Laparoscopic Sacrocolpopexy with Vaginal Prosthetic Adhesive: Multicenter Prospective Study of 45 Patients

Abstract

Study Objective To evaluate the effectiveness and safety of using a liquid adhesive solution for prosthetic bonding during laparoscopic sacrocolpopexy. Design Multicenter observational prospective study conducted in three French gynecological surgery centers between June 2015 and February 2017. The effectiveness of the intervention was assessed by means of validated symptom and quality of life questionnaires (PFDI-20 including POPDI-6, CRADI-8 & UDI-6, and PISQ-12) and a clinical examination one year after surgery. Setting The medical device used was a compound of pure, fluid, translucent and sterile n-hexyl cyanoacrylate monomers (IFABOND, Peters Chirurgical, France). The glue is applied by means of a cannula. Patients or Participants 45 patients were included from June 2015 to February 2017, with stage 2-4 genital prolapse according to the Pelvic Organ Prolapse Quantification (POP-Q) classification. Interventions A modified laparoscopic sacrocolpopexy using a liquid adhesive solution to fix the prosthesis to the vagina and to the levator ani was performed. Two non-absorbable sutures were performed to attach the anterior prosthesis to the isthmus and promontory. Measurements and Main Results The average operating time was 102.5 minutes (40-210 min) and the average hospitalization time was 2.6 days (0-5 days). At one year, clinical examination and questionnaires were available for 33 and 37/45 patients, respectively (73.3 and 82.2%). The analysis of the PFDI 20 questionnaire revealed an improvement in quality of life with an overall score of 41.5/300 one year after surgery vs 106.3/300 preoperatively (p Conclusion The use of a liquid adhesive solution for prosthetic bonding during sacrocolpopexy appears safe and effective at one year with an improvement in the patient's satisfaction and overall quality of life.