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TerminatedNCT02585271Updated Jul 5, 2019

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

An interventional study of Transanal decompression tube and Stent in Colonic Cancer and Rectal Cancer, sponsored by Xuzhou Central Hospital. Terminated at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-07-05.

Sponsored by Xuzhou Central Hospital · Not applicable, Interventional, and Treatment

Why this study was terminated
We can not get enough sample size.
Phase
Not applicable
Study type
Interventional
Enrollment
8
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Colonic Cancer
  • Rectal Cancer
03

In context

Colonic Neoplasms

1,485 studies on the registry are indexed under Colonic Neoplasms; 362 are open to participants now.

This study's enrollment of 8 is below the median of 89 across 1,067 interventional studies indexed under Colonic Neoplasms.

Browse Colonic Neoplasms studies →

Lead sponsor

Xuzhou Central Hospital is the lead sponsor of 21 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • Other
    Transanal decompression tube

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

    Device: Transanal decompression tube

  • Other
    Stent

    Patients undergo placement of the stent as a bridge to surgery

    Device: Stent

Interventions

  • DeviceTransanal decompression tube

    22 Fr transanal decompression tube

  • DeviceStent

    self-expandable colorectal nitinol alloys stent

06

What researchers measure

Primary outcomes

  1. Creation of stoma

    Creation of stoma include temporary and definitive stoma.

    Time frame: From the date of randomization until the date of first documented creation of stoma, assessed up to 24 months

Secondary outcomes

  1. Transanal decompression tube/stent-related complications

    Transanal decompression tube/stent-related complications usually include bowel perforation, migration, and stent re-obstruction.

    Time frame: From the date of randomization until the date of first documented transanal decompression tube/stent-related complication, assessed up to 7 days

  2. Surgery-related complications

    Surgery-related complications usually include wound complications and anastomotic leak.

    Time frame: From the date of randomization until the date of first documented surgery-related complication, assessed up to 24 months

  3. Overall survival

    Time frame: From the date of randomization until the date of death from any cause, assessed up to 24 months

07

Study locations

1 site
  • Xuzhou Central Hospital
    Xuzhou, Jiangsu 221009, China
08

References and documents

Publications

  • 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. PubMed 26354721 ↗

Individual participant data

Plan to share: No

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2015 to primary completion in Jun 2016, 8 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 21, 2015
First posted
Oct 23, 2015
StartActual
Oct 1, 2015
Primary completionActual
Jun 1, 2016
CompletionActual
Jun 1, 2016
Last update
Jul 5, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02585271
Lead sponsor
Xuzhou Central Hospital
Responsible party
Sponsor
First posted
Oct 23, 2015
Start date
Oct 1, 2015
Primary completion
Jun 1, 2016
Completion
Jun 1, 2016
Last update
Jul 5, 2019

Study contacts

Tao Song, MD
study director · Xuzhou Central Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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