Role of Routine Nasogastric Decompression After Subtotal Gastrectomy

Cancer of Stomach Clinical Trial

Official title:

Role of Routine Nasogastric Decompression After Subtotal Gastrectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00164918
• Other study ID #: CRE-2004.311
• Status: Recruiting
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: September 12, 2005
• Start date: September 2004

Study information

• Verified date: September 2005
• Source: Chinese University of Hong Kong
• Contact: Enders K. W. Ng, MD
• Phone: 85226322627
• Email: endersng[@]surgery.cuhk.edu.hk
• Is FDA regulated: No
• Health authority: Hong Kong: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Weeks and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer of Stomach
• Stomach Neoplasms

Intervention

Device:
• nasogastric tube

Locations

Country	Name	City	State
China	Surgical Ward, Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bowel function and related symptoms early post-op