Colonic Cancer, Rectal Cancer
Conditions
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.
Interventions
DEVICETransanal decompression tube
22 Fr transanal decompression tube
DEVICEStent
self-expandable colorectal nitinol alloys stent
Sponsors
Xuzhou Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Creation of stoma | From the date of randomization until the date of first documented creation of stoma, assessed up to 24 months | Creation of stoma include temporary and definitive stoma. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Transanal decompression tube/stent-related complications | From the date of randomization until the date of first documented transanal decompression tube/stent-related complication, assessed up to 7 days | Transanal decompression tube/stent-related complications usually include bowel perforation, migration, and stent re-obstruction. |
| Surgery-related complications | From the date of randomization until the date of first documented surgery-related complication, assessed up to 24 months | Surgery-related complications usually include wound complications and anastomotic leak. |
| Overall survival | From the date of randomization until the date of death from any cause, assessed up to 24 months | — |
Countries
China
Outcome results
None listed