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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Colonic Cancer, Rectal Cancer

Intervention / Treatment
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* Device: Transanal decompression tube
* Device: Stent


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transanal decompression tube/stent-related complications | 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 | 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 |  | From the date of randomization until the date of death from any cause, assessed up to 24 months |