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

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02585271
• Other study ID #: 46650455-0
• Status: Terminated
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Colonic Cancer
• Colonic Neoplasms
• Rectal Cancer

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