Laparoscopically assisted versus open oesophagectomy for patients with oesophageal cancer-the Randomised Oesophagectomy: Minimally Invasive or Open (ROMIO) study: protocol for a randomised controlled trial (RCT)

被引：32

作者：

Brierley, Rachel C. ^{[1
]}

Gaunt, Daisy ^{[2
]}

Metcalfe, Chris ^{[2
]}

Blazeby, Jane M. ^{[3
,4
]}

Blencowe, Natalie S. ^{[3
,4
]}

Jepson, Marcus ^{[5
]}

Berrisford, Richard G. ^{[6
]}

Avery, Kerry N. L. ^{[5
]}

Hollingworth, William ^{[7
]}

Rice, Caoimhe T. ^{[7
]}

Moure-Fernandez, Aida ^{[7
]}

Wong, Newton ^{[8
]}

Nicklin, Joanna ^{[4
]}

Skilton, Anni ^{[9
]}

Boddy, Alex ^{[10
]}

Byrne, James P. ^{[11
]}

Underwood, Tim ^{[11
]}

Vohra, Ravi ^{[12
]}

Catton, James A. ^{[12
]}

Pursnani, Kish ^{[13
]}

Melhado, Rachel ^{[14
]}

Alkhaffaf, Bilal ^{[14
]}

Krysztopik, Richard ^{[15
]}

Lamb, Peter ^{[16
]}

Culliford, Lucy ^{[1
]}

Rogers, Chris ^{[1
]}

Howes, Benjamin ^{[4
]}

Chalmers, Katy ^{[7
]}

Cousins, Sian ^{[7
]}

Elliott, Jackie ^{[17
]}

Donovan, Jenny ^{[5
]}

Heys, Rachael ^{[1
]}

Wickens, Robin A. ^{[1
]}

Wilkerson, Paul ^{[4
]}

Hollowood, Andrew ^{[4
]}

Streets, Christopher ^{[4
]}

Titcomb, Dan ^{[4
]}

Humphreys, Martyn Lee ^{[6
]}

Wheatley, Tim ^{[6
]}

Sanders, Grant ^{[6
]}

Ariyarathenam, Arun ^{[6
]}

Kelly, Jamie ^{[11
]}

Noble, Fergus ^{[11
]}

Couper, Graeme ^{[16
]}

Skipworth, Richard J. E. ^{[16
]}

Deans, Chris ^{[16
]}

Ubhi, Sukhbir ^{[10
]}

Williams, Robert ^{[10
]}

Bowrey, David ^{[10
]}

Exon, David ^{[10
]}

机构：

[1] Univ Bristol, Clin Trials & Evaluat Unit, Bristol Trials Ctr, Bristol, Avon, England

[2] Univ Bristol, Bristol Randomised Trials Collaborat, Bristol Trials Ctr, Bristol, Avon, England

[3] Univ Bristol, Sch Social & Community Med, Surg Res Ctr, Bristol, Avon, England

[4] Univ Hosp Bristol NHS Fdn Trust, Div Surg, Bristol, Avon, England

[5] Univ Bristol, Sch Social & Community Med, Bristol, Avon, England

[6] Derriford Hosp, Upper GI Surg, Plymouth, Devon, England

[7] Univ Bristol, Bristol Med Sch Populat Hlth Sci, Bristol, Avon, England

[8] Southmead Hosp, North Bristol NHS Trust, Dept Cellular Pathol, Bristol, Avon, England

[9] Univ Hosp Bristol NHS Fdn Trust, Med Illustrat, Bristol, Avon, England

[10] Leicester Royal Infirm, Dept Surg, Leicester, Leics, England

[11] Univ Hosp Southampton NHS Fdn Trust, Div Surg, Southampton, Hants, England

[12] City Hosp Nottingham, Dept Gen Surg, Nottingham, England

[13] Royal Preston Hosp, Dept Upper GI Surg, Preston, Lancs, England

[14] Salford Royal NHS Fdn Trust, Dept Oesophagogastr Surg, Salford, Lancs, England

[15] Royal United Hosp Bath NHS Trust, Dept Gastroenterol, Bath, Avon, England

[16] Royal Infirm Edinburgh NHS Trust, Gen Surg Dept, Edinburgh, Midlothian, Scotland

[17] Gastrooesophageal Support & Help Grp, Bristol, Avon, England

来源：

BMJ OPEN | 2019年 / 9卷 / 11期

基金：

英国医学研究理事会;

关键词：

QUALITY-OF-LIFE; OUTCOMES; COMPLICATIONS; INSTRUMENT; SURGERY;

D O I：

10.1136/bmjopen-2019-030907

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Introduction Surgery (oesophagectomy), with neoadjuvant chemo(radio)therapy, is the main curative treatment for patients with oesophageal cancer. Several surgical approaches can be used to remove an oesophageal tumour. The Ivor Lewis (two-phase procedure) is usually used in the UK. This can be performed as an open oesophagectomy (OO), a laparoscopically assisted oesophagectomy (LAO) or a totally minimally invasive oesophagectomy (TMIO). All three are performed in the National Health Service, with LAO and OO the most common. However, there is limited evidence about which surgical approach is best for patients in terms of survival and postoperative health-related quality of life. Methods and analysis We will undertake a UK multicentre randomised controlled trial to compare LAO with OO in adult patients with oesophageal cancer. The primary outcome is patient-reported physical function at 3 and 6 weeks postoperatively and 3 months after randomisation. Secondary outcomes include: postoperative complications, survival, disease recurrence, other measures of quality of life, spirometry, success of patient blinding and quality assurance measures. A cost-effectiveness analysis will be performed comparing LAO with OO. We will embed a randomised substudy to using a multi-level regression model. Patients will be monitored for up to 3 years after their surgery.

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