Transanal Decompression Tube Versus Stent for Acute Malignant Left-sided Colonic and Rectal Obstruction
Primary Purpose
Colonic Cancer, Rectal Cancer
Status
Terminated
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Transanal decompression tube
Stent
Sponsored by
About this trial
This is an interventional treatment trial for Colonic Cancer
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- Xuzhou Central Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Transanal decompression tube
Stent
Arm Description
Patients undergo placement of the transanal decompression tube as a bridge to surgery
Patients undergo placement of the stent as a bridge to surgery
Outcomes
Primary Outcome Measures
Creation of stoma
Creation of stoma include temporary and definitive stoma.
Secondary Outcome Measures
Transanal decompression tube/stent-related complications
Transanal decompression tube/stent-related complications usually include bowel perforation, migration, and stent re-obstruction.
Surgery-related complications
Surgery-related complications usually include wound complications and anastomotic leak.
Overall survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02585271
Brief Title
Transanal Decompression Tube Versus Stent for Acute Malignant Left-sided Colonic and Rectal Obstruction
Official Title
Transanal Decompression Tube Versus Stent as a Bridge to Surgery for Acute Malignant Left-sided Colonic and Rectal Obstruction
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Terminated
Why Stopped
We can not get enough sample size.
Study Start Date
October 1, 2015 (Actual)
Primary Completion Date
June 1, 2016 (Actual)
Study Completion Date
June 1, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xuzhou Central Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Cancer, Rectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transanal decompression tube
Arm Type
Other
Arm Description
Patients undergo placement of the transanal decompression tube as a bridge to surgery
Arm Title
Stent
Arm Type
Other
Arm Description
Patients undergo placement of the stent as a bridge to surgery
Intervention Type
Device
Intervention Name(s)
Transanal decompression tube
Intervention Description
22 Fr transanal decompression tube
Intervention Type
Device
Intervention Name(s)
Stent
Intervention Description
self-expandable colorectal nitinol alloys stent
Primary Outcome Measure Information:
Title
Creation of stoma
Description
Creation of stoma include temporary and definitive stoma.
Time Frame
From the date of randomization until the date of first documented creation of stoma, assessed up to 24 months
Secondary Outcome Measure Information:
Title
Transanal decompression tube/stent-related complications
Description
Transanal decompression tube/stent-related complications usually include bowel perforation, migration, and stent re-obstruction.
Time Frame
From the date of randomization until the date of first documented transanal decompression tube/stent-related complication, assessed up to 7 days
Title
Surgery-related complications
Description
Surgery-related complications usually include wound complications and anastomotic leak.
Time Frame
From the date of randomization until the date of first documented surgery-related complication, assessed up to 24 months
Title
Overall survival
Time Frame
From the date of randomization until the date of death from any cause, assessed up to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tao Song, MD
Organizational Affiliation
Xuzhou Central Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Xuzhou Central Hospital
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221009
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26354721
Citation
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.
Results Reference
background
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Transanal Decompression Tube Versus Stent for Acute Malignant Left-sided Colonic and Rectal Obstruction
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