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Completed

NCT Number: NCT02594956

Impact of the Absence of Nasogastric Decompression After Pancreaticoduodenectomy

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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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire Rennes Pontchaillou

Rennes, 35000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

no nasogastric tube

Device

Other names: no double lumen nasogastric tube

Nasogastric tube

Device

Other names: double lumen nasogastric tube

Primary outcomes

  1. Occurrence of Clavien and Dindo complication ≥ grade II

    Time frame: up to five days after surgery

    during hospitalisation to demonstrate the feasibility of the absence of NG decompression after pancreaticoduodenectomy

Secondary outcomes

  1. Pulmonary complication

    Time frame: up to 90 days after surgery

    occurrence of pulmonary complication (including atelectasic, pleural effusion, pneumonitis

  2. Gastric emptying

    Time frame: up to five days after surgery

    occurrence of gastric delayed emptying (classified to the ISGPS classification )

  3. Pancreatic fistula

    Time frame: up to 90 days after surgery

    Occurence of pancreatic fistula (classified according to the ISGPS classification)

  4. Food intake

    Time frame: up to five days after surgery

    Time to oral food intake

  5. First gas

    Time frame: up to five days after surgery

    Time to the emission of the first gas

  6. Reinsertion of Nasogastric tube

    Time frame: up to five days after surgery

    NG tube reinsertion rate

  7. Reinsertion of Nasogastric tube

    Time frame: up to five days after surgery

    NG tube reinsertion time

  8. Reinsertion of Nasogastric tube

    Time frame: up to five days after surgery

    NG tube reinsertion for gastroparesis or reintubation

  9. Mortality rate

    Time frame: up to 90 days after surgery

  10. Hospital stay

    Time frame: up to 90 days after surgery

    length of hospital stay

  11. Readmission rate

    Time frame: up to 90 days after surgery

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Official study title

Impact of the Absence of Nasogastric Decompression After Pancreaticoduodenectomy : A Prospective and Randomized Study

Acronym: IPOD

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Nov 3, 2015
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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