Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06369857
Status:
RECRUITING
Last Update Posted:
2024-05-10
First Post:
2024-03-24
Brief Title:
Pectopexy for Apical Prolapse Management
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Pectopexy for Treatment of Apical Pelvic Organ Prolapse
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study was designed to evaluate the efficacy of pectopexy for treatment of apical pelvic organ prolapse at follow up at 12 months Investigator also evaluates complications improvement of symptoms quality-of-life outcomes and patient satisfaction with surgery
Assessment of restoration of normal pelvic anatomy and lower urinary tract symptoms using transperineal ultrasound
Assessment of restoration of normal pelvic anatomy and lower urinary tract symptoms using transperineal ultrasound
Detailed Description:
Pelvic organ prolapse POP substantially affects the quality of life QOL of women with a global prevalence of 20 to 65 Surgery is the major treatment option for patients with POP at POP Quantification POP-Q stage II especially after failure of conservative treatments Apical pelvic organ prolapse is a common issue in Egypt with significant incidence rate due to many predisposing factors including increasing age higher gravidity and parity especially the number of vaginal births
Apical support is the most important factor for the successful outcome of pelvic reconstruction surgery Apical suspension can be performed transabdominally or transvaginally using native tissue or a synthetic mesh Abdominal sacropexy is considered now the gold standard operation for treatment of apical pelvic organ prolapse However many intraoperative complication can occur including hemorrhage or transfusion or both occurred in 44 intestinal injury or rectal injury in 16 04 to 25and ureteral injury in 10 of cases Postoperative complications include paralytic ileus in 36transient femoral nerve injury and vertebral osteomyelitis Sacropexy also has a long steep learning curve
Pectopexy has been in 2011 where synthetic mesh is fixed to the pectineal ligaments bilaterallyThis surgery is presumed to have fewer complications because the surgical field is limited to the anterior pelvis with a decreased risk of injury to the adjacent organs The technique is suitable for surgeons seeking an attractive alternative for patients in a context of high morbidity andor with difficult access to the promontory However adequate evidence to support this surgical option still needs further studies
Apical support is the most important factor for the successful outcome of pelvic reconstruction surgery Apical suspension can be performed transabdominally or transvaginally using native tissue or a synthetic mesh Abdominal sacropexy is considered now the gold standard operation for treatment of apical pelvic organ prolapse However many intraoperative complication can occur including hemorrhage or transfusion or both occurred in 44 intestinal injury or rectal injury in 16 04 to 25and ureteral injury in 10 of cases Postoperative complications include paralytic ileus in 36transient femoral nerve injury and vertebral osteomyelitis Sacropexy also has a long steep learning curve
Pectopexy has been in 2011 where synthetic mesh is fixed to the pectineal ligaments bilaterallyThis surgery is presumed to have fewer complications because the surgical field is limited to the anterior pelvis with a decreased risk of injury to the adjacent organs The technique is suitable for surgeons seeking an attractive alternative for patients in a context of high morbidity andor with difficult access to the promontory However adequate evidence to support this surgical option still needs further studies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None