Category
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Primary study
Registry of Trials»Brazilian Registry of Clinical Trials
Year
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2019
INTERVENTION: Cystocele Eighty patients with advanced advanced organ prolapse for surgical treatment will be randomized using two separate commercial screens (UP HOLD x SPLENTIS), , making a total of 40 patients in each group. Selecting the patient, who accepts the eligibility criteria, after signing the Informed Consent Form, or the surgeon selects the type of screen to be used in the surgical procedure, respecting the randomization created by the command = ALEATORIO () of the microsoft program. excel, version 16.0 (ANNEX II). Randomization follows the guidelines of the CONSORT 2010 statement, available at: http://www.consort‐statement.org/. To evaluate vaginal symptoms in women with POP, the ICIQ –VS questionnaire will be used. For patients with urinary incontinence, the ICIQ ‐ SF (International Short Form Incontinence Questionnaire Consultation) questionnaire will be applied. To quantify the individual's intensity and perception of pain, it will be used on the VAS analog scale, being graded according to ordinal scores: no pain (0), mild pain (1 to 2), moderate pain (3 to 5), and pain. intense (6 to 10). For assessment of acceptable satisfaction, the PGI‐I (Global Improvement of Patient Improvement) will be used, being considered satisfied as answers 1 and 2 of the questionnaire. The option of inserting the concomitant mean pressure range was offered to patients who experienced overt stress urinary incontinence or occult stress incontinence, as detected in the urodynamic study. Postoperative follow‐up will be 7 days, 14 days, 30 days, 3 months and 12 months. The evaluation of questionnaires and gynecological examination with POP‐Q evaluation will be applied by professionals not involved in the treatment of patients Pelvic Organ Prolapse Procedure/surgery Uterine Prolapse CONDITION: N00‐N99 Pelvic organ prolapse ; Uterine Prolapse Uterine Prolapse PRIMARY OUTCOME: Expected Outcome 1; ; Surgical success for correction of pelvic organ prolapse at an advanced stage after 1 year of surgery, verified through POP‐Q measurements during postoperative gynecological examination. total vaginal length (C < or = CVT / 3), Ba and Bp points less than ‐1 and no reoperation for vaginal prolapse. Expected Outcome 2; ; Subjective success with improvement in quality of life and absence of symptoms of prolapse vaginal after surgery, verified through the application of questionnaires such as PGI‐I, and answers 1 and 2 were considered as success. SECONDARY OUTCOME: Expected Outcome 1 ; ; Adequate tolerability of postoperative pain with the two techniques used for prolapse correction, verified by the application of the Visual Analog Pain Scale (VAS) at 7, 14 and 30 days postoperatively, being considered adequate control responses 0 (no pain). or 1 and 2 (mild pain). INCLUSION CRITERIA: Adult women, over 45 years old,constituted offspring, with stage III or IV advanced pelvic organ prolapse, treated at a single referral center, at Hospital Municipal e Martenidade Escola ‐ Dr Mário de Moraes Altenfelder Silva ‐ Vila Nova Cachoeirinha.
Epistemonikos ID: 34a5d1a9aba6a87c4f290199670e5755a0b17a2f
First added on: Aug 24, 2024