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

Not Applicable

Completed

• Conditions: pper Gastro-Intestinal Cancer/oesophageal cancer; Cancer; Malignant neoplasm of oesophagus

• Registration Number: ISRCTN59036820
• Lead Sponsor: niversity of Bristol (UK)

Brief Summary

2014 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/24888266 protocol 2016 Results article in http://www.ncbi.nlm.nih.gov/pubmed/27373720 results 2019 Protocol article in https://pubmed.ncbi.nlm.nih.gov/30826769 quality assurance protocol (added 30/03/2020)

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02-25
• Study Completion: 2016-10-21
• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 273

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fatigue (MFI-20); Timepoint(s): 2, 6, 42, 90, 185 days

Secondary Outcome Measures

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