Nasogastric Tube in Pancreatic Surgery

NCT03462602 | Unknown DMC

• 1 other identifier: TJDBPS04
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasogastric Tube Decompression; Pancreatic Surgery

Outcome Measures

Primary Outcomes (1)

• Time to flatus

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

  24 months

Secondary Outcomes (6)

• Pulmonary complication

  24 months

• Wound infection

  24 months

• Anastomotic leak

  24 months

• Incisional hernia

  24 months

• Length of Stay

  24 months

Study Arms (2)

NGT group

EXPERIMENTAL

NGT group

Procedure: NGT group

non-NGT group

EXPERIMENTAL

non-NGT group

Procedure: non-NGT group

Interventions

NGT group PROCEDURE

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.

NGT group

non-NGT group PROCEDURE

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.

non-NGT group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430000, China

Location

Study Officials

• Renyi Qin, pHD

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hang Zhang, doctor

CONTACT

+8602783665314; okashiiyo@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: March 12, 2018
• Study Start: May 1, 2018
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2021
• Last Updated: March 12, 2018

Record last verified: 2018-03

Locations

CN (1)