Role of Routine Nasogastric Decompression After Subtotal Gastrectomy
Primary Purpose
Cancer of Stomach
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
nasogastric tube
Sponsored by
About this trial
This is an interventional treatment trial for Cancer of Stomach
Eligibility Criteria
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
Sites / Locations
- Surgical Ward, Prince of Wales HospitalRecruiting
Outcomes
Primary Outcome Measures
Bowel function and related symptoms early post-op
Secondary Outcome Measures
Full Information
NCT ID
NCT00164918
First Posted
September 12, 2005
Last Updated
September 12, 2005
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT00164918
Brief Title
Role of Routine Nasogastric Decompression After Subtotal Gastrectomy
Official Title
Role of Routine Nasogastric Decompression After Subtotal Gastrectomy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Unknown status
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Stomach
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
nasogastric tube
Primary Outcome Measure Information:
Title
Bowel function and related symptoms early post-op
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Enders K. W. Ng, MD
Phone
85226322627
Email
endersng@surgery.cuhk.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Man Yee Yung, BN
Phone
85226322956
Email
myyung@surgery.cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enders K.W. Ng, MD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Surgical Ward, Prince of Wales Hospital
City
Hong Kong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Enders K.W. Ng, MD
Phone
85226322627
Email
endersng@surgery.cuhk.edu.hk
First Name & Middle Initial & Last Name & Degree
Man Yee Yung, BN
Phone
85226322956
Email
myyung@surgery.cuhk.edu.hk
First Name & Middle Initial & Last Name & Degree
Chris K.W. Yau, MRCS (Ed)
First Name & Middle Initial & Last Name & Degree
Enders K.W. Ng, MD
12. IPD Sharing Statement
Learn more about this trial
Role of Routine Nasogastric Decompression After Subtotal Gastrectomy
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