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Is Nasogastric Tube Necessary After Pancreaticoduodenectomy?

NCT01991392 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2013-11-26

No results posted yet for this study

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). Would 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 within postoperative day three. Theoretically, these patients might not need a nasogastric tube after pancreaticoduodenectomy. Therefore, investigators propose a prospective multicenter randomized trial to assess the need of a nasogastric tube after PD.

Conditions

Interventions

DEVICE

Nasogastric tube

For nasogastric decompression.

DEVICE

No nasogastric tube

For nasogastric decompression.

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Yu-Wen Tien, Ph.D · Natinal Taiwan University Hospital

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2016-10-31
Completion
2016-11-30

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01991392 on ClinicalTrials.gov