update
Jun 27, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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