2 results on '"Primrose, John N."'
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2. Laparoscopic versus open resections in the posterosuperior liver segments within an enhanced recovery programme (ORANGE Segments): study protocol for a multicentre randomised controlled trial
- Author
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Christoph, Kuemmerli, Robert S, Fichtinger, Alma, Moekotte, Luca A, Aldrighetti, Somaiah, Aroori, Marc G H, Besselink, Mathieu, D'Hondt, Rafael, Díaz-Nieto, Bjørn, Edwin, Mikhail, Efanov, Giuseppe M, Ettorre, Krishna V, Menon, Aali J, Sheen, Zahir, Soonawalla, Robert, Sutcliffe, Roberto I, Troisi, Steven A, White, Lloyd, Brandts, Gerard J P, van Breukelen, Jasper, Sijberden, Siân A, Pugh, Zina, Eminton, John N, Primrose, Ronald, van Dam, Mohammed Abu, Hilal, Surgery, CCA - Cancer Treatment and Quality of Life, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, RS: NUTRIM - R2 - Liver and digestive health, MUMC+: KIO Kemta (9), RS: GROW - R1 - Prevention, RS: CAPHRI - R1 - Ageing and Long-Term Care, RS: CAPHRI - R6 - Promoting Health & Personalised Care, FPN Methodologie & Statistiek, FHML Methodologie & Statistiek, RS: FPN M&S I, RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, MUMC+: MA Heelkunde (9), Kuemmerli, C., Fichtinger, R. S., Moekotte, A., Aldrighetti, L. A., Aroori, S., Besselink, M. G. H., D'Hondt, M., Diaz-Nieto, R., Edwin, B., Efanov, M., Ettorre, G. M., Menon, K. V., Sheen, A. J., Soonawalla, Z., Sutcliffe, R., Troisi, R., White, S. A., Brandts, L., van Breukelen, G. J. P., Sijberden, J., Pugh, S. A., Eminton, Z., Primrose, J. N., van Dam, R., Hilal, M. A., Kuemmerli, Christoph, Fichtinger, Robert S, Moekotte, Alma, Aldrighetti, Luca A, Aroori, Somaiah, Besselink, Marc G H, D'Hondt, Mathieu, Díaz-Nieto, Rafael, Edwin, Bjørn, Efanov, Mikhail, Ettorre, Giuseppe M, Menon, Krishna V, Sheen, Aali J, Soonawalla, Zahir, Sutcliffe, Robert, Troisi, Roberto I, White, Steven A, Brandts, Lloyd, van Breukelen, Gerard J P, Sijberden, Jasper, Pugh, Siân A, Eminton, Zina, Primrose, John N, van Dam, Ronald, and Hilal, Mohammed Abu
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CLINICAL-OUTCOMES ,SURGERY ,Medicine (miscellaneous) ,BODY-IMAGE ,Hepatectomy/adverse effects ,Liver Neoplasms/surgery ,PROGNOSTIC-FACTORS ,QUALITY-OF-LIFE ,HEPATOCELLULAR-CARCINOMA ,Hepatectomy ,Humans ,Multicenter Studies as Topic ,Pharmacology (medical) ,Liver surgery ,Enhanced recovery ,Randomized Controlled Trials as Topic ,Randomised controlled trial ,Liver Neoplasms ,SEVERITY GRADING SYSTEM ,PARENCHYMAL-SPARING RESECTIONS ,Length of Stay ,Posterosuperior segments ,Posterosuperior segment ,METASTASES ,Treatment Outcome ,Laparoscopy/adverse effects ,DIFFICULTY ,Quality of Life ,Laparoscopy ,Human - Abstract
Background A shift towards parenchymal-sparing liver resections in open and laparoscopic surgery emerged in the last few years. Laparoscopic liver resection is technically feasible and safe, and consensus guidelines acknowledge the laparoscopic approach in the posterosuperior segments. Lesions situated in these segments are considered the most challenging for the laparoscopic approach. The aim of this trial is to compare the postoperative time to functional recovery, complications, oncological safety, quality of life, survival and costs after laparoscopic versus open parenchymal-sparing liver resections in the posterosuperior liver segments within an enhanced recovery setting. Methods The ORANGE Segments trial is an international multicentre randomised controlled superiority trial conducted in centres experienced in laparoscopic liver resection. Eligible patients for minor resections in the posterosuperior segments will be randomised in a 1:1 ratio to undergo laparoscopic or open resections in an enhanced recovery setting. Patients and ward personnel are blinded to the treatment allocation until postoperative day 4 using a large abdominal dressing. The primary endpoint is time to functional recovery. Secondary endpoints include intraoperative outcomes, length of stay, resection margin, postoperative complications, 90-day mortality, time to adjuvant chemotherapy initiation, quality of life and overall survival. Laparoscopic liver surgery of the posterosuperior segments is hypothesised to reduce time to functional recovery by 2 days in comparison with open surgery. With a power of 80% and alpha of 0.04 to adjust for interim analysis halfway the trial, a total of 250 patients are required to be randomised. Discussion The ORANGE Segments trial is the first multicentre international randomised controlled study to compare short- and long-term surgical and oncological outcomes of laparoscopic and open resections in the posterosuperior segments within an enhanced recovery programme. Trial registration ClinicalTrials.gov NCT03270917. Registered on September 1, 2017. Before start of inclusion. Protocol version: version 12, May 9, 2017
- Published
- 2021
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