Study of Intraoperative Colonic Irrigation Versus Stent Placement in Obstructive Left-Sided Colonic Cancer
| Tracking Information | |
|---|---|
| First Received Date ICMJE | September 7, 2010 |
| Last Updated Date | September 7, 2010 |
| Start Date ICMJE | Not Provided |
| Primary Completion Date | Not Provided |
| Current Primary Outcome Measures ICMJE | Not Provided |
| Original Primary Outcome Measures ICMJE | Not Provided |
| Change History | No Changes Posted |
| Current Secondary Outcome Measures ICMJE | Not Provided |
| Original Secondary Outcome Measures ICMJE | Not Provided |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Study of Intraoperative Colonic Irrigation Versus Stent Placement in Obstructive Left-Sided Colonic Cancer |
| Official Title ICMJE | Prospective, Controlled, Randomized Study of Intraoperative Colonic Irrigation vs. Stent Placement in Obstructive Left-Sided Colonic Cancer |
| Brief Summary | INTRODUCTION: There are several alternatives for one-stage emergency treatment of obstructive left-sided colonic cancer (OLCC): subtotal colectomy, intraoperative colon lavage (IOCL) with primary anastomosis, and the placement of a stent as a temporary measure prior to scheduled surgery. At present, it is not clear whether emergency perioperative lavage or the placement of a stent is the better technique. The hypothesis is that IOCL and primary anastomosis is equal safe or even safer than placement of a stent as a temporary measure prior to scheduled surgery, less length of stay and less cost. OBJECTIVE: To establish which of these two techniques is more efficient in OLCC from the point of view of morbimortality, economic cost, and long-term survival. MATERIAL AND METHODS: Prospective, controlled, randomized study of patients diagnosed with OLCC. Patients were divided into two groups: group 1: stent and deferred surgery; group 2: emergency IOCL. A simple randomization system was used. The estimated sample size required per group was 21 patients. Demographic variables, risk prediction models, postoperative morbimortality, staging, complications due to the placement of stent, surgical time, clinical follow-up, health costs and follow-up of survival were recorded. |
| Detailed Description | Not Provided |
| Study Type ICMJE | Interventional |
| Study Phase | Not Provided |
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label |
| Condition ICMJE |
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| Intervention ICMJE | Procedure: intraoperative colon lavage with primary anastomosis
Patients with obstructive left-sided colonic cancer in wich treatment in one stage procedure is intraoperative colon lavage with primary anastomosis to avoid Hartamnn´s Procedure |
| Study Arm (s) |
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| Publications * | Alcántara M, Serra-Aracil X, Falcó J, Mora L, Bombardó J, Navarro S. Prospective, controlled, randomized study of intraoperative colonic lavage versus stent placement in obstructive left-sided colonic cancer. World J Surg. 2011 Aug;35(8):1904-10. |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Terminated |
| Enrollment ICMJE | Not Provided |
| Completion Date | Not Provided |
| Primary Completion Date | Not Provided |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | Not Provided |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | Not Provided |
| Administrative Information | |
| NCT Number ICMJE | NCT01196494 |
| Other Study ID Numbers ICMJE | STENTCSPT01 |
| Has Data Monitoring Committee | No |
| Responsible Party | Not Provided |
| Study Sponsor ICMJE | Corporacion Parc Tauli |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | Corporacion Parc Tauli |
| Verification Date | January 2005 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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