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Results after endoscopic removal of colorectal lesions using an advanced energy device

Speedboat-assisted endoscopic submucosal dissection - clinical outcomes

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN15269750
Enrollment
300
Registered
2023-03-11
Start date
2018-01-01
Completion date
Unknown
Last updated
2023-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Consecutive patients with colorectal polyps referred from the complex polyp multi-disciplinary meeting to remove polyps and prevent bowel cancer Digestive System

Interventions

Endoscopic treatment with submucosal dissection of colorectal polyps. A prospective cohort of colorectal Speedboat-assisted Submucosal Dissection (SSD) cases is initiated for a durati

Sponsors

East Kent Hospitals University NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged >18 years old 2. Lower GI lesion - colon and rectum 3. Lesion of any size and any pathology 4. Discussed in the complex polyp multi-disciplinary with a recommendation to use the ESD technique to remove the lesion 5. Speedboat-assisted ESD technique to be used to remove the lesion

Exclusion criteria

Exclusion criteria: 1. Age <18 years 2. Pregnancy 3. Upper GI lesion - oesophagus, stomach, duodenum and small bowel 4. Lesions removed by other techniques (i.e. not by ESD) as planned by the complex polyp multi-disciplinary meeting 5. Lesions not discussed at the complex polyp multi-disciplinary meeting

Design outcomes

Primary

MeasureTime frame
1. Rate of complete resection: measuring the number of polyps (percentage) that were completely removed en-bloc (in one piece) to the total number of polyps removed. The rate is compared to the standard benchmark rate of >90%. 1.1. Clinical complete resection is identified during the procedure by the complete removal of the lesion as recorded by the operating physician. Data source: Electronic patients' medical records such as Endoscopy reporting software within the Trust - UniSoft from 01/01/2018 till 30/06/2022 and Solus from 01/07/2022 and onwards. Data recorded on the reporting software at the time of the procedure. Data collection between 01/01/2018 to 01/01/2024. 1.2. Histological complete resection is identified during histological examination of the excised lesion by a consultant histopathologic. Data source: Electronic patients' medical records such as Histology reporting software within the Trust - APEX/DART system and Sunrise. Data recorded at the time of histological assessment on APEX. Typically 2-3 weeks after the procedure. Data collection between 01/01/2018 to 01/01/2024. 2. Rate of conversion to piecemeal resection: measuring the number of polyps (percentage) that were NOT completely removed en-bloc (in one piece) to the total number of polyps removed. The rate is compared to the standard benchmark rate of <10%. Conversion to piecemeal is identified during endoscopic excision of the lesion as recorded by the operating physician on the endoscopy report on the day of the procedure. Data source: Endoscopy reporting software, Unisoft from 010/01/2018 and Solus from 01/07/2022 and onwards unitil 01/01/2024. 3. Rate of immediate complications: measuring the number of patients (percentage) who developed one or more of: intra-procedural bleeding (i.e. within 24 hours of the procedure), perforation (tear of the bowel wall), unplanned admission or any other adverse events/unplanned intervention (

Secondary

MeasureTime frame
1. Polyp size/surface/location/morphology as documented on the endoscopy report on the day of the procedure from Unisoft/Solus. From 01/01/2018 till 01/10/2024 1.1. Polyp size: each polyp is measured twice by the operating physician after the resection is completed and by the histopathologist before histological assessment. Two measurements of two axes are taken using a ruler after the lesion is pinned to a cork sheet - the longest axis (axis 1) and the one perpendicular to it (axis 2). Source: Endoscopy reporting system (Unisoft/Solus) recorded at time of procedure AND histology reporting system (Apex - typically within 2-3 weeks of procedure). 1.2. Polyp surface: assuming that most polyps are nearly oval in shape, the formula of oval surface is used to calculate the surface - (Axis 1 * Axis 2)/2 * 3.14 1.3. Polyp location and morphology: identified by the operating physician and recorded on Unisoft/Solus at the time of the procedure. 1.4. Time of procedure: recorded by the operating physician and recorded on Unisoft/Solus at end of the procedure. From 01/01/2018 till 01/01/2024 2. Cost analysis from the hospital and NHS perspective conducted using data from the Finance Department of EKHUFT. Cost analysis will combine data from multiple systems within the Trust to provide cost calculations for each case. Sources are: Patient level data – PAS; Theatre data – Theatreman; Imaging – RIS; Pathology – APEX; Drugs – JAC; Endoscopy – Unisoft/ SOLUS (new system from July 2022). From 01/01/2018 till 01/01/2024

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026