Laparoscopic Pectopexy and Laparoscopic Colporrhaphies in Pelvic Organ Prolapse Treatment
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Vaginal Vault Prolapse, Uterine Prolapse, Cystocele, Midline, Rectocele; Female. Базовые параметры: 18 лет — 79 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Финляндия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
This prospective cohort study investigates the surgical outcomes of laparoscopic pectopexy and laparoscopic colporraphy performed at the Wellbeing Services County of South Ostrobothnia. The primary outcome measure is to assess changes in sensation of bulge and pressure. Secondary outcome measures include evaluating other prolapse symptoms and pain, quality of life, anatomical correction of prolapse, surgical safety parameters, and postoperative complications. Approximately 40-50 laparoscopic pectopexies will be performed over two years by a single experienced surgeon. The study requires preoperative and postoperative assessments, including standardized patient questionnaires and anatomical measurements.
Подробное описание
The study aims to evaluate the effects of laparoscopic pectopexy and colporraphy on pelvic organ prolapse (POP) symptoms, anatomical prolapse repair, and surgical outcomes. The primary outcome measure is the presence of a bulging sensation 12 months after surgery. Secondary outcome measure includes additional prolapse-related symptoms, residual urine volume, pelvic pain, urinary incontinence, and safety parameters such as intraoperative blood loss and complications. Anatomical correction will be assessed using the Pelvic Organ Prolapse Quantification (POP-Q) system.
All surgical procedures will be performed by a single experienced surgeon with over five years of experience and more than 100 laparoscopic pectopexies performed. Patients will undergo laparoscopic pectopexy, with or without concomitant anterior and posterior vaginal wall repair using sutures. The pectopexy procedure utilizes a 3x15 cm Dynamesh PRP PVDF mesh, secured with absorbable monofilament thread to the vaginal cuff or with non-absorbable multifilament sutures to the uterine cervical stump.
Первичные конечные точки
- Patient-reported postoperative sensation of bulging at 12 months postoperatively [Срок оценки: From the enrollment til follow-up visit at 12 months postoperatively]
Вторичные конечные точки (12)
- Change in Pelvic Floor Organ function (PFDI-20 score) [Срок оценки: From enrollment til the follow-up visit 12 months postoperatively]
- Change in sexual function and urinary incontinence (PISQ-12 score). [Срок оценки: From the enrollment til follow-up visit at 12 months postoperatively]
- Change in quality of life. (15D questionnaire score) [Срок оценки: From the enrollment til follow-up visit at 12 months postoperatively]
- Change in pelvic pain (VAS score) [Срок оценки: From the enrollment til follow-up visit at 12 months postoperatively]
- Post voiding residual in ml. [Срок оценки: From enrollment til the follow-up visit 12 months postoperatively]
- Duration of surgery in minutes [Срок оценки: From the beginning of surgery til the end of surgery]
- Estimated blood loss in ml [Срок оценки: From the beginning of surgery til the end of surgery.]
- Surgical Complications according to Clavien-Dindo classification. [Срок оценки: From the beginning of surgery til 30 days postoperatively]
- Hospitalisation duration in days [Срок оценки: From the hospitalisation for surgery til discharge home.]
- Anatomical correction of prolapse according POP-Q classification [Срок оценки: Right before the operaton til follow-up visit at 12 months postoperatively]
- Global impression of improvement. (PGI-I questionnaire) [Срок оценки: At follow-up visit 12 months postoperatively]
- Re-operation rate due to recurrence of vaginal apical prolapse, cystocele or rectocele. [Срок оценки: From the end of surgery til follow-up visit at 12 months postoperatively]
Критерии участия
Критерии включения
- Symptomatic pelvic organ prolapse
- Uterine or vaginal vault prolapse reaching the hymenal ring (POP-Q classification: ≥0 cm)
- If uterus in situ, consent for supracervical hysterectomy
- Suitable for laparoscopic mesh surgery
- Age: 18-79 years
- Non-pregnant, no pregnancy desire.
- Sufficient Finnish language skills
- Concurrent anterior and/or posterior prolapse repair if POP-Q criteria met: tvl >8 cm and Aa, Ba, Ap, Bp ≥0
Критерии исключения
- Unwillingness to undergo surgery or mesh implantation
- High anesthetic or surgical risk due to comorbidities
- Indication for laparoscopic sacrocolporectopexy due to rectal intussusception
- Desire to preserve the uterus
- Pregnancy or planning future pregnancy
- Inability to understand Finnish or study-related forms due to cognitive impairments
- Need for concomitant urinary incontinence surgery
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Финляндия · 1 центр
- The Wellbeing Services County of South Ostrobothnia — Seinäjoki
Идентификаторы
NCT: NCT06902909 · R23076