Cost-Effectiveness of perioperative Vaginally Administered estrogen in postmenopausal women undergoing prolapse surgery (EVA trial): study protocol for a multicenter double-blind randomized placebo-controlled trial.

Autor: Vodegel EV; Department of Obstetrics and Gynecology, Amsterdam University Medical Center - Location AMC, University of Amsterdam, Amsterdam, The Netherlands. e.v.vodegel@amsterdamumc.nl., Zwolsman SE; Department of Obstetrics and Gynecology, Amsterdam University Medical Center - Location AMC, University of Amsterdam, Amsterdam, The Netherlands., Vollebregt A; Department of Obstetrics and Gynecology, Spaarne Gasthuis, Hoofddorp, The Netherlands., Duijnhoven RG; Clinical Trials Unit of the Dutch Society for Obstetrics and Gynecology, Amsterdam, The Netherlands., Bosmans JE; Faculty of Science, Health Economics and Health Technology Assessment, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands., Speksnijder L; Department of Obstetrics and Gynecology, Amphia Ziekenhuis, Breda, The Netherlands., Roos EJ; Department of Obstetrics and Gynecology, Tergooi, Hilversum, The Netherlands., Spaans W; Department of Obstetrics and Gynecology, Maastricht University Medical Center, Maastricht, The Netherlands., Gerards F; Department of Obstetrics and Gynecology, Flevoziekenhuis, Almere, The Netherlands., Adriaanse A; Department of Obstetrics and Gynecology, Noordwest Ziekenhuisgroep, Alkmaar, The Netherlands., Vernooij F; Department of Obstetrics and Gynecology, Diakonessenhuis, Utrecht, The Netherlands., Milani AL; Department of Obstetrics and Gynecology, Reinier de Graaf Gasthuis, Delft, The Netherlands., Sikkema M; Department of Obstetrics and Gynecology, Ziekenhuisgroep Twente, Almelo, The Netherlands., Weemhoff M; Department of Obstetrics and Gynecology, Zuyderland Medisch Centrum, Heerlen, The Netherlands., Mous M; Department of Obstetrics and Gynecology, Alrijne Ziekenhuis, Leiderdorp, The Netherlands., Damoiseaux A; Department of Obstetrics and Gynecology, Catharina Ziekenhuis, Eindhoven, The Netherlands., van Dongen H; Department of Obstetrics and Gynecology, Groene Hart Ziekenhuis, Gouda, The Netherlands., V/D Ploeg M; Department of Obstetrics and Gynecology, Martini Ziekenhuis, Groningen, The Netherlands., Veen J; Department of Obstetrics and Gynecology, Maxima Medisch Centrum, Eindhoven, The Netherlands., van de Pol G; Department of Obstetrics and Gynecology, Gelre Ziekenhuis, Apeldoorn, The Netherlands., Broekman B; Department of Obstetrics and Gynecology, Franciscus Gasthuis & Vlietland, Rotterdam, The Netherlands., Steures P; Department of Obstetrics and Gynecology, Jeroen Bosch Ziekenhuis, 's Hertogenbosch, The Netherlands., Tjin-Asjoe F; Department of Obstetrics and Gynecology, Maasstad Ziekenhuis, Rotterdam, The Netherlands., van der Stege J; Department of Obstetrics and Gynecology, Meander Medisch Centrum, Amersfoort, The Netherlands., Mouw R; Department of Obstetrics and Gynecology, Rijnstate, Arnhem, The Netherlands., van der Vaart CH; Department of Obstetrics and Gynecology, University Medical Center Utrecht, Utrecht, The Netherlands., Roovers JWR; Department of Obstetrics and Gynecology, Amsterdam University Medical Center - Location AMC, University of Amsterdam, Amsterdam, The Netherlands.; Bergman Clinics - Vrouw, Amsterdam, The Netherlands.
Jazyk: angličtina
Zdroj: BMC women's health [BMC Womens Health] 2021 Dec 31; Vol. 21 (1), pp. 439. Date of Electronic Publication: 2021 Dec 31.
DOI: 10.1186/s12905-021-01587-9
Abstrakt: Background: Surgery for pelvic organ prolapse (POP) is associated with high recurrence rates. The costs associated with the treatment of recurrent POP are huge, and the burden from women who encounter recurrent POP, negatively impacts their quality of life. Estrogen therapy might improve surgical outcome for POP due to its potential beneficial effects. It is thought that vaginal estrogen therapy improves healing and long-term maintenance of connective tissue integrity. Hence, this study aims to evaluate the cost-effectiveness of perioperative vaginal estrogen therapy in postmenopausal women undergoing POP surgery.
Methods: The EVA trial is a multi-center double-blind randomized placebo-controlled trial conducted in the Netherlands comparing the effectiveness and costs-effectiveness of vaginal estrogen therapy. This will be studied in 300 postmenopausal women undergoing primary POP surgery, with a POP-Q stage of ≥ 2. After randomization, participants administer vaginal estrogen cream or placebo cream from 4 to 6 weeks preoperative until 12 months postoperative. The primary outcome is subjective improvement of POP symptoms at 1 year follow-up, measured with the Patient Global Impression of Improvement (PGI-I) scale. Secondary outcomes are POP-Q anatomy in all compartments, re-interventions, surgery related complications, general and disease specific quality of life, sexual function, signs and complaints of vaginal atrophy, vaginal pH, adverse events, costs, and adherence to treatment. Follow up is scheduled at 6 weeks, 6 months and 12 months postoperative. Data will be collected using validated questionnaires and out-patient visits including gynecological examination performed by an independent gynecologist.
Discussion: This study investigates whether perioperative vaginal estrogen will be cost-effective in the surgical treatment of POP in postmenopausal women. It is hypothesized that estrogen therapy will show a reduction in recurrent POP symptoms and a reduction in reoperations for POP, with subsequent improved quality of life among women and cost savings. Trial registrationNetherlands Trial Registry: NL6853; registered 19-02-2018, https://www.trialregister.nl/trial/6853 . EudraCT: 2017-003144-21; registered: 24-07-2017.
(© 2021. The Author(s).)
Databáze: MEDLINE
Externí odkaz:
Nepřihlášeným uživatelům se plný text nezobrazuje