Is Nasogastric Tube Necessary After Pancreaticoduodenectomy?
1 other identifier
interventional
90
1 country
1
Brief Summary
Nasogastric decompression was routinely used in most major intra-abdominal operations. Nasogastric tube intubation was thought to decrease postoperative ileus (nausea, vomiting, and gastric distension). Wound and respiratory complications, and to reduce the incidence of anastomotic leaks after gastrointestinal surgery. However, the necessity of nasogastric decompression following elective abdominal surgery has been increasingly questioned over the last several years. Many clinical studies have suggested that this practice does not provide any benefit but could increase patient discomfort and respiratory complications. Furthermore, meta-analyses have concluded that routine nasogastric decompression is no longer warranted after elective abdominal surgery. Elective abdominal surgery without nasogastric decompression was initially tested and then widely used on patients with colorectal surgery. However, after upper gastrointestinal operations such as gastrectomy, nasogastric has been considered necessary to prevent the consequences of postoperative ileus (anastomotic leakage or leaking from the duodenal stump. Therefore, studies of gastrectomy without nasogastric tube emerged later than those of colectomy . In spite more and more studies reported of no need of nasogastric tube after abdominal operation, no papers reported after pancreaticoduodenectomy. Postulated causes of lack in studies to assess the need of a nasogastric tube after pancreaticoduodenectomy include anticipated prolonged postoperative paralytic ileus caused by PD-related extensive destruction and potential risk of gastric stasis after PD. However, our pilot study of retrospective analysis of postoperative NG drainage amount in 100 patients recently having PD at our hospital showed more than 90 % of patients had less than 200cc/day NG drainage amount in the first three days after operation. Theoretically, these patients will not need a nasogastric tube after pancreaticoduodenectomy. Therefore, we propose a prospective multicenter randomized trial to assess the need of a nasogastric tube after PD. Elective abdominal surgery without nasogastric decompression was initially tested and then widely used on patients with colorectal surgery.7-10 However, after upper gastrointestinal operations such as gastrectomy, nasogastric has been considered necessary to prevent the consequences of postoperative ileus (anastomotic leakage or leaking from the duodenal stump. Therefore, studies of gastrectomy without nasogastric tube emerged later than those of colectomy .11-13 In spite more and more studies reported of no need of nasogastric tube after abdominal operation, no papers reported after pancreaticoduodenectomy. Postulated causes of lack in studies to assess the need of a nasogastric tube after pancreaticoduodenectomy include anticipated prolonged postoperative paralytic ileus caused by PD-related extensive destruction and potential risk of gastric stasis after PD. However, our pilot study of retrospective analysis of postoperative NG drainage amount in 100 patients recently having PD at our hospital showed more than 90 % of patients had less than 200cc/day NG drainage amount in the first three days after operation. Theoretically, these patients will not need a nasogastric tube after pancreaticoduodenectomy. Therefore, we propose a prospective multicenter randomized trial to assess the need of a nasogastric tube after PD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 27, 2013
CompletedFirst Posted
Study publicly available on registry
October 21, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedOctober 23, 2013
October 1, 2013
3 years
September 27, 2013
October 21, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Complication rate
To compare the control and modified groups, all surgical complications will be further classified by severity using a novel grading system proposed by Dindo et al. In brief, grade I and II complications include only minor deteriorations from the normal postoperative course that can be treated with drugs, blood transfusion, physiotherapy, and nutritional supply. Grade III complications require interventional treatment. Grade IV complications are life-threatening and require intensive care unit management. Death is the only grade V complication. Grade I and II complications will be classified as minor and grades III, IV, and V will be classified as major.
one month
Study Arms (2)
No nasogastric tube insertion before pancreaticoduodenectomy
EXPERIMENTALThe patients receiving pancreaticoduodenectomy will not undergo NG tube insertion before operation
Pre-operative NG tube use
ACTIVE COMPARATORThe patients receiving pancreaticoduodenectomy will undergo NG tube insertion before operation
Interventions
Eligibility Criteria
You may qualify if:
- Patients receiving pancreaticoduodenectomy
You may not qualify if:
- Peritonitis history
- Previous abdominal operation
- pregnancy
- Gastroesophageal reflux disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National taiwan University Hospital
Taipei, 100, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yu-Wen Tien, Ph.D.
National Taiwan University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2013
First Posted
October 21, 2013
Study Start
September 1, 2013
Primary Completion
September 1, 2016
Study Completion
November 1, 2016
Last Updated
October 23, 2013
Record last verified: 2013-10