Study Stopped
We can not get enough sample size.
Transanal Decompression Tube Versus Stent for Acute Malignant Left-sided Colonic and Rectal Obstruction
1 other identifier
interventional
8
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 21, 2015
CompletedFirst Posted
Study publicly available on registry
October 23, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedJuly 5, 2019
July 1, 2019
8 months
October 21, 2015
July 2, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Creation of stoma
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 Outcomes (3)
Transanal decompression tube/stent-related complications
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
From the date of randomization until the date of first documented surgery-related complication, assessed up to 24 months
Overall survival
From the date of randomization until the date of death from any cause, assessed up to 24 months
Study Arms (2)
Transanal decompression tube
OTHERPatients undergo placement of the transanal decompression tube as a bridge to surgery
Stent
OTHERPatients undergo placement of the stent as a bridge to surgery
Interventions
Eligibility Criteria
You may qualify if:
- definite diagnosis of left-side colonic or rectal obstruction;
- symptomatic colonic obstruction for less than 1 week;
- colonic obstruction caused by a histologically proven malignant colonic tumor
You may not qualify if:
- suspected benign colonic or rectal obstruction;
- right-side colonic obstruction;
- patients with signs of peritonitis;
- dysfunction of blood coagulation, active bleeding, active infection, and significant cardiac or pulmonary disease;
- patients who do not want to undergo surgery.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Xuzhou Central Hospital
Xuzhou, Jiangsu, 221009, China
Related Publications (1)
Xu YS, Song T, Guo YT, Shao GQ, Du HT, Li DC, Fu YF. Placement of the Decompression Tube as a Bridge to Surgery for Acute Malignant Left-Sided Colonic Obstruction. J Gastrointest Surg. 2015 Dec;19(12):2243-8. doi: 10.1007/s11605-015-2936-7. Epub 2015 Sep 9.
PMID: 26354721BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Tao Song, MD
Xuzhou Central Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2015
First Posted
October 23, 2015
Study Start
October 1, 2015
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
July 5, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share