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

NCT02652702 | Terminated Phase 2 DMC

• 1 other identifier: CRCCZ-D01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Carcinoma

Keywords

circular stapler-assisted colostomy

Outcome Measures

Primary Outcomes (1)

• colostomy associated complications

  measure the colostomy associated complications,such like hemorrhage,necrosis, stenosis, prolapse, and para-stomal hernia.

  2 year

Study Arms (2)

Circular Stapler-assisted Colostomy

EXPERIMENTAL

Using Circular Stapler-assisted Technique to Finish Colostomy after colorectal carcinoma surgery when patient need permanent sigmoid stoma.

Procedure: circular stapler-assisted colostomy

Hand-stitching Colostomy

EXPERIMENTAL

Using Conventional Hand-stitching Technique to Finish Colostomy after colorectal carcinoma surgery when patient need permanent sigmoid stoma.

Procedure: conventional hand-stitching colostomy

Interventions

circular stapler-assisted colostomy PROCEDURE

procedure:circular stapler-assisted colostomy device:circular stapler

Circular Stapler-assisted Colostomy

conventional hand-stitching colostomy PROCEDURE

procedure:hand-stitching colostomy

Hand-stitching Colostomy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (1)

Second Affiliated Hospital Zhejiang University College of Medicine

Hangzhou, Zhejiang, 310999, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 29, 2015
• First Posted: January 12, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: January 1, 2020
• Last Updated: July 7, 2020

Record last verified: 2020-07

Locations

CN (1)