Digestive System Surgical Procedure, Pancreaticoduodenectomy
Conditions
Keywords
nasogastric decompression
Brief summary
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.
Detailed 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.
Interventions
DEVICEno nasogastric tube
DEVICEnasogastric tube
Sponsors
Rennes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Clavien and Dindo complication ≥ grade II | up to five days after surgery | during hospitalisation to demonstrate the feasibility of the absence of NG decompression after pancreaticoduodenectomy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gastric emptying | up to five days after surgery | occurrence of gastric delayed emptying (classified to the ISGPS classification ) |
| Pancreatic fistula | up to 90 days after surgery | Occurence of pancreatic fistula (classified according to the ISGPS classification) |
| Food intake | up to five days after surgery | Time to oral food intake |
| First gas | up to five days after surgery | Time to the emission of the first gas |
| Pulmonary complication | up to 90 days after surgery | occurrence of pulmonary complication (including atelectasic, pleural effusion, pneumonitis |
| Mortality rate | up to 90 days after surgery | — |
| Hospital stay | up to 90 days after surgery | length of hospital stay |
| Readmission rate | up to 90 days after surgery | — |
| Reinsertion of Nasogastric tube | up to five days after surgery | NG tube reinsertion rate |
Countries
France
Outcome results
None listed