Edilson Benedito de Castro1, Luiz Gustavo O Brito1, Cassia Raquel T Juliato2. 1. Department of Obstetrics and Gynaecology, School of Medical Sciences, University of Campinas (UNICAMP), Rua Alexander Fleming, 101, Cidade Universitária, Campinas, SP, CEP 13083-881, Brazil. 2. Department of Obstetrics and Gynaecology, School of Medical Sciences, University of Campinas (UNICAMP), Rua Alexander Fleming, 101, Cidade Universitária, Campinas, SP, CEP 13083-881, Brazil. cassia.raquel@gmail.com.
Abstract
INTRODUCTION AND HYPOTHESIS: We compared vaginal hysterectomy with bilateral sacrospinous fixation plus an anterior polyvinylidene fluoride mesh versus abdominal sacrocolpopexy for the treatment of primary apical prolapse in postmenopausal women. METHODS: A prospective, randomized, single-blind, parallel study [Registro Brasileiro de Ensaios Clinicos (REBEC) trial register code RBR-7t6rg2] was performed from October 2015 to May 2016. A total of 71 postmenopausal women with advanced pelvic organ prolapse (POP) and undergoing surgery were randomized to the abdominal sacrocolpopexy (ASC) (n = 36) or the vaginal sacrospinous fixation with anterior mesh (VSF-AM) (n = 35) groups. Pelvic Organ Prolapse Quantification (POP-Q) system classification was performed for objective assessment, and the International Consultation on Incontinence Questionnaire-Vaginal Symptoms (ICIQ-VS), International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), and International Consultation on Incontinence Questionnaire Overactive Bladder (ICIQ-OAB) questionnaires were filled out for subjective evaluation by women before and 1 year after surgery. All procedures were performed by a single surgeon. RESULTS: Both groups had improvement in almost POP-Q points (except for vaginal length in the VSF-AM group) and all ICIQ scores. The ASC group had a longer operative time (129 versus 117 min, p = 0.0038) and duration for return to activities (103 versus 57 days, p < .05). Four women (11%) in the VSF-AM group were reoperated versus none from the ASC group (p = .05). CONCLUSIONS: Although the study did not achieve the planned recruitment, after 12 months of follow-up, ASC did not differ from VSF-AM in objective and subjective scores (ICIQ questionnaires; POP-Q measurements). Recovery time was longer after open abdominal surgery.
RCT Entities:
INTRODUCTION AND HYPOTHESIS: We compared vaginal hysterectomy with bilateral sacrospinous fixation plus an anterior polyvinylidene fluoride mesh versus abdominal sacrocolpopexy for the treatment of primary apical prolapse in postmenopausal women. METHODS: A prospective, randomized, single-blind, parallel study [Registro Brasileiro de Ensaios Clinicos (REBEC) trial register code RBR-7t6rg2] was performed from October 2015 to May 2016. A total of 71 postmenopausal women with advanced pelvic organ prolapse (POP) and undergoing surgery were randomized to the abdominal sacrocolpopexy (ASC) (n = 36) or the vaginal sacrospinous fixation with anterior mesh (VSF-AM) (n = 35) groups. Pelvic Organ Prolapse Quantification (POP-Q) system classification was performed for objective assessment, and the International Consultation on Incontinence Questionnaire-Vaginal Symptoms (ICIQ-VS), International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), and International Consultation on Incontinence Questionnaire Overactive Bladder (ICIQ-OAB) questionnaires were filled out for subjective evaluation by women before and 1 year after surgery. All procedures were performed by a single surgeon. RESULTS: Both groups had improvement in almost POP-Q points (except for vaginal length in the VSF-AM group) and all ICIQ scores. The ASC group had a longer operative time (129 versus 117 min, p = 0.0038) and duration for return to activities (103 versus 57 days, p < .05). Four women (11%) in the VSF-AM group were reoperated versus none from the ASC group (p = .05). CONCLUSIONS: Although the study did not achieve the planned recruitment, after 12 months of follow-up, ASC did not differ from VSF-AM in objective and subjective scores (ICIQ questionnaires; POP-Q measurements). Recovery time was longer after open abdominal surgery.
Authors: R C Bump; A Mattiasson; K Bø; L P Brubaker; J O DeLancey; P Klarskov; B L Shull; A R Smith Journal: Am J Obstet Gynecol Date: 1996-07 Impact factor: 8.661
Authors: José Tadeu Nunes Tamanini; Fernando G Almeida; Marcia Eli Girotti; Cássio L Z Riccetto; Paulo C R Palma; Luis Augusto S Rios Journal: Int Urogynecol J Pelvic Floor Dysfunct Date: 2008-05-28
Authors: Cássia R T Juliato; Maira F G Mazzer; Juliana M Diniz; Catarina H S Farias; Edilson B de Castro Journal: Clinics (Sao Paulo) Date: 2016-09 Impact factor: 2.365