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Use of One Kind of Controllable Tube Ileostomy in the Low Rectal Cancer

NCT02012023 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2016-08-23

No results posted yet for this study

Summary

Most surgeons suggest the use of fecal diverting to address the high morbidity and mortality associated with anastomotic leakage (AL) in patients with high risk factors on AL who are undergoing low anterior resections(LAR). This exploratory study was conducted to evaluate the efficacy and safety of one kind of controllable tube ileostomy(CTI), which was designed to protect rectal anastomosis in patients with high risk factors on AL. Results of SCCI were compared to those of the loop ileostomy (LI) method.

In fact when we told the patients about the tube ileustomy's effect and risk, almost all the almost all of my patients like to choose tube ileustomy(I have study this method for long time and have good expeience, and my patients either choose tube ileostomy directly or let me do the choice.) So I gave all the patients who meet the requirenments all tube ileustomy and have no control group.

Conditions

  • Rectal Neoplasms
  • Low Anterior Resection

Interventions

DEVICE

Low anterior resection

DEVICE

tube ileostomy

DEVICE

loop ileostomy

DEVICE

accept reversal operation

DEVICE

remove the tube ileostomy

Sponsors & Collaborators

  • First Affiliated Hospital of Zhejiang University

    lead OTHER

Principal Investigators

  • Hua Hanju, Doctor · Zhejiang University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02012023 on ClinicalTrials.gov