Clinical trial NCT02585271: Transanal Decompression Tube Versus Stent for Acute Malignant Left-sided Colonic and Rectal Obstruction
Official title: Transanal Decompression Tube Versus Stent as a Bridge to Surgery for Acute Malignant Left-sided Colonic and Rectal Obstruction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Colonic Cancer
Rectal Cancer
Lead sponsor: Xuzhou Central Hospital
Sponsor class: OTHER
First posted: 2015-10-23
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Creation of stoma
timeFrame: From the date of randomization until the date of first documented creation of stoma, assessed up to 24 months
Secondary outcomes:
measure: Transanal decompression tube/stent-related complications
timeFrame: From the date of randomization until the date of first documented transanal decompression tube/stent-related complication, assessed up to 7 days
measure: Surgery-related complications
timeFrame: From the date of randomization until the date of first documented surgery-related complication, assessed up to 24 months
measure: Overall survival
timeFrame: From the date of randomization until the date of death from any cause, assessed up to 24 months
Other outcomes:
Locations:
city: Xuzhou
country: China
facility: Xuzhou Central Hospital
state: Jiangsu
Study officials:
affiliation: Xuzhou Central Hospital
name: Tao Song, MD
role: STUDY_DIRECTOR
References:
citation: 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.