Nasogastric Tube in Pancreatic Surgery

Randomized Clinical Trial for Evaluation of the Use of Nasogastric Tube Decompression After Pancreatic Surgery

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 Overview

• Status: Unknown
• Conditions: Pancreatic Surgery; Nasogastric Tube Decompression
• Intervention / Treatment: Procedure: NGT group; Procedure: non-NGT group

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hang Zhang, doctor; Phone Number: +8602783665314; Email: okashiiyo@126.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Tongji Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NGT group	Procedure: NGT group; 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.
Experimental: non-NGT group	Procedure: non-NGT group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to flatus	It's described as the time patients to get flatus after operation	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulmonary complication	It was confirmed by clinical symptoms and CXR	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.	24 months
Anastomotic leak	Including any type of Anastomotic leak, pancreatic fistula, bile leakage, etc.	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.	24 months
Length of Stay	Define as the day after surgery to dismiss.	24 months
Gastric upset	Any symptoms described by the subjects.	24 months

Collaborators and Investigators

• Sponsor: Tongji Hospital
• Investigators: Principal Investigator: Renyi Qin, pHD, Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2018
• Primary Completion (Anticipated): May 1, 2020
• Study Completion (Anticipated): May 1, 2021

Study Registration Dates

• First Submitted: February 26, 2018
• First Submitted That Met QC Criteria: March 5, 2018
• First Posted (Actual): March 12, 2018

Study Record Updates

• Last Update Posted (Actual): March 12, 2018
• Last Update Submitted That Met QC Criteria: March 5, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: TJDBPS04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No