Link of Interest and Training Model

NCT04341337 | Completed

• 1 other identifier: pipac
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

• The surgical device used to perform PIPAC procedure is commercialized by a single manufacturer under a monopoly regimen, and a formal training (economically supported by the manufacturer) is mandatory for surgeons who want to buy the device.Relations with the company and solutions to extend training require specific analysis from an ethical point of view.
• Based on the growing number of published papers from a growing number of international centers, the controlled training model is not limiting, and it is a successful model of development of this breakthrough innovation.
• But with the major involvement of the industry and the control of training, the different levels of interest could induce ethical questions.

Conditions

Peritoneal Carcinomatosis

Outcome Measures

Primary Outcomes (1)

• qualitative analysis of the interviews

  Questions for interviews were first prepared. Six questions for the clinicians and the scientist were elaborated about the interviewees' experience concerning the initiation and use of PIPAC, difficulties encountered to initiate this activity in their respective centres, description of the involvement of the industry for the development of the technique, the clinician-industry relationship, the mandatory nature of the training, and their ethical judgment on this model. For the biomedical manager, questions were about the set-up of the PIPAC procedure and the implication of the industry in the process. The commercial representative was interviewed about the business strategy of the industry. The interviewer had the freedom to adapt questions to prior answers. Interviewees did not receive the questionnaire before the discussion.

  1 month

Study Arms (1)

expert

interviews of expert of pipac about ethical issues

Other: interview

Interventions

interview OTHER

questionnaire about ethics in surgery

expert

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

expert working in academic tertiary center

You may qualify if:

• expert in pipac
• more than 30 PIPAC per year

Sponsors & Collaborators

• Centre de l'arthrose, Paris: lead

Study Sites (1)

Université de Paris

Paris, 75011, France

Location

Related Publications (1)

• Martellotto S, Maillot C, Villeneuve L, Eveno C, Sgarbura O, Pocard M. Restricted access to innovative surgical technique related to a specific training, is it ethical? Example of the PIPAC procedure. A systematic review and an experts survey. Int J Surg. 2020 Nov;83:235-245. doi: 10.1016/j.ijsu.2020.07.004. Epub 2020 Jul 29.

  PMID: 32738543 DERIVED

MeSH Terms

Conditions

Peritoneal Neoplasms

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Abdominal Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: April 6, 2020
• First Posted: April 10, 2020
• Study Start: March 2, 2019
• Primary Completion: April 6, 2020
• Study Completion: April 6, 2020
• Last Updated: April 29, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)