Clinical Trials Logo

Clinical Trial Summary

This study aims to compare between abdominal pectopexy and abdominal sacral hysteropexy in terms of efficacy (assessed by POP-Q system), intra and postoperative complications.


Clinical Trial Description

Pelvic organ prolapse (POP), the herniation of the pelvic organs to or beyond the vaginal walls, is a common condition. Many women with prolapse experience symptoms that impact daily activities, sexual function, and exercise. The presence of POP can have a detrimental impact on body image and sexuality (Lowder et al., 2011). Nulliparous prolapse is reported to account for 1.5% to 2% of all cases of genital prolapse (Virkud, 2016). The incidence rises to 5 -8 % for young women who have delivered one or two children. As this type of prolapse occurs at a younger age, the surgical technique should not only reduce the prolapse but also retain the reproductive function. Various conservative surgeries have been described in the past, each having their own merits and de-merits (Rameshkumar et al., 2017). Pelvic organ prolapse (POP) is affecting women of all ages. Epidemiological studies suggest a lifetime risk of prolapse or incontinence surgery of between 7 and 19% (Olsen et al., 1997; Smith et al., 2010). In an ageing population, the incidence of these surgeries would only be expected to increase, although the increasing Caesarean Section rates and smaller family size in recent years will have a negative impact on the prevalence of these conditions. There are many approaches to the surgical correction of POP, which frequently reflect the nature and anatomical site of the defective support, but essentially the surgeon has to decide whether to perform this surgery vaginally or via the abdomen as an open or laparoscopic procedure. If performed vaginally, further decisions regarding the use of synthetic or biological graft to reinforce the repair need to be made (Cvach and Dwyer, 2012). Pectopexy is a new technique for apical repair in which lateral parts of the iliopectineal ligament are used for cuff or cervix suspension. This new method is considered a simple, safe procedure, especially in patients whose surgical exploration is difficult (Banerjee and Noé, 2011). This method uses the iliopectineal ligament on both sides for the mesh fixation, (Banerjee and Noé, 2011). so there is no restriction caused by the mesh. The mesh follows natural structures (round and broad ligaments) without crossing sensitive spots, such as the ureter or bowel. The hypogastric trunk is at a safe distance and out of danger. The iliopectineal ligament is an extension of the lacunar ligament that runs on the pectineal line of the pubic bone (Faure et al., 2001), and is significantly stronger than the sacrospinous ligament and the arcus tendineus of the pelvic fascia (Cosson et al., 2003). The structure is strong, and holds suture well Abdominal sacral hysteropexy remains a viable alternative for women undergoing pelvic reconstructive surgery who wish to retain their uteri, providing comparable rates of overall improvement and symptom change. Avoiding hysterectomy decreases the risk of mesh erosion but may increase the risk of subsequent recurrent prolapse, specifically in the anterior compartment (Cvach and Cundiff, 2008). Although sacrocolpopexy has been the most effective option over time, the procedure is still associated with some problems, and the most frequently reported complications include defecation disorders and stress urinary incontinence (SUI) ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04856709
Study type Interventional
Source Ain Shams University
Contact
Status Completed
Phase N/A
Start date June 1, 2019
Completion date April 1, 2021

See also
  Status Clinical Trial Phase
Terminated NCT00784602 - Observing Pelvic Organ Prolapse Symptoms And Treatment Outcomes N/A
Recruiting NCT02050568 - Mechanism of Incontinence Before and After Genital Prolapse Surgery N/A
Completed NCT02585544 - Ambulatory Prolapse Surgery N/A
Not yet recruiting NCT02906111 - Vaginal Estriol Before and Vaginal Surgery for Prolapse Phase 4
Active, not recruiting NCT00771225 - National,Multicentric Randomised Study of the Correction of Genital Prolapse With Fascial Repair or Mesh-Prolift Phase 4
Completed NCT00551551 - Prenatal Pelvic Floor Prevention (3PN) Phase 3
Withdrawn NCT00554944 - Intraoperative Goal-directed Fluid Management N/A
Recruiting NCT03615872 - Pessary Satisfaction Criteria for Urogenital Prolapse
Completed NCT00747370 - Dynamic MRI of the Behaviour of Female Pelvic Floor Phase 0
Completed NCT03901586 - Satisfaction and Long-term Anatomic Efficacy Study on Patients Who Underwent a Richter Intervention in the Obstetric and Gynecology Department of Foch Hospital Since 2008 N/A