Is Nasogastric Tube Necessary After Pancreaticoduodenectomy?
NCT01966406 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90
Last updated 2013-10-23
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.
Conditions
Interventions
- DEVICE
-
Nasogastric tube
- OTHER
-
No nasogastric tube
Sponsors & Collaborators
-
National Taiwan University Hospital
lead OTHER
Principal Investigators
-
Yu-Wen Tien, Ph.D. · National Taiwan University Hospital
Study Design
- Allocation
- RANDOMIZED
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-09-30
- Primary Completion
- 2016-09-30
- Completion
- 2016-11-30
Countries
- Taiwan
Study Locations
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