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| Tracking Information | |||||||||
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| First Received Date ICMJE | September 12, 2005 | ||||||||
| Last Updated Date | September 12, 2005 | ||||||||
| Start Date ICMJE | September 2004 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE |
Bowel function and related symptoms early post-op | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Role of Routine Nasogastric Decompression After Subtotal Gastrectomy | ||||||||
| Official Title ICMJE | Role of Routine Nasogastric Decompression After Subtotal Gastrectomy | ||||||||
| Brief Summary | The aim of the study is to evaluate whether subtotal gastrectomy without post-operative nasogastric decompression is better in terms of early post-operative bowel function and chest complication. |
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| Detailed Description | Nasogastric decompression is an intra-operative routine in most of the time to facilitate exposure of operative field during elective subtotal gastrectomy, but whether it should be retained post-operatively is controversial. Nasogastric decompression helps to drain the gastric remnant in case there is edema around the gastrojejunostomy, ileus and delayed gastric emptying, which can theoretically relieve nausea and abdominal distension. Besides, it may help decrease diaphragmatic splintage and hence decrease chance of chest infection if ileus occurs. However, nasogastric intubation could cause patient discomfort; also it has been shown that it would cause gastroesophageal reflux which may be associated with chest complication. There have been studies showing that routine post-operative nasogastric decompression is not necessary for gastrectomy in general, but the role in subtotal gastrectomy for stomach cancer is not well defined. |
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| Study Phase | Phase III | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study | ||||||||
| Condition ICMJE | Cancer of Stomach | ||||||||
| Intervention ICMJE | Device: nasogastric tube | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Enrollment ICMJE | 90 | ||||||||
| Completion Date | |||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:All patients suffering from carcinoma of stomach, decided for operation
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Weeks and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | China | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00164918 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | CRE-2004.311 | ||||||||
| Study Sponsor ICMJE | Chinese University of Hong Kong | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | Chinese University of Hong Kong | ||||||||
| Verification Date | September 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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