Prevention of Chyle-leak After Major Pancreatic Surgery
Schlüsselwörter
Abstrakt
Beschreibung
Patient who come for pancreatic surgery and vein resection/reconstruction will be randomized before surgery in two groups. Intervention group will start the no-fat diet right after surgery, with MCT-oil supplement. Diet will be continued up to 14 days after surgery. The control group will start the diet if chyle leak is diagnosed. Criteria of chyle leak in this study is appearance of milky-coloured fluid from the surgical drains in post-operative day 3 and drain fluids triglyceride levels must be high (>1,5 mmol/l). After enough patients have been recruited in the study, patient records are then analyzed to see if the no-fat diet has any effect on incidence of chyle-leak.
Termine
Zuletzt überprüft: | 01/31/2020 |
Zuerst eingereicht: | 05/14/2017 |
Geschätzte Einschreibung eingereicht: | 05/23/2017 |
Zuerst veröffentlicht: | 05/29/2017 |
Letztes eingereichtes Update: | 02/16/2020 |
Letztes Update veröffentlicht: | 02/17/2020 |
Tatsächliches Startdatum der Studie: | 07/31/2017 |
Geschätztes primäres Abschlussdatum: | 12/30/2025 |
Voraussichtliches Abschlussdatum der Studie: | 12/30/2025 |
Zustand oder Krankheit
Intervention / Behandlung
Dietary Supplement: Diet group
Phase
Armgruppen
Arm | Intervention / Behandlung |
---|---|
Active Comparator: Diet group Diet group will be on no-fat diet including MCT-oil supplement starting right after surgery according to our pancreas ERAS-protocol. | Dietary Supplement: Diet group In the diet, there is no long-chain triglycerides. Fat and protein needs are met with adding medium-chain-fat acid as oil and protein supplements to the diet. Diet has been constructed together with clinical nutrition specialist. |
No Intervention: Normal food-group This study group will follow normal ERAS-protocol after pancreas surgery and start normal diet after surgery. If chyle-leak is diagnosed then it will be treated with the same no-fat diet as the intervention group. |
Zulassungskriterien
Altersberechtigt für das Studium | 18 Years Zu 18 Years |
Studienberechtigte Geschlechter | All |
Akzeptiert gesunde Freiwillige | Ja |
Kriterien | Inclusion Criteria: - Need for a pancreatic resection with vessel resection/reconstruction Exclusion Criteria: - No pancreatic and vessel resection needed - Patients do not want to join the study |
Ergebnis
Primäre Ergebnismaße
1. Chyle-leakage reduced from operating area after surgery [2 weeks after surgery or when patient is released from hospital, in the case of prolonged hospital-stay due to complications, is patient data being analyzed]