A Sauerwald1, L Langer2,3, D Ratiu3, A Prescher4, M Scaal5, G K Noé6, K Wegmann7, D R Bulian8, C Eichler9,10. 1. Department of Gynecology and Obstetrics, St. Marien-Hospital, Düren, Germany. 2. Breast Cancer Center, Municipal Hospital Holweide, Cologne, Germany. 3. Department of Obstetrics and Gynecology, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany. 4. Department of Anatomy, RWTH Aachen University, Aachen, Germany. 5. Department of Anatomy, University of Cologne, Cologne, Germany. 6. Department of Gynecology and Obstetrics, Hospital Rhein-Kreis-Neuss, Faculty University of Witten/Herdecke, Witten, Germany. 7. Center for Orthopedic and Trauma Surgery, University Medical Center, Cologne, Germany. 8. Department of Abdominal, Vascular and Transplant Surgery Cologne-Merheim Medical Center (CMMC), Witten/Herdecke University, Witten, Germany. 9. Department of Obstetrics and Gynecology, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany. ceichler@gmail.com. 10. Brustzentrum der Universitätsfrauenklinik Köln, Kerpener Straße 34, 50931, Cologne, Germany. ceichler@gmail.com.
Abstract
INTRODUCTION: Pectopexy, a laparoscopic method for prolapse surgery, showed promising results in previous transient testing by this group. It was shown that a single suture, yielding an ultimate load of 35 N, was equivalent to continuous suturing. This was demonstrated in an in vitro cadaver study. This transient data were used to establish an elastic stress-strain envelope. It was now possible to proceed to dynamic in vitro analysis of this surgical method to establish time to functional stability. METHODS: Cyclic testing of this fixation method was performed on human female embalmed cadaver (cohort 1) and fresh, non-embalmed cadaver (cohort 2) pelvises. The testing envelope was 5-25 N at a speed of 1 mm/s. 100 load regulated cycles were applied. RESULTS: 100 cycles were completed with each model; no overall system failure occurred. Steady state, i.e., functional stability was reached after 14.5 (± 2.9) cycles for the embalmed group and after 19.1 (± 7.2) cycles for the non-embalmed group. This difference was statistically significant p = 0.00025. CONCLUSION: This trial showed in an in vitro cyclic testing of the pectopexy method that functional stability may be achieved after no more than 19.1 cycles of load exposure. When remaining within the established load envelope of below 25 N, patients do not need to fear global fixation failure. Testing did demonstrate differences in non-embalmed and embalmed cadaver testing. Embalmed cadaver testing tends to underestimate time to steady state by 26.3%.
INTRODUCTION: Pectopexy, a laparoscopic method for prolapse surgery, showed promising results in previous transient testing by this group. It was shown that a single suture, yielding an ultimate load of 35 N, was equivalent to continuous suturing. This was demonstrated in an in vitro cadaver study. This transient data were used to establish an elastic stress-strain envelope. It was now possible to proceed to dynamic in vitro analysis of this surgical method to establish time to functional stability. METHODS: Cyclic testing of this fixation method was performed on human female embalmed cadaver (cohort 1) and fresh, non-embalmed cadaver (cohort 2) pelvises. The testing envelope was 5-25 N at a speed of 1 mm/s. 100 load regulated cycles were applied. RESULTS: 100 cycles were completed with each model; no overall system failure occurred. Steady state, i.e., functional stability was reached after 14.5 (± 2.9) cycles for the embalmed group and after 19.1 (± 7.2) cycles for the non-embalmed group. This difference was statistically significant p = 0.00025. CONCLUSION: This trial showed in an in vitro cyclic testing of the pectopexy method that functional stability may be achieved after no more than 19.1 cycles of load exposure. When remaining within the established load envelope of below 25 N, patients do not need to fear global fixation failure. Testing did demonstrate differences in non-embalmed and embalmed cadaver testing. Embalmed cadaver testing tends to underestimate time to steady state by 26.3%.