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

Not Applicable

Terminated

• Conditions: Rectal Cancer; Colonic Cancer
• Interventions: Device: Stent; Device: Transanal decompression tube

• Registration Number: NCT02585271
• Lead Sponsor: Xuzhou Central Hospital

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.

Study Timeline

• Study Start: 2015-10-01
• Study First Submitted: 2015-10-21
• Study First Submitted QC: 2015-10-22
• Study First Posted: 2015-10-23
• Primary Completion: 2016-06-01
• Study Completion: 2016-06-01
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-02
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stent	Stent	Patients undergo placement of the stent as a bridge to surgery
Transanal decompression tube	Transanal decompression tube	Patients undergo placement of the transanal decompression tube as a bridge to surgery

Primary Outcome Measures

Name	Time	Method
Creation of stoma	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.

Secondary Outcome Measures

Name	Time	Method
Surgery-related complications	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.
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	Transanal decompression tube/stent-related complications usually include bowel perforation, migration, and stent re-obstruction.
Overall survival	From the date of randomization until the date of death from any cause, assessed up to 24 months

Trial Locations

Locations (1)

Xuzhou Central Hospital; 🇨🇳 Xuzhou, Jiangsu, China