Centre Hospitalier Universitaire Rennes Pontchaillou
Rennes, 35000, France
NCT Number: NCT02594956
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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Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Rennes, 35000, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: no double lumen nasogastric tube
Other names: double lumen nasogastric tube
Time frame: up to five days after surgery
during hospitalisation to demonstrate the feasibility of the absence of NG decompression after pancreaticoduodenectomy
Time frame: up to 90 days after surgery
occurrence of pulmonary complication (including atelectasic, pleural effusion, pneumonitis
Time frame: up to five days after surgery
occurrence of gastric delayed emptying (classified to the ISGPS classification )
Time frame: up to 90 days after surgery
Occurence of pancreatic fistula (classified according to the ISGPS classification)
Time frame: up to five days after surgery
Time to oral food intake
Time frame: up to five days after surgery
Time to the emission of the first gas
Time frame: up to five days after surgery
NG tube reinsertion rate
Time frame: up to five days after surgery
NG tube reinsertion time
Time frame: up to five days after surgery
NG tube reinsertion for gastroparesis or reintubation
Time frame: up to 90 days after surgery
Time frame: up to 90 days after surgery
length of hospital stay
Time frame: up to 90 days after surgery
Rennes University Hospital
Other
Impact of the Absence of Nasogastric Decompression After Pancreaticoduodenectomy : A Prospective and Randomized Study
Acronym: IPOD
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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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