跳至主要内容
临床试验/NCT05876975
NCT05876975招募中不适用

Vaginal Axis on MRI After Laparoscopic Pectopexy Surgery: a Controlled Study

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2023年1月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
21
试验地点
1
主要终点
Anatomic Success

研究概览

简要总结

Pelvic organ prolapse (POP) is a major public health concern that adversely affects the physical and psychological well-being of women. In fact, the lifetime risk of POP surgery is 12.6%, highlighting the magnitude of the problem. The most common form of POP involves defects in the anterior vaginal wall accompanied by apical prolapse. The primary objective of surgical treatment for POP is to mitigate symptoms and restore the pelvic support anatomy. Normally, the vaginal axis is directed posteriorly towards the S3 and S4 vertebrae, lying relatively horizontally to the levator plate, and forming an angle of about 130º between the middle and lower vagina. Although sacrocolpopexy (SCP) is considered the gold standard for treating POP, it alters the normal anatomical position of the vaginal axis towards the sacral promontory, which may increase the abdominal pressure load on the anterior wall and cause urge symptoms or de novo anterior compartment prolapse. Similarly, sacrospinous ligament fixation (SSLF) increases the risk of anterior vaginal wall prolapse, as it deviates the vaginal axis towards the posterior. However, laparoscopic lateral mesh suspension has recently become popular because it preserves the normal position of the vaginal axis, preventing such complications. A previous study found that the pectineal ligament (Cooper's ligament) is composed of stronger and more durable tissue than the sacrospinous ligament and arcus tendineus of the fascia pelvis. This structure is robust and can hold sutures well, and it is possible to find sufficient material for a suture in the lateral part of the iliopectineal ligament, facilitating pelvic floor reconstruction. This segment of the ligament is located at the second sacral vertebra (S2) level, which is the optimal level for the physiological axis of the vagina. S2 level serves as the anchor point for the physiological axis of the vagina. Further studies have demonstrated that laparoscopic pectopexy provides outcomes comparable to those of laparoscopic sacrocolpopexy for supporting the apical compartment during intermediate follow-up duration. The current study aimed to investigate the level of anatomical correction following laparoscopic pectopexy and compare the vaginal axis of patients with apical genital prolapse to that of nulliparous women using magnetic resonance imaging (MRI).

详细描述

Pelvic organ prolapse (POP) is a significant health concern that has a negative impact on the physical and psychological well-being of women. In fact, the lifetime risk of undergoing POP surgery is 12.6%. The most common form of POP involves defects in the anterior vaginal wall accompanied by apical prolapse. The primary goal of surgical treatment for POP is to alleviate symptoms and restore the anatomy of the pelvic support. The normal position of the vaginal axis is directed posteriorly towards the S3 and S4 vertebrae, lying relatively horizontally to the levator plate, and forming an angle of about 130º between the middle and lower vagina. Sacrocolpopexy (SCP) is considered the gold standard for treating POP, but it alters the normal anatomical position of the vaginal axis towards the sacral promontory, which may increase the abdominal pressure load on the anterior wall and cause urge symptoms or de novo anterior compartment prolapse. Although sacrospinous ligament fixation (SSLF) has promising long-term outcomes for correcting the apical anatomy, it increases the risk of anterior vaginal wall prolapse, like SCP, due to the deviation of the vaginal axis towards the posterior. Recently, laparoscopic lateral mesh suspension, which keeps the vaginal axis close to normal, has become popular. In a previous study, it was found that the pectineal ligament (Cooper's ligament) is composed of stronger and more durable tissue than the sacrospinous ligament and arcus tendineus of the fascia pelvis. This structure is robust and can hold sutures well. Sufficient material for a suture can also be found in the lateral part of the iliopectineal ligament, making pelvic floor reconstruction easier. This segment of the ligament is located at the second sacral vertebra (S2) level, which is the optimal level for the physiological axis of the vagina. S2 level is the anchor point for the physiological axis of the vagina. Further studies have demonstrated comparable outcomes for supporting the apical compartment at intermediate follow-up duration compared to laparoscopic sacrocolpopexy. This study aimed to investigate the level of anatomical correction following Laparoscopic pectopexy and compare the vaginal axis of patients with apical genital prolapse to that of nulliparous women using magnetic resonance imaging (MRI).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •In Intervention Group
  • •Inclusion Criteria:
  • •Women diagnosed with apical pelvic organ prolapse (POP), who did not require an additional posterior colporrhaphy procedure, and desired to undergo uterus-preserving surgery were scheduled for laparoscopic pectopexy.

排除标准

  • •Women with uterine size greater than 10 cm or a pelvic mass that may alter or interfere with accurate measurement.
  • •Women with any congenital or acquired anatomical or reproductive anomaly.
  • •Women diagnosed with enterocele through transperineal ultrasound prior to enrollment.
  • •Women who require hysterectomy or concomitant pelvic organ prolapse (POP) or anti- incontinence procedure.
  • •Women with abnormal uterine bleeding.
  • •Women with abnormal cervical screening test results.
  • •In Control Group
  • •Inclusion Criteria:
  • •Nulliparous women without pelvic organ prolapse (asymptomatic grade 1 or less) who presented to the outpatient clinic with complaints other than POP symptoms (e.g., menstrual irregularity) were randomly selected and assigned as the control group.
  • •Exclusion Criteria:
  • •Women who have given birth previously.
  • •Women with a history of pelvic organ prolapse or any pelvic floor disorders.
  • •Women who have undergone pelvic surgery.
  • •Women with any congenital or acquired anatomical or reproductive anomaly.
  • •Women with abnormal uterine bleeding.
  • •Women with abnormal cervical screening test results.

研究组 & 干预措施

procedure: laparoscopic pectopexy

Active Comparator

MRI evaluation will be conducted on eleven participants who underwent laparoscopic pectopexy surgery after one month.

干预措施: laparoscopic pectopexy (Procedure)

Nulliparous women with no uterovaginal prolapsed

No Intervention

Ten nulliparous participants with no uterovaginal prolapsed will be evaluate by MRI

结局指标

主要结局

Anatomic Success

时间窗: 3 months

anatomic success will be evaluated by using magnetic resonance imaging. Vaginal axis (distance to spin ischiadic a and sacrum) will be measure on three plane

次要结局

  • Urge Symptoms stres incontinence(3 month)
  • Sexual functions(3 month)

研究者

发起方
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
申办方类型
Other
责任方
Principal Investigator
主要研究者

fatih sahin

MD / Principal Investigator

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

研究点 (1)

Loading locations...

相似试验