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Study Comparing Circular Stapler-assisted Colostomy vs Hand-stitching Colostomy of Colorectal Cancer Patients (STAPLER)

Zhejiang University logo

Zhejiang University

Status and phase

Terminated
Phase 2

Conditions

Colorectal Carcinoma

Treatments

Procedure: conventional hand-stitching colostomy
Procedure: circular stapler-assisted colostomy

Study type

Interventional

Funder types

Other

Identifiers

NCT02652702
CRCCZ-D01

Details and patient eligibility

About

Conventional hand-stitching colostomy involves extensive hand-stitching by the surgeon. There are significant variations in the outcome of surgery due to differences in the suture techniques of surgeons. The use of a circular stapler in colostomy seems more rapid and efficient colostomy than the conventional methods.But all those reports are single center retrospective cohort study,no randomized controlled trials have been carried out so far.The aim of this study is to comparing the safety and efficiency of circular stapler-assisted colostomy with conventional hand-stitching colostomy in patients with colorectal carcinoma.

Full description

It has been difficult to standardize the pull-out of the colon and the size, shape and sutures of the colostomy due to the different techniques employed and varying levels of skill of surgeons in different regions.Thus, various postoperative colostomy complications are inevitable after surgery. Surgeons have been looking for a simple and efficient way to standardize colostomy and reduce its complications.

So we want to compare the safety and efficiency of circular stapler-assisted colostomy with conventional hand-stitching colostomy in colorectal cancer patients.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Receiving permanent colostomy because of colorectal cancer
  • Age of ≥18 and ≤80

Exclusion criteria

  • Not willing or incapable to comply with all study visits and assessments
  • Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that puts the patient at high risk for treatment-related complications

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Circular Stapler-assisted Colostomy
Experimental group
Description:
Using Circular Stapler-assisted Technique to Finish Colostomy after colorectal carcinoma surgery when patient need permanent sigmoid stoma.
Treatment:
Procedure: circular stapler-assisted colostomy
Hand-stitching Colostomy
Experimental group
Description:
Using Conventional Hand-stitching Technique to Finish Colostomy after colorectal carcinoma surgery when patient need permanent sigmoid stoma.
Treatment:
Procedure: conventional hand-stitching colostomy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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