Minimally invasive versus open distal pancreatectomy (LEOPARD): study protocol for a randomized controlled trial

Autor: Rooij, T. de, Hilst, J. van, Vogel, J.A., Santvoort, H.C. van, Boer, M.T. de, Boerma, D., Boezem, P.B. van den, Bonsing, B.A., Bosscha, K., Coene, P.P., Daams, F., Dam, R.M. van, Dijkgraaf, M.G., Eijck, C.H. van, Festen, S., Gerhards, M.F., Koerkamp, B.G., Hagendoorn, J., Harst, E. van der, Hingh, I.H. de, Dejong, C.H., Kazemier, G., Klaase, J., Kleine, R.H. de, Laarhoven, C.J. van, Lips, D.J., Luyer, M.D., Molenaar, I.Q., Nieuwenhuijs, V.B., Patijn, G.A., Roos, D., Scheepers, J.J., Schelling, G.P. van der, Steenvoorde, P., Swijnenburg, R.J., Wijsman, J.H., Abu Hilal, M., Busch, O.R., Besselink, M.G., Dutch Pancreatic Canc Grp
Přispěvatelé: CCA - Cancer Treatment and quality of life, AGEM - Re-generation and cancer of the digestive system, Surgery, Groningen Institute for Organ Transplantation (GIOT), Value, Affordability and Sustainability (VALUE), RS: NUTRIM - R2 - Liver and digestive health, MUMC+: MA Heelkunde (9), RS: NUTRIM - R2 - Gut-liver homeostasis, CCA - Cancer Treatment and Quality of Life, Other departments, APH - Methodology, Clinical Research Unit, Amsterdam Gastroenterology Endocrinology Metabolism
Jazyk: angličtina
Rok vydání: 2017
Předmět:
Time Factors
medicine.medical_treatment
Cost-Benefit Analysis
Health Status
INTERNATIONAL STUDY-GROUP
Distal pancreatectomy
Medicine (miscellaneous)
Administration
Oral
law.invention
Tumours of the digestive tract Radboud Institute for Health Sciences [Radboudumc 14]
Study Protocol
Eating
0302 clinical medicine
Superiority Trial
Randomized controlled trial
Quality of life
Clinical Protocols
Robotic Surgical Procedures
law
SURGERY ISGPS
Pharmacology (medical)
030212 general & internal medicine
Hospital Costs
Laparoscopy
Netherlands
Pain Measurement
Analgesics
Pain
Postoperative
lcsh:R5-920
medicine.diagnostic_test
MALIGNANT-DISEASE
Robot-assisted
3. Good health
Treatment Outcome
Research Design
030220 oncology & carcinogenesis
Pancreatectomy
lcsh:Medicine (General)
Cohort study
medicine.medical_specialty
LONG-TERM
BENIGN
Pancreatic surgery
DUCTAL ADENOCARCINOMA
PANCREATOSPLENECTOMY
CLINICAL-TRIAL
03 medical and health sciences
Laparoscopic
medicine
Journal Article
Humans
IDEAL FRAMEWORK
Minimally invasive
business.industry
Recovery of Function
Pancreatic cancer
Surgery
Clinical trial
DEFINITION
Quality of Life
Observational study
business
Energy Intake
Zdroj: Trials, 18(1):166. BioMed Central
Trials [E], 18(1). BioMed Central
Trials, Vol 18, Iss 1, Pp 1-10 (2017)
Trials, 18:166. BioMed Central Ltd.
de Rooij, T, van Hilst, J, Vogel, J A, van Santvoort, H C, de Boer, M T, Boerma, D, van den Boezem, P B, Bonsing, B A, Bosscha, K, Coene, P P, Daams, F, van Dam, R M, Dijkgraaf, M G, van Eijck, C H, Festen, S, Gerhards, M F, Groot Koerkamp, B, Hagendoorn, J, van der Harst, E, de Hingh, I H, Dejong, C H, Kazemier, G, Klaase, J, de Kleine, R H, van Laarhoven, C J, Lips, D J, Luyer, M D, Molenaar, I Q, Nieuwenhuijs, V B, Patijn, G A, Roos, D, Scheepers, J J, van der Schelling, G P, Steenvoorde, P, Swijnenburg, R J, Wijsman, J H, Abu Hilal, M, Busch, O R, Besselink, M G & for the Dutch Pancreatic Cancer Group 2017, ' Minimally invasive versus open distal pancreatectomy (LEOPARD) : Study protocol for a randomized controlled trial ', Trials, vol. 18, no. 1, 166 . https://doi.org/10.1186/s13063-017-1892-9
TRIALS, 18(166). BMC
Trials, 18
Trials
Trials, 18:166. BioMed Central Ltd
Trials, 18(1). BioMed Central
ISSN: 1745-6215
DOI: 10.1186/s13063-017-1892-9
Popis: Background Observational cohort studies have suggested that minimally invasive distal pancreatectomy (MIDP) is associated with better short-term outcomes compared with open distal pancreatectomy (ODP), such as less intraoperative blood loss, lower morbidity, shorter length of hospital stay, and reduced total costs. Confounding by indication has probably influenced these findings, given that case-matched studies failed to confirm the superiority of MIDP. This accentuates the need for multicenter randomized controlled trials, which are currently lacking. We hypothesize that time to functional recovery is shorter after MIDP compared with ODP even in an enhanced recovery setting. Methods LEOPARD is a randomized controlled, parallel-group, patient-blinded, multicenter, superiority trial in all 17 centers of the Dutch Pancreatic Cancer Group. A total of 102 patients with symptomatic benign, premalignant or malignant disease will be randomly allocated to undergo MIDP or ODP in an enhanced recovery setting. The primary outcome is time (days) to functional recovery, defined as all of the following: independently mobile at the preoperative level, sufficient pain control with oral medication alone, ability to maintain sufficient (i.e. >50%) daily required caloric intake, no intravenous fluid administration and no signs of infection. Secondary outcomes are operative and postoperative outcomes, including clinically relevant complications, mortality, quality of life and costs. Discussion The LEOPARD trial is designed to investigate whether MIDP reduces the time to functional recovery compared with ODP in an enhanced recovery setting. Trial registration Dutch Trial Register, NTR5188. Registered on 9 April 2015 Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-1892-9) contains supplementary material, which is available to authorized users.
Databáze: OpenAIRE
Externí odkaz: