Impact of the Absence of Nasogastric Decompression After Pancreaticoduodenectomy (IPOD)

Rennes University Hospital

Status: Completed

Conditions: Digestive System Surgical Procedure; Pancreaticoduodenectomy

Treatments: Device: no nasogastric tube; Device: nasogastric tube

Study type: Interventional

Funder types: Other

Identifiers

NCT02594956

RennesUH

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 125 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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125 participants in 2 patient groups

With Nasogastric Decompression

Active Comparator group

Description:

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.

Treatment:

Device: nasogastric tube

Without Nasogastric decompression

Experimental group

Description:

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

Treatment:

Device: no nasogastric tube