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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| With Nasogastric Decompression | Active Comparator | 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. |
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| Without Nasogastric decompression | Experimental | The nasogastric tube will be take off at the end of the surgery, just after the extubation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| no nasogastric tube | Device |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Clavien and Dindo complication ≥ grade II | during hospitalisation to demonstrate the feasibility of the absence of NG decompression after pancreaticoduodenectomy | up to five days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary complication | occurrence of pulmonary complication (including atelectasic, pleural effusion, pneumonitis | up to 90 days after surgery |
| Gastric emptying | occurrence of gastric delayed emptying (classified to the ISGPS classification ) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laurent Sulpice, MD/PH/prof | Rennes UH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire Rennes Pontchaillou | Rennes | 35000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32667635 | Derived | Bergeat D, Merdrignac A, Robin F, Gaignard E, Rayar M, Meunier B, Beloeil H, Boudjema K, Laviolle B, Sulpice L. Nasogastric Decompression vs No Decompression After Pancreaticoduodenectomy: The Randomized Clinical IPOD Trial. JAMA Surg. 2020 Sep 1;155(9):e202291. doi: 10.1001/jamasurg.2020.2291. Epub 2020 Sep 16. |
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| ID | Term |
|---|---|
| D004750 | Enteral Nutrition |
| ID | Term |
|---|---|
| D005248 | Feeding Methods |
| D013812 | Therapeutics |
| D018529 | Nutritional Support |
| D044623 | Nutrition Therapy |
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| nasogastric tube |
| Device |
|
|
| up to five days after surgery |
| Pancreatic fistula | Occurence of pancreatic fistula (classified according to the ISGPS classification) | up to 90 days after surgery |
| Food intake | Time to oral food intake | up to five days after surgery |
| First gas | Time to the emission of the first gas | up to five days after surgery |
| Reinsertion of Nasogastric tube | NG tube reinsertion rate | up to five days after surgery |
| Reinsertion of Nasogastric tube | NG tube reinsertion time | up to five days after surgery |
| Reinsertion of Nasogastric tube | NG tube reinsertion for gastroparesis or reintubation | up to five days after surgery |
| Mortality rate | up to 90 days after surgery |
| Hospital stay | length of hospital stay | up to 90 days after surgery |
| Readmission rate | up to 90 days after surgery |