- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00164918
Role of Routine Nasogastric Decompression After Subtotal Gastrectomy
September 12, 2005 updated by: Chinese University of Hong Kong
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.
Study Overview
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.
Study Type
Interventional
Enrollment
90
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hong Kong, China
- Recruiting
- Surgical Ward, Prince of Wales Hospital
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Contact:
- Man Yee Yung, BN
- Phone Number: 85226322956
- Email: myyung@surgery.cuhk.edu.hk
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Contact:
- Enders K.W. Ng, MD
- Phone Number: 85226322627
- Email: endersng@surgery.cuhk.edu.hk
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Sub-Investigator:
- Chris K.W. Yau, MRCS (Ed)
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Principal Investigator:
- Enders K.W. Ng, MD
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 months and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:All patients suffering from carcinoma of stomach, decided for operation
- subtotal, D1/D2 dissection
- palliative resection
Exclusion Criteria:
- actively bleeding tumor
- perforation of tumor
- patient present with gastric outlet obstruction
- combine organ excision
- known diabetes with nephropathy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Bowel function and related symptoms early post-op
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Enders K.W. Ng, MD, Chinese University of Hong Kong
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2004
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 14, 2005
Study Record Updates
Last Update Posted (Estimate)
September 14, 2005
Last Update Submitted That Met QC Criteria
September 12, 2005
Last Verified
September 1, 2005
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRE-2004.311
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.