Trial reportTrials2015
Novel ways to explore surgical interventions in randomised controlled trials: applying case study methodology in the operating theatre.
Trial report in Trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
13 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Exploring qualitative methods reported in registered trials and their yields (EQUITY): systematic review.Trials · 2018Pooled it
- Association between Surgical Technical Skills and Clinical Outcomes: A Systematic Literature Review and Meta-Analysis.JSLS : Journal of the Society of Laparoendoscopic SurgeonsPooled it
- How to optimise the use of innovative invasive devices: considerations for feasibility studies.Pilot and feasibility studies · 2026Article
- Developing a surgical trial intervention protocol: using qualitative methods in the operating theatre.Trials · 2025Article
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- Protocol for an open label: phase I trial within a cohort of foetal cell transplants in people with Huntington's disease.Brain communications · 2021Article
- Protocol for developing quality assurance measures to use in surgical trials: an example from the ROMIO study.BMJ open · 2019Article
- Standardizing and monitoring the delivery of surgical interventions in randomized clinical trials.The British journal of surgery · 2016Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
Abstract
backgroundMulti-centre randomised controlled trials (RCTs) in surgery are challenging. It is particularly difficult to establish standards of surgery and ensure that interventions are delivered as intended. This study developed and tested methods for identifying the key components of surgical interventions and standardising interventions within RCTs. Qualitative case studies of surgical interventions were undertaken within the internal pilot phase of a surgical RCT for obesity (the By-Band study). Each case study involved video data capture and non-participant observation of gastric bypass surgery in the operating theatre and interviews with surgeons. Methods were developed to transcribe and synchronise data from video recordings with observational data to identify key intervention components, which were then explored in the interviews with surgeons.
resultsEight qualitative case studies were undertaken. A novel combination of video data capture, observation and interview data identified variations in intervention delivery between surgeons and centres. Although surgeons agreed that the most critical intervention component was the size and shape of the gastric pouch, there was no consensus regarding other aspects of the procedure. They conceded that evidence about the 'best way' to perform bypass was lacking and, combined with the pragmatic nature of the By-Band study, agreed that strict standardisation of bypass might not be required.
conclusionsThis study has developed and tested methods for understanding how surgical interventions are designed and delivered delivered in RCTs. Applying these methods more widely may help identify key components of interventions to be delivered by surgeons in trials, enabling monitoring of key components and adherence to the protocol. These methods are now being tested in the context of other surgical RCTs.
trial registrationCurrent Controlled Trials ISRCTN00786323 , 05/09/2011.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.