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| Sponsor: | Chinese University of Hong Kong |
|---|---|
| Information provided by: | Chinese University of Hong Kong |
| ClinicalTrials.gov Identifier: | NCT00164918 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer of Stomach |
Device: nasogastric tube |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Control: Active Control Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Role of Routine Nasogastric Decompression After Subtotal Gastrectomy |
| Estimated Enrollment: | 90 |
| Study Start Date: | September 2004 |
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.
Eligibility| Ages Eligible for Study: | 18 Weeks and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:All patients suffering from carcinoma of stomach, decided for operation
Exclusion Criteria:
Contacts and Locations| Contact: Enders K. W. Ng, MD | 85226322627 | endersng@surgery.cuhk.edu.hk |
| Contact: Man Yee Yung, BN | 85226322956 | myyung@surgery.cuhk.edu.hk |
| China | |
| Surgical Ward, Prince of Wales Hospital | Recruiting |
| Hong Kong, China | |
| Contact: Enders K.W. Ng, MD 85226322627 endersng@surgery.cuhk.edu.hk | |
| Contact: Man Yee Yung, BN 85226322956 myyung@surgery.cuhk.edu.hk | |
| Sub-Investigator: Chris K.W. Yau, MRCS (Ed) | |
| Principal Investigator: Enders K.W. Ng, MD | |
| Principal Investigator: | Enders K.W. Ng, MD | Chinese University of Hong Kong |
More Information
| Study ID Numbers: | CRE-2004.311 |
| Study First Received: | September 12, 2005 |
| Last Updated: | September 12, 2005 |
| ClinicalTrials.gov Identifier: | NCT00164918 History of Changes |
| Health Authority: | Hong Kong: Department of Health |
|
Neoplasms Stomach Diseases Digestive System Diseases Neoplasms by Site |
Digestive System Neoplasms Gastrointestinal Diseases Stomach Neoplasms Gastrointestinal Neoplasms |