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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-01

Study Completion Date

2016-06-01

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.

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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.

Conditions

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Colonic Cancer Rectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Transanal decompression tube

Patients undergo placement of the transanal decompression tube as a bridge to surgery

Group Type OTHER

Transanal decompression tube

Intervention Type DEVICE

22 Fr transanal decompression tube

Stent

Patients undergo placement of the stent as a bridge to surgery

Group Type OTHER

Stent

Intervention Type DEVICE

self-expandable colorectal nitinol alloys stent

Interventions

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Transanal decompression tube

22 Fr transanal decompression tube

Intervention Type DEVICE

Stent

self-expandable colorectal nitinol alloys stent

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No