Impact of the Absence of Nasogastric Decompression After Pancreaticoduodenectomy

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

COMPLETED

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-16

Study Completion Date

2018-12-05

Brief Summary

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The use of nasogastric (NG) decompression after pancreaticoduodenectomy (PD) is a current practice. NG tube is associated with a high rate of morbidity including pulmonary morbidity, delayed gastric emptying and finally an increased length of hospital stay.

The absence of NG decompression could be the corner stone of the concept of the enhanced recovery program after PD.

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Detailed Description

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The use of nasogastric (NG) decompression after pancreaticoduodenectomy (PD) is a current practice. NG tube is associated with a high rate of morbidity including pulmonary morbidity, delayed gastric emptying and finally an increased length of hospital stay. In the era of the enhance recovery after major abdominal surgery, the place of the NG tube remains unproven after PD even if NG tube is clearly abandoned in liver, stomach and colonic surgery. Nowadays, only few retrospective series had reported the feasibility of the absence of nasogastric tube after PD, but not with a randomized control trial. The absence of NG decompression could be the corner stone of the concept of the enhanced recovery program after PD.

The objective of this prospective randomized monocentric study is to evaluate the impact of the absence of NG decompression after PD.

The aim of the study is to decrease postoperative morbidity after PD including pulmonary and delayed gastric emptying complication. The impact of the absence of systematic NG decompression could be interesting in terms of public health with a decreased of length of hospital stay. Furthermore, this is the first randomized study comparing NG tube decompression after PD to absence of NG tube after PD which would bring relevant elements to improve the recovery after PD.

Conditions

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Digestive System Surgical Procedure Pancreaticoduodenectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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With Nasogastric Decompression

This group will receive conventional care according to the protocol of the service in place with removal of the nasogastric tube the 3rd postoperative day if the flow is \< 500ml / 24h, if not removal will take place on the 5th postoperative day.

Group Type ACTIVE_COMPARATOR

nasogastric tube

Intervention Type DEVICE

Without Nasogastric decompression

The nasogastric tube will be take off at the end of the surgery, just after the extubation.

Group Type EXPERIMENTAL

no nasogastric tube

Intervention Type DEVICE

Interventions

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no nasogastric tube

Intervention Type DEVICE

nasogastric tube

Intervention Type DEVICE

Other Intervention Names

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no double lumen nasogastric tube double lumen nasogastric tube

Eligibility Criteria

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Inclusion Criteria

* Age \> 18 years and ≤ 75 years
* patient requiring a PD for benign of malign pathology of the bilio and pancreatic intersection
* patient giving free and informed consent

Exclusion Criteria

* previous gastric of esophagus surgery
* sever comorbidity such as : end stage renal disease, respiratory failure, heart failure (≥ 3 NYHA)
* Person with a measure of legal protection (guardianship)
* Pregnant woman or nursing mother

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No