Nasogastric Tube in Pancreatic Surgery

Pancreatic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03462602
• Other study ID #: TJDBPS04
• Status: Not yet recruiting
• Phase: N/A
• First received: February 26, 2018
• Last updated: March 5, 2018
• Start date: May 1, 2018
• Est. completion date: May 1, 2021

Study information

• Verified date: March 2018
• Source: Tongji Hospital
• Contact: Hang Zhang, doctor
• Phone: +8602783665314
• Email: okashiiyo[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: May 1, 2021
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nasogastric Tube Decompression
• Pancreatic Surgery

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Tongji Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to flatus	It's described as the time patients to get flatus after operation	24 months
Secondary	Pulmonary complication	It was confirmed by clinical symptoms and CXR	24 months
Secondary	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
Secondary	Anastomotic leak	Including any type of Anastomotic leak, pancreatic fistula, bile leakage, etc.	24 months
Secondary	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
Secondary	Length of Stay	Define as the day after surgery to dismiss.	24 months
Secondary	Gastric upset	Any symptoms described by the subjects.	24 months