Eva Dahlgren1, Preben Kjølhede. 1. Department of Obstetrics and Gynecology, Institute of Clinical Sciences, Sahlgrenska Academy, Gothenburg University, Gothenburg, Sweden. Eva.Dahlgren@vgregion.se
Abstract
OBJECTIVE: To determine the long-term objective and subjective outcomes of use of a porcine skin graft (Pelvicol) compared with conventional colporrhaphy in recurrent pelvic organ prolapse surgery and to analyze risk factors and safety. DESIGN: Open randomized controlled multicenter study. SETTING:Eight Swedish hospitals. POPULATION: 135 consecutive women with recurrent cystocele and/orrectocele admitted for vaginal prolapse surgery; 132 completed the study, 64 were randomly allocated to receive conventional colporrhaphy and 68 to Pelvicol. METHODS:Conventional anterior and posterior colporrhaphy and colporrhaphy with use of Pelvicol mesh reinforcement. Clinical evaluation by means of pelvic organ prolapse quantification (POP-Q) and symptom questionnaire preoperatively, three months and three years postoperatively. MAIN OUTCOME MEASURES: Anatomical and subjective outcome. Recurrence was defined as POP-Q ≥ stage 2. RESULTS: At three-month follow-up, early recurrence/surgical failures occurred significantly more often in the Pelvicol group, but at the three-year follow-up the recurrence rates were similar. The recurrence rates in the anterior compartment were 57-62% and 44-23% in the posterior compartment for the colporrhaphy and Pelvicol groups, respectively. Symptoms were substantially and equally reduced in the two groups after surgery. Sexual activity and function did not seem to be affected adversely in any group. The complication rate was low. Risk factors for anatomical recurrence were age, body mass index and preoperative stage of the prolapse. CONCLUSIONS: With the surgical technique used in this study, Pelvicol did not provide advantages over conventional colporrhaphy in recurrent pelvic organ prolapse concerning anatomical and subjective outcomes.
RCT Entities:
OBJECTIVE: To determine the long-term objective and subjective outcomes of use of a porcine skin graft (Pelvicol) compared with conventional colporrhaphy in recurrent pelvic organ prolapse surgery and to analyze risk factors and safety. DESIGN: Open randomized controlled multicenter study. SETTING: Eight Swedish hospitals. POPULATION: 135 consecutive women with recurrent cystocele and/or rectocele admitted for vaginal prolapse surgery; 132 completed the study, 64 were randomly allocated to receive conventional colporrhaphy and 68 to Pelvicol. METHODS: Conventional anterior and posterior colporrhaphy and colporrhaphy with use of Pelvicol mesh reinforcement. Clinical evaluation by means of pelvic organ prolapse quantification (POP-Q) and symptom questionnaire preoperatively, three months and three years postoperatively. MAIN OUTCOME MEASURES: Anatomical and subjective outcome. Recurrence was defined as POP-Q ≥ stage 2. RESULTS: At three-month follow-up, early recurrence/surgical failures occurred significantly more often in the Pelvicol group, but at the three-year follow-up the recurrence rates were similar. The recurrence rates in the anterior compartment were 57-62% and 44-23% in the posterior compartment for the colporrhaphy and Pelvicol groups, respectively. Symptoms were substantially and equally reduced in the two groups after surgery. Sexual activity and function did not seem to be affected adversely in any group. The complication rate was low. Risk factors for anatomical recurrence were age, body mass index and preoperative stage of the prolapse. CONCLUSIONS: With the surgical technique used in this study, Pelvicol did not provide advantages over conventional colporrhaphy in recurrent pelvic organ prolapse concerning anatomical and subjective outcomes.
Authors: William D Winkelman; Annliz Macharia; Sonya Bharadwa; Maheetha Bharadwaj; Michele R Hacker; Peter L Rosenblatt Journal: Female Pelvic Med Reconstr Surg Date: 2021-02-01 Impact factor: 2.091