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

Xuzhou Central Hospital8 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Colonic Cancer Rectal Cancer

Interventions

Transanal decompression tubeDEVICE

22 Fr transanal decompression tube

StentDEVICE

self-expandable colorectal nitinol alloys stent

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Xuzhou Central Hospital

Xuzhou, Jiangsu, China

Outcomes

Primary Outcomes

Creation of stoma

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 Outcomes

Transanal decompression tube/stent-related complications

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

Surgery-related complications

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

Overall survival

Time frame: From the date of randomization until the date of death from any cause, assessed up to 24 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.