Transanal Decompression Tube Versus Stent for Acute Malignant Left-sided Colonic and Rectal Obstruction

July 2, 2019 updated by: Xuzhou Central Hospital

Transanal Decompression Tube Versus Stent as a Bridge to Surgery for Acute Malignant Left-sided Colonic and Rectal Obstruction

The purpose of this study is to compare the clinical outcomes of transanal decompression tube as a bridge to surgery with stent as a bridge to surgery for acute malignant left-sided colonic and rectal obstruction.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Approximately 8-47 % of patients with colorectal cancer will present with colonic obstruction. Left-sided colonic and rectal cancer is responsible for nearly 70% of acute colonic obstruction. Emergency colonic surgery for acute obstruction is associated with a higher mortality and morbidity rate than elective surgery. Preoperative decompression results in a less dilated bowel that is more amenable to an elective surgery. Both transanal decompression tube and stent can serve a good preoperative decompression effect and serve a good bridge to surgery. Investigators aim to compare the clinical outcomes of transanal decompression tube as a bridge to surgery with stent as a bridge to surgery for acute malignant left-sided colonic and rectal obstruction.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Xuzhou, Jiangsu, China, 221009
        • Xuzhou Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. definite diagnosis of left-side colonic or rectal obstruction;
  2. symptomatic colonic obstruction for less than 1 week;
  3. colonic obstruction caused by a histologically proven malignant colonic tumor

Exclusion Criteria:

  1. suspected benign colonic or rectal obstruction;
  2. right-side colonic obstruction;
  3. patients with signs of peritonitis;
  4. dysfunction of blood coagulation, active bleeding, active infection, and significant cardiac or pulmonary disease;
  5. patients who do not want to undergo surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Transanal decompression tube
Patients undergo placement of the transanal decompression tube as a bridge to surgery
Device: Transanal decompression tube
22 Fr transanal decompression tube
Other: Stent
Patients undergo placement of the stent as a bridge to surgery
Device: Stent
self-expandable colorectal nitinol alloys stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Creation of stoma
Time Frame: From the date of randomization until the date of first documented creation of stoma, assessed up to 24 months
Creation of stoma include temporary and definitive stoma.
From the date of randomization until the date of first documented creation of stoma, assessed up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transanal decompression tube/stent-related complications
Time Frame: From the date of randomization until the date of first documented transanal decompression tube/stent-related complication, assessed up to 7 days
Transanal decompression tube/stent-related complications usually include bowel perforation, migration, and stent re-obstruction.
From the date of randomization until the date of first documented transanal decompression tube/stent-related complication, assessed up to 7 days
Surgery-related complications
Time Frame: From the date of randomization until the date of first documented surgery-related complication, assessed up to 24 months
Surgery-related complications usually include wound complications and anastomotic leak.
From the date of randomization until the date of first documented surgery-related complication, assessed up to 24 months
Overall survival
Time Frame: From the date of randomization until the date of death from any cause, assessed up to 24 months
From the date of randomization until the date of death from any cause, assessed up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xuzhou Central Hospital

Investigators

  • Study Director: Tao Song, MD, Xuzhou Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

October 21, 2015

First Submitted That Met QC Criteria

October 22, 2015

First Posted (Estimate)

October 23, 2015

Study Record Updates

Last Update Posted (Actual)

July 5, 2019

Last Update Submitted That Met QC Criteria

July 2, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 46650455-0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rectal Cancer

Clinical Trials on Transanal decompression tube

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Korea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe