Evaluation of Circular Staplers in Left-Sided Colorectal Anastomoses
Research type
Research Study
Full title
An Adaptive, Sequential Evaluation of Powered and Manual Circular Staplers in Left-Sided Colorectal Anastomoses
IRAS ID
225197
Contact name
Shazad Ashraf
Contact email
Sponsor organisation
Ethicon Endo-Surgery Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 5 months, 30 days
Research summary
This study is to compare stapler performance issues between commercially available manual staplers and a powered circular stapler in colectomy procedures with left-sided colon anastomosis.
Procedures will be performed according to each hospital's standard-of-care (SOC)and participants will be considered enrolled once their anastomosis has been attempted with a circular stapler.
The study will be conducted in a staged approach. Stage 1, procedures will be performed according to SOC using the surgeon's preferred manual circular stapler. Once this stage is complete, surgeons will move to Stage 2, procedures will be performed according to SOC using the powered circular stapler. Surgeons will complete approximately the same number of procedures in each stage.REC name
West Midlands - Solihull Research Ethics Committee
REC reference
18/WM/0006
Date of REC Opinion
24 Apr 2019
REC opinion
Further Information Favourable Opinion