Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2025-12-30 @ 11:45 PM
Study NCT ID:
NCT07080957
Status:
COMPLETED
Last Update Posted:
2025-08-05
First Post:
2025-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Mesh-Based and Mesh-Free Laparoscopic Pectopexy in Uterus-Preserving Surgery for Apical Prolapse
Sponsor:
Havva Betül Bacak
Organization:
Study Overview
Official Title:
Comparative Outcomes of Mesh-Based and Mesh-Free Laparoscopic Uterus-Preserving Pectopexy for Apical Prolapse: A Retrospective Cohort Study
Status:
COMPLETED
Status Verified Date:
2025-08
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:
PectoMesh
Brief Summary:
This retrospective cohort study compares anatomical and functional outcomes of mesh-based and mesh-free laparoscopic uterus-preserving pectopexy in women with apical pelvic organ prolapse. A total of 81 patients were included between 2021 and 2024 (mesh-based: 41, mesh-free: 40). Key outcomes assessed included operative time, blood loss, hospital stay, anatomical correction (POP-Q), sexual function (PISQ-12), and complications. Both techniques significantly improved prolapse and sexual function. Mesh-based pectopexy offered superior apical and posterior support, while mesh-free pectopexy was associated with longer vaginal length and longer operative time. Complication and recurrence rates were low and similar across groups. The findings suggest that both techniques are effective, and surgical approach should be tailored to patient preference and clinical context.
Detailed Description:
This retrospective cohort study was conducted to compare the anatomical and functional outcomes of mesh-based and mesh-free laparoscopic uterus-preserving pectopexy in the treatment of apical pelvic organ prolapse (POP). POP is a common condition among women, particularly those over 50 years of age, characterized by the descent of pelvic organs into the vaginal canal. While mesh-based procedures are known to offer robust apical support, they are associated with long-term complications such as mesh erosion, infection, and chronic pelvic pain. In contrast, mesh-free techniques may offer a safer alternative, particularly for patients wishing to avoid synthetic implants.
A total of 81 patients who underwent laparoscopic pectopexy between 2021 and 2024 at a tertiary care institution were included. Patients were divided into two groups based on the use of mesh: 41 underwent mesh-based and 40 underwent mesh-free procedures. Preoperative and postoperative assessments were conducted using the POP-Q (Pelvic Organ Prolapse Quantification) system for anatomical staging and the PISQ-12 (Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire) for evaluating sexual function. Operative time, estimated blood loss, length of hospital stay, postoperative complications, and recurrence rates were also analyzed. Follow-up evaluations were scheduled at 6 weeks, 3 months, and 1 year.
The study found that both techniques significantly improved anatomical support and sexual function. Mesh-based pectopexy provided better apical and posterior compartment support, while the mesh-free approach resulted in a longer vaginal length and was preferred by patients seeking to avoid mesh-related complications. Operative time was significantly longer in the mesh-free group. Complication and recurrence rates were low and comparable between groups.
This study contributes to the growing body of evidence supporting uterus-preserving surgical options in POP treatment and highlights the importance of individualized surgical planning based on patient needs, preferences, and clinical profiles.
A total of 81 patients who underwent laparoscopic pectopexy between 2021 and 2024 at a tertiary care institution were included. Patients were divided into two groups based on the use of mesh: 41 underwent mesh-based and 40 underwent mesh-free procedures. Preoperative and postoperative assessments were conducted using the POP-Q (Pelvic Organ Prolapse Quantification) system for anatomical staging and the PISQ-12 (Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire) for evaluating sexual function. Operative time, estimated blood loss, length of hospital stay, postoperative complications, and recurrence rates were also analyzed. Follow-up evaluations were scheduled at 6 weeks, 3 months, and 1 year.
The study found that both techniques significantly improved anatomical support and sexual function. Mesh-based pectopexy provided better apical and posterior compartment support, while the mesh-free approach resulted in a longer vaginal length and was preferred by patients seeking to avoid mesh-related complications. Operative time was significantly longer in the mesh-free group. Complication and recurrence rates were low and comparable between groups.
This study contributes to the growing body of evidence supporting uterus-preserving surgical options in POP treatment and highlights the importance of individualized surgical planning based on patient needs, preferences, and clinical profiles.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: