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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02585271
Other study ID # 46650455-0
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date October 1, 2015
Est. completion date June 1, 2016

Study information

Verified date July 2019
Source Xuzhou Central Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 8
Est. completion date June 1, 2016
Est. primary completion date June 1, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Device:
Transanal decompression tube
22 Fr transanal decompression tube
Stent
self-expandable colorectal nitinol alloys stent

Locations

Country Name City State
China Xuzhou Central Hospital Xuzhou Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
Xuzhou Central Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary Overall survival From the date of randomization until the date of death from any cause, assessed up to 24 months
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