ROMIO feasibility: Randomised controlled trial of minimally invasive or open oesophagectomy

Conditions

Upper Gastro-Intestinal Cancer/oesophageal cancer Cancer Malignant neoplasm of oesophagus

Alexander Harris, James Butterworth, Piers R. Boshier, Hugh Mackenzie, Masanori Tokunaga et al. (23 authors)

Annals of Surgery2020-03-2725 citations

10.1097/sla.0000000000003850

Protocol for developing quality assurance measures to use in surgical trials: an example from the ROMIO study

Natalie Blencowe, Anni Skilton, Daisy Gaunt, Rachel Brierley, Andrew Hollowood et al. (12 authors)

BMJ Open2019-03-0129 citations

10.1136/bmjopen-2018-026209

Comparing open and minimally invasive surgical procedures for oesophagectomy in the treatment of cancer: the ROMIO (Randomised Oesophagectomy: Minimally Invasive or Open) feasibility study and pilot trial.

Metcalfe C, Avery K, Berrisford R, Barham P, Noble SM, Fernandez AM, Hanna G, Goldin R, Elliott J, Wheatley T, Sanders G, Hollowood A, Falk S, Titcomb D, Streets C, Donovan JL, Blazeby JM.

2016-06-0133 citations

10.3310/hta20480

The feasibility of a randomized controlled trial of esophagectomy for esophageal cancer - the ROMIO (Randomized Oesophagectomy: Minimally Invasive or Open) study: protocol for a randomized controlled trial

Kerry Avery, Chris Metcalfe, Richard Berrisford, C P Barham, Jenny Donovan et al. (17 authors)

Trials2014-06-0270 citations

10.1186/1745-6215-15-200

Interventions

Lap-assisted oesophagectomy, This operation will consist of identical steps as described above, but access to the abdominal cavity will be achieved with four or five 10 or 5mm incisions and surgery pe

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male or female patients 2. Over 18 years of age 3. Oesophageal or oesophagogastric junctional adenocarcinoma, squamous cell cancer or high grade dysplasia 4. Endoscopic evidence before treatment of a tumour starting more than 5cm below cricopharyngeus 5. Endoscopic evidence before treatment of a tumour involving less than 4 centimetres of the gastric wall 6. Final tumour stage between high grade dysplasia and T3N1M0 7. Referred for primary oesophagectomy or referred for oesophagectomy after neoadjuvant treatment 8. Able to provide written informed consent

Exclusion criteria

Exclusion criteria: 1. Stage 4 disease 2. Type 3 tumours of the oesophagogastric junction 3. Localised squamous cell cancer who elect to undergo definitive chemoradiotherapy 4. High grade dysplasia who elect to undergo radiofrequency ablation or endoscopic mucosal resection 5. Evidence of previous complex thoracotomies or laparotomies 6. Evidence of previous/concomitant malignancy that would interfere with the study protocol 7. Pregnancy 8. Participating randomised trials that may interfere with this protocol

Design outcomes

Primary

Measure	Time frame
Fatigue (MFI-20); Timepoint(s): 2, 6, 42, 90, 185 days	—

Secondary

Measure	Time frame
1. Bang Blinding Index; Timepoint(s): 2, 6 days 2. HRQL; Timepoint(s): Pre-surgery, 6, 42, 90, 185 days 3. Length of hospital stay; Timepoint(s): day 42 4. Pain; Timepoint(s): Pre-surgery, 2, 3, 6 days 5. Procedural outcome measures; Timepoint(s): Lymph node count, positive resection margins, duration of operation, blood loss - day 42 6. Resource use; Timepoint(s): 6, 42, 90, 185 days 7. Spirometry (lung function); Timepoint(s): Pre-surgery, 3, 6 days 8. Surgical morbidity (Accordian & Clavien-Dindo classifications); Timepoint(s): 2, 3, 6 days 9. Survival time; Timepoint(s): 6 months	—

Measure

Time frame

1. Bang Blinding Index; Timepoint(s): 2, 6 days 2. HRQL; Timepoint(s): Pre-surgery, 6, 42, 90, 185 days 3. Length of hospital stay; Timepoint(s): day 42 4. Pain; Timepoint(s): Pre-surgery, 2, 3, 6 days 5. Procedural outcome measures; Timepoint(s): Lymph node count, positive resection margins, duration of operation, blood loss - day 42 6. Resource use; Timepoint(s): 6, 42, 90, 185 days 7. Spirometry (lung function); Timepoint(s): Pre-surgery, 3, 6 days 8. Surgical morbidity (Accordian & Clavien-Dindo classifications); Timepoint(s): 2, 3, 6 days 9. Survival time; Timepoint(s): 6 months

—

Countries

England, United Kingdom

Outcome results

None listed