FreshRSS

🔒
❌ Acerca de FreshRSS
Hay nuevos artículos disponibles. Pincha para refrescar la página.
AnteayerTus fuentes RSS

Cavitron ultrasonic surgical aspirator (CUSA) compared with conventional pancreatic transection in distal pancreatectomy: study protocol for the randomised controlled CUSA-1 pilot trial

Por: Holze · M. · Loos · M. · Hüttner · F. · Tenckhoff · S. · Feisst · M. · Knebel · P. · Klotz · R. · Mehrabi · A. · Michalski · C. · Pianka · F.
Background

Postoperative pancreatic fistula (POPF) remains the most common and serious complication after distal pancreatectomy. Many attempts at lowering fistula rates have led to unrewarding insignificant results as still up to 30% of the patients suffer from clinically relevant POPF. Therefore, the development of new innovative methods and procedures is still a cornerstone of current surgical research.

The cavitron ultrasonic surgical aspirator (CUSA) device is a well-known ultrasound-based parenchyma transection method, often used in liver and neurosurgery which has not yet been thoroughly investigated in pancreatic surgery, but the first results seem very promising.

Methods

The CUSA-1 trial is a randomised controlled pilot trial with two parallel study groups. This single-centre trial is assessor and patient blinded. A total of 60 patients with an indication for open distal pancreatectomy will be intraoperatively randomised after informed consent. The patients will be randomly assigned to either the control group with conventional pancreas transection (scalpel or stapler) or the experimental group, with transection using the CUSA device. The primary safety endpoint of this trial will be postoperative complications ≥grade 3 according to the Clavien-Dindo classification. The primary endpoint to investigate the effect will be the rate of POPF within 30 days postoperatively according to the ISGPS definition. Further perioperative outcomes, including postpancreatectomy haemorrhage, length of hospital stay and mortality will be analysed as secondary endpoints.

Discussion

Based on the available literature, CUSA may have a beneficial effect on POPF occurrence after distal pancreatectomy. The rationale of the CUSA-1 pilot trial is to investigate the safety and feasibility of the CUSA device in elective open distal pancreatectomy compared with conventional dissection methods and gather the first data on the effect on POPF occurrence. This data will lay the groundwork for a future confirmatory multicentre randomised controlled trial.

Ethics and dissemination

The CUSA-1 trial protocol was approved by the ethics committee of the University of Heidelberg (No. S-098/2022). Results will be published in an international peer-reviewed journal and summaries will be provided in lay language to study participants and their relatives.

Trial registration number

DRKS00027474.

Towards a community-driven definition of community wellbeing: A qualitative study of residents

by Camilla Michalski, Apira Ragunathan, Adrian Foster, Lief Pagalan, Casey Chu, Lori M. Diemert, John F. Helliwell, Diana Urajnik, Ruth Speidel, Tina Malti, Dianne Fierheller, Laura Fusca, Ian Zenlea, Scott McKean, Laura C. Rosella

Background

Understanding what promotes or hinders a community’s capacity to serve the priorities of its residents is essential for the alignment of citizen needs and governance. Participatory approaches that engage community residents on the topic of community wellbeing are useful methods for defining outcomes that reflect a community’s goals and priorities. Using qualitative focus group methods, the aim of this study was to outline bottom-up definitions of community wellbeing from a diverse pool of community residents in Ontario, Canada.

Methods

Semi-structured, two-hour group interviews were conducted with adult (≥18 years) participants (N = 15) residing in four communities across Canada’s largest province of Ontario. Participants were purposively selected from a pool of screening questionnaires to ensure diverse group compositions based on race, gender, age, and educational attainment. Interviews were thematically analysed using descriptive and interpretive methods to characterize resident conceptions of community wellbeing.

Results

Focus group participants were between 18 and 75 years of age and most had lived in their local community for 5 or more years. Four major themes emerged: (1) a sense of community belonging is cultivated through shared spaces, routines, support, and identities; (2) a community constitutes the amenities and social contexts that enable residents to thrive; (3) effective regional decision-making must be community-informed; and (4) the wellbeing of a community relies on equal opportunities for engagement and participation.

Conclusions

Residents described their communities and their associated wellbeing as a combination of accessible amenities and opportunities to engage without marginalization. This study underscores the value of participatory approaches in community wellbeing research, where the viewpoint and life experience of residents is used to inform local decision-making and service delivery. Future research will capture more diverse perspectives towards community belonging, particularly from community newcomers, for the development of regionally appropriate indicators of community wellbeing.

❌