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Prospective bi-centric randomized open-label study comparing side to side and end to side gastrojejunostomy in pancreaticoduodenectomy
Delayed gastric emptying is one of the main complications occurring after pancreatodudodenectomy, the incidence of which is estimated between 10 and 40% in the literature. Its occurrence leads to an alteration in post-operative quality of life (maintenance or resting of the nasogastric tube) and is the primary reason an increase in the length of hospital stay and therefore the cost of treatment. In addition, it predisposes to the risk of inhalation pneumopathy, which increases the risk of post-operative death. Various technical surgical points have been suggested by retrospective studies to reduce its incidence (pyloric preservation, respect for the left gastric vein, ante-colic positioning of the Child's handle, making a Y-shaped handle) but without ever being validated in randomized prospective studies.
Recently three retrospective studies have highlighted the interest of performing a side to side l rather than an end to side gastro-jejunal anastomosis to reduce the rate of post-operative delayed gastric emptying.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Side to side gastrojejunal reconstruction | Experimental | The post-operative care: usual practise Follow-up: 90 days postoperatively At Day 90:
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| Terminolateral gastrojejunal reconstruction | Active Comparator | The post-operative care: usual practise Follow-up: 90 days postoperatively At Day 90:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reconstruction | Procedure | Lateral gastrojejunal Terminolateral gastrojejunal |
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| Measure | Description | Time Frame |
|---|---|---|
| Post-operative delayed gastric emptying | Occurrence of post-operative delayed gastric emptying (classified to the International Study Group for Pancreatic Surgery (ISGPS)) | Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Clavien-Dindo complications | Up to day 90 | |
| Pancreatic fistula | Occurence of pancreatic fistula (classified according to the ISGPS classification) | Up to day 90 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Paoli Calmettes | Marseille | 13009 | France | |||
| CHU de Rennes |
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| ID | Term |
|---|---|
| D019651 | Plastic Surgery Procedures |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| Biliary fistula | Occurrence of biliary fistula | Up to day 90 |
| Haemorrhage | Occurrence of haemorrhage according to the ISGPS classification | Up to day 90 |
| Food intake (liquid and solid) | 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 |
| Pre-operative to 3-month post-operative weight ratio | Up to day 90 |
| Albumin and prealbumin levels | Up to day 90 |
| General Quality of Life Score for Digestive Pathologies | Up to day 90 |
| Gastrointestinal Quality of Life Index (GIQLI) | Up to day 90 |
| Mortality rate | Day 30 |
| Mortality rate | Day 90 |
| Time to functional recovery (days) after surgery | Functional recovery defined as all of the following:
| Day 90 |
| Rennes |
| 35033 |
| France |