Nasogastric Tube in Pancreatic Surgery

Tongji Hospital50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Nasogastric Tube Decompression Pancreatic Surgery

Interventions

After induction of anesthesia, a 14- or 16-Fr single-lumen NGT was placed in all patients. Its intragastric position was confirmed by intraoperative palpation. Randomization to the NGT or non-NGT group was performed on completion of surgery by computer-generated randomization provided by the supervision department.The NGT was retained until the return of bowel function (passage of flatus or passage of stool) in the patients assigned to the NGT group.

non-NGT groupPROCEDURE

After induction of anesthesia, a 14- or 16-Fr single-lumen NGT was placed in all patients. Its intragastric position was confirmed by intraoperative palpation. Randomization to the NGT or non-NGT group was performed on completion of surgery by computer-generated randomization provided by the supervision department.The NGT was removed in the operation room immediately after the surgery in those assigned to the non-NGT group.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Time to flatus

It's described as the time patients to get flatus after operation

Time frame: 24 months

Secondary Outcomes

Pulmonary complication

It was confirmed by clinical symptoms and CXR

Time frame: 24 months

Wound infection

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.

Time frame: 24 months

Anastomotic leak

Including any type of Anastomotic leak, pancreatic fistula, bile leakage, etc.

Time frame: 24 months

Incisional hernia

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.

Time frame: 24 months

Length of Stay

Define as the day after surgery to dismiss.

Time frame: 24 months

Gastric upset

Any symptoms described by the subjects.

Time frame: 24 months

Nasogastric Tube in Pancreatic Surgery

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts