Ethics review and clinical trials

Abstract

Author's reply Sir—Hilary Madder and colleagues criticise our study mainly on the grounds that we did not seek ethical approval. Although I totally agree that ethical approval is essential for randomised studies in which the treatment that patients receive is determined at random, I disagree that this was the case in our study. Our patients all received the same treatment—ie, laparoscopic cholecystectomy done in accordance with the Dundee technique1Crosthwaite G Chung T Dunkley P Shimi S Cuschieri A Comparison of direct vision and electronic two-and three-dimensional display systems on surgical task efficiency in endoscopic surgery.Br J Surg. 1995; 82: 849-851Crossref PubMed Scopus (82) Google Scholar by a specialist registrar assisted by one of two consultant surgeons. The randomisation concerned the image display system, either two-dimensional (2D) or three-dimensional (3D). Both systems are in widespread established practice in Europe and North America (and I suspect in Australia). Some surgeons believe that 3D gives a better depth perception, others do not. In laboratory-based randomised studies involving consultants and specialised registrars, we noted and reported no difference between the two systems in terms of task efficiency, task quality, and execution times.2Nathanson LK Shimi S Cuschieri A Laparoscopic cholecystectomy: the Dundee technique.Br J Surg. 1991; 78: 155-159Crossref PubMed Scopus (151) Google Scholar If Madder and colleagues' objection is upheld, then surgeons would have to obtain ethical approval for use of different camera systems, monitors, telescopes, electro-surgical units, and the plethora of ancillary technology used in endoscopic surgery. In UK teaching hospitals, most elective laparoscopic cholecystectomies are done by surgical specialist registrars assisted by consultant surgeons. The patients knows this and the practice is, of course, the cornerstone of apprenticeship surgical training. Moreover, the reported prospective external audit on the training initiative lists set up by the Scottish royal colleges has shown conclusively that postoperative outcome of patients undergoing laparoscopic operations by surgical specialist registrars assisted by consultant tutors is, if anything, better than that reported in publications.3Cuschieri A Wilson RG Sunderland G et al.Training initiative list scheme (TILS) for minimal access therapy: the MATTUS experience.J R Coll Surg Edin. 1997; 42: 295-302PubMed Google Scholar With respect to calculation of sample size, Madder and colleagues are aware that this is based on expected differences. There are no reported clinical data on 2D versus 3D. Laboratory randomised studies by our group showed no difference between the two imaging systems.2Nathanson LK Shimi S Cuschieri A Laparoscopic cholecystectomy: the Dundee technique.Br J Surg. 1991; 78: 155-159Crossref PubMed Scopus (151) Google Scholar As indicated in the report, the ergonomic errors were evenly distributed between the two arms, and only one error results in a material intraoperative complication, when the assisting consultant took over. There were no postoperative complications. The statement by Madder and colleagues that “it is inappropriate to use surgical trainees to evaluate new surgical techniques in a clinical trial” is valid but does not apply to our study since all patients had the same routine well-established operation. The inference from their statement is that all surgical randomised studies should only be carried out by consultant staff. This is surely a highly restrictive policy but, I agree, needs debate. My own view is that the magnitude of the intervention and associated risks should determine the grade of the participating surgeons. All the four specialist registrars were at the end of their higher surgical training (within 1 year of certification). All had training and exposure with both 2D and 3D imaging systems in the Surgical Skills Unit before involvement in the study. The decision not to seek ethical approval was mine since I was and firmly remain convinced that the random allocation did not change the treatment the patients received, the participants were familiar with both imaging systems, and the standard management of these patients was not altered by the conduct of the study. Nonetheless, high-technology assessment in endoscopic surgery needs clarification—should we have ethical approval always or ethical approval when technology alters treatment? Ethics review and clinical trialsThe Lancet does not seem to regard ethics approval as necessary for a prospective trial involving random allocation of patients to different operative conditions for laparoscopic cholecystectomy. G B Hanna and colleagues' investigation (Jan 24, p 248)1 involved comparison of conventional two-dimensional video-endoscopic imaging with a three-dimensional imaging display. The study looked at the influence of each imaging system on the performance of laparoscopic cholecystectomy. The rationale for the study was the absence of objective data showing benefit of three-dimensional imaging systems on clinical practice. Full-Text PDF