We are pleased to announce that the Children’s Memorial Health Institute is conducting a project entitled „Comparison of laparoscopic and robotic surgery in selected non-oncological indications in paediatric patients – a randomised controlled trial”, acronym RAMIPS.
The study group will consist of patients diagnosed with gastroesophageal reflux disease (GERD; ICD-10 K21) and choledochal cysts (CC; ICD-10 K83).
Research hypothesis: The use of a surgical robot will reduce the incidence of postoperative complications, shorten hospitalisation time, reduce postoperative pain, increase treatment effectiveness and reduce total treatment costs compared to conventional laparoscopic surgery.
The RAMIPS project is a single-centre, randomised, controlled research experiment with two research arms: one using robotic surgery and the other using conventional laparoscopy. Patients are randomised using a block method to ensure an even distribution between the groups. Patients eligible for the research trial must meet specific inclusion criteria.
Patients, eligible for a research trial, must meet specific inclusion criteria.
The research intervention consists of operations performed using a surgical robot. Robotic operations, used in complex surgical procedures, aim to minimise the invasiveness of the procedure and increase the precision of the operation, which translates into fewer complications and more effective treatment.
The endpoints of the study include:
- Analysis of intraoperative, postoperative and long-term complications,
- Assessment of hospitalisation time,
- Assessment of postoperative pain,
- Assessment of treatment effectiveness,
- Assessment of symptom severity and quality of life, based on GERD questionnaires,
- Comprehensive analysis of treatment-related costs.
The project manager is Dr Grzegorz Kowalewski.
The project is being carried out at the Department of Paediatric Surgery and Organ Transplantation from 31 December 2024 to 30 December 2030.
Project No. 2024/ABM/01/00014 is financed from the state budget by the Medical Research Agency. The total cost of the project and the value of the co-financing is PLN 15,556,566.69.