Nasogastric Tube in Pancreatic Surgery

Not Applicable

• Conditions: Pancreatic Surgery; Nasogastric Tube Decompression
• Interventions: Procedure: non-NGT group; Procedure: NGT group

• Registration Number: NCT03462602
• Lead Sponsor: Tongji Hospital

Brief Summary

Introduction: The value of routine nasogastric tube (NGT) decompression after pancreatic surgeries is not yet established. Previous studies in the setting of abdominal surgery suggested that the use of NGT does not accomplish any of its intended goals.

Methods/design: This is a prospective, randomized, controlled multicenter trial with two treatment arms. One group underwent pancreatic surgeries with routine NGT and was left in place after surgery until the patient passed flatus or stool. The other group underwent pancreatic surgeries without receiving NGT decompression, in which the NGT was removed at the end of surgery.

Discussion: Routine NGT decompression after pancreatic surgeries does or does not appear to have its anticipated advantages would be discovered in this RCT.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-26
• Status Verified: 2018-03
• Study First Submitted QC: 2018-03-05
• Last Update Submitted: 2018-03-05
• Study First Posted: 2018-03-12
• Last Update Posted: 2018-03-12
• Study Start: 2018-05-01
• Primary Completion: 2020-05-01
• Study Completion: 2021-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients with age between 18 - 80 years.
• Patients underwent any kind of pancreatic surgeries, including but not limited to PD, distal pancreatectomy, central pancreatectomy, pancreatic enucleation, etc.
• Patients accepted the trial and could completed a written consent.

Exclusion Criteria

• Combined with digestive tract obstruction before the surgery.
• History of upper abdominal surgery.
• Serious heart, brain, lung, metabolic diseases history.
• Pregnant women.
• Unwillingness or inability to consent for the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
non-NGT group	non-NGT group	non-NGT group
NGT group	NGT group	NGT group

Primary Outcome Measures

Name	Time	Method
Time to flatus	24 months	It's described as the time patients to get flatus after operation

Secondary Outcome Measures

Name	Time	Method
Pulmonary complication	24 months	It was confirmed by clinical symptoms and CXR
Incisional hernia	24 months	Hernia or separation that occurred through a surgical incision in the abdominal wall deriving either from laparotomy or trocar incisions. All available data will be considered from medical records.
Wound infection	24 months	Superficial or deep surgical-site infections are both considered and should be reported in medical records. Superficial infections are considered when skin or subcutaneous tissue is involved, whereas deep infection is considered when extending into the fascial layer.
Anastomotic leak	24 months	Including any type of Anastomotic leak, pancreatic fistula, bile leakage, etc.
Length of Stay	24 months	Define as the day after surgery to dismiss.
Gastric upset	24 months	Any symptoms described by the subjects.

Trial Locations

Locations (1)

Tongji Hospital; 🇨🇳 Wuhan, Hubei, China