Nasogastric Tube in Pancreatic Surgery

NCT ID: NCT03462602

Last Updated: 2018-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2021-05-01

Brief Summary

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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

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Conditions

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Nasogastric Tube Decompression Pancreatic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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NGT group

NGT group

Group Type EXPERIMENTAL

NGT group

Intervention Type 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.

non-NGT group

non-NGT group

Group Type EXPERIMENTAL

non-NGT group

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tongji Hospital

OTHER

Sponsor Role lead

Responsible Party

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Renyi Qin

Clinical professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Renyi Qin, pHD

Role: PRINCIPAL_INVESTIGATOR

Tongji Hospital

Locations

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Tongji Hospital

Wuhan, Hubei, China

Site Status

Countries

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China

Central Contacts

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Hang Zhang, doctor

Role: CONTACT

+8602783665314

Other Identifiers

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TJDBPS04

Identifier Type: -

Identifier Source: org_study_id

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