WOFAPS 2025 8th World Congress of Pediatric Surgery

Lidya-Olgu Durmaz ¹, Eva Ana Menke ¹, Gerhard Schmidt ², Matthias Burmeister ², Robert Bergholz ¹, Thomas Franz Krebs ³

¹ Department of General, Visceral, Thoracic, Transplant and Pediatric Surgery, University Hospital Schleswig-Holstein (UKSH), Kiel, Germany
² Department of Electrical Information Engineering, Faculty of Engineering, Kiel University, Kiel, Germany
³ Department of Pediatric Surgery, Children’s Hospital of Eastern Switzerland, St. Gallen, Switzerland

Purpose
Gastroschisis, a congenital malformation involving the herniation of intestines through a abdominal wall defect, has two subtypes: simple (without additional anomalies) and complex (associated with complications and higher mortality). Previous animal studies suggested that fetoscopic coverage of gastroschisis could benefit the outcome, but technical challenges, especially in securing the covering bag, have limited the feasibility. This study evaluated a new instrument prototype for improved bag fixation.

Method
Based on a systematic literature research, published as a review article, a prototype for fetoscopic coverage was developed and validated in a self-made avital uterine model using a 25-week of gestation simulator. The bag was sutured to the simulated defect without or with the prototype, with each knot set consisting of four knots. Knotting times for each individual suture were recorded. Subjective assessments of ease of use (Likert scale), satisfaction (Likert scale), and usability (System Usability Scale, SUS) were collected via questionnaires. Statistical analysis of quantitative data and qualitative evaluation were performed.

Results
Out of 181 knots, 132 paired knotting times were analyzed (median: 118.5 seconds manually vs. 120.5 seconds with the prototype). No significant differences in times were found (p>0.7). However, satisfaction increased with experience, particularly using the prototype (p=0.008). The System Usability Scale score improved to 69.77 in the second session, indicating moderate usability.

Conclusion
While the prototype did not significantly reduce knotting times, it enhanced bag fixation without dislocations. These advantages could improve fetal surgery under amnioinfusion compared to partial carbon dioxide insufflation. Increased satisfaction likely reflects a learning effect. The SUS score suggests potential for prototype optimization. Therefore, a new generation of the prototype with enhanced functionality was developed. Further research is required to conduct the new prototype in an underwater setup, starting with non-vital conditions and later in animal models.