Ignite Creation Date:
2024-07-17 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06494982
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-03-25
Brief Title:
The Influence of Using Vascularized Vaginal Flap on the Efficacy of Mesh-augmented Sacrospinous Hysteropexy
Sponsor:
Saint Petersburg State University Russia
Organization:
Saint Petersburg State University Russia
Study Overview
Official Title:
The Influence of Augmentation of the Anterior Vaginal Wall With a Vascularized Flap on the Effectiveness of Mesh-augmented Sacrospinous Hysteropexy and Anterior Subfascial Colporrhaphy During Reconstruction of the Pelvic Floor for POP
Status:
RECRUITING
Status Verified Date:
2024-07
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 is a prospective randomized controlled trial designed to compare the effectiveness and safety of two methods of pelvic floor reconstruction in patients with pelvic organ prolapse POP sacrospinous hysteropexy SSHP with synthetic mesh vascularized anterior vaginal wall flap anterior colporrhaphy and sacrospinous hysteropexy with synthetic mesh anterior colporrhaphy as well as the impact of surgery on quality of life
Detailed Description:
BACKGROUND POP is an epidemiologically widespread condition occurring in 40-60 of women who have given birth With all the variety of anatomical defects of the pelvic floor the most common variant is prolapse of the anterior vaginal wall cystocele
Of the currently known surgical methods for the treatment of cystocele anterior colporrhaphy occupies one of the most key places However the high recurrence rate of 7-23 and according to some authors more than 90 has led to the development of new techniques In 1997 M Cosson proposed the Plastron method the essence of which is to close the defect of the pubocervical fascia by fixing a de-epithelialized flap of the anterior vaginal wall to the tendinous arch of the pelvic fascia and then performing anterior colporrhaphy over it The method was effective in 935 of cases in patients with cystocele At the same time apical prolapse is present in many women with cystocele Apical support is important in maintaining normal pelvic floor anatomy Patients who undergo anterior vaginal wall repair with concomitant repair of the apical defect have a lower risk of reoperation for POP
There are various methods for restoring apical defects while preserving the uterus SSHP is the most studied method and was originally performed using sutures The use of transvaginal mesh for SSHP remains controversial due to the high risk of mesh-associated complications although many authors report the safety and high effectiveness of the SSHP method using transvaginal mesh Despite this the issue of cystocele recurrence after SSHP with or without mesh in combination with anterior colporrhaphy remains unresolved
PREOPERATIVE ASSESSMENT All patients who meet eligibility criteria will undergo a preoperative assessment medical history physical and vaginal examination assessing pelvic organ prolapse according to Pelvic Organ Prolapse Quantification System POP-Q All patients will complete questionnaires validated in Russia Pelvic Floor Disability Index PFDI-20 Pelvic Organ ProlapseUrinary Incontinence Sexual Questionnaire short form PISQ-SF Patient Global Impression of Improvement PGI-I
MATERIALS AND METHODS The investigators hypothesis is that is that the use of a deepithelialized vascularized flap of the anterior vaginal wall when performing mesh-augmented sacrospinous hysteropexy and anterior subfascial colporrhaphy reduces the risks of developing relapses of POP in the anterior compartment
The sample size was calculated taking into account the reported rate of cystocele recurrence using each technique in the literature 65 for sacrospinous hysteropexy using vaginal flap vs 387 for mesh-augmented sacrospinous hysteropexy using subfascial colporrhaphy With a power of 80 a level of 005 and the non-inferiority margin at 15 the sample size is 50 patients The investigators assume a drop-out rate of 20 thus a total of 60 participants will be included in the study
All enrolled patients will be randomly assigned to SSHP using mesh vaginal flap and anterior colporrhaphy or SSHP using mesh and anterior colporrhaphy treatment groups in equal ratio the day before the surgery using computer randomization
All data will be collected by medical staff not involved in treatment Collected pre- and postoperative data will be anonymized using unique codes that patients will receive immediately after randomization
All surgical interventions will be performed by 3 qualified surgeons Postoperative follow-up will be performed 6 and 12 months after surgery by 2 researchers who will be blinded about the type of intervention
Of the currently known surgical methods for the treatment of cystocele anterior colporrhaphy occupies one of the most key places However the high recurrence rate of 7-23 and according to some authors more than 90 has led to the development of new techniques In 1997 M Cosson proposed the Plastron method the essence of which is to close the defect of the pubocervical fascia by fixing a de-epithelialized flap of the anterior vaginal wall to the tendinous arch of the pelvic fascia and then performing anterior colporrhaphy over it The method was effective in 935 of cases in patients with cystocele At the same time apical prolapse is present in many women with cystocele Apical support is important in maintaining normal pelvic floor anatomy Patients who undergo anterior vaginal wall repair with concomitant repair of the apical defect have a lower risk of reoperation for POP
There are various methods for restoring apical defects while preserving the uterus SSHP is the most studied method and was originally performed using sutures The use of transvaginal mesh for SSHP remains controversial due to the high risk of mesh-associated complications although many authors report the safety and high effectiveness of the SSHP method using transvaginal mesh Despite this the issue of cystocele recurrence after SSHP with or without mesh in combination with anterior colporrhaphy remains unresolved
PREOPERATIVE ASSESSMENT All patients who meet eligibility criteria will undergo a preoperative assessment medical history physical and vaginal examination assessing pelvic organ prolapse according to Pelvic Organ Prolapse Quantification System POP-Q All patients will complete questionnaires validated in Russia Pelvic Floor Disability Index PFDI-20 Pelvic Organ ProlapseUrinary Incontinence Sexual Questionnaire short form PISQ-SF Patient Global Impression of Improvement PGI-I
MATERIALS AND METHODS The investigators hypothesis is that is that the use of a deepithelialized vascularized flap of the anterior vaginal wall when performing mesh-augmented sacrospinous hysteropexy and anterior subfascial colporrhaphy reduces the risks of developing relapses of POP in the anterior compartment
The sample size was calculated taking into account the reported rate of cystocele recurrence using each technique in the literature 65 for sacrospinous hysteropexy using vaginal flap vs 387 for mesh-augmented sacrospinous hysteropexy using subfascial colporrhaphy With a power of 80 a level of 005 and the non-inferiority margin at 15 the sample size is 50 patients The investigators assume a drop-out rate of 20 thus a total of 60 participants will be included in the study
All enrolled patients will be randomly assigned to SSHP using mesh vaginal flap and anterior colporrhaphy or SSHP using mesh and anterior colporrhaphy treatment groups in equal ratio the day before the surgery using computer randomization
All data will be collected by medical staff not involved in treatment Collected pre- and postoperative data will be anonymized using unique codes that patients will receive immediately after randomization
All surgical interventions will be performed by 3 qualified surgeons Postoperative follow-up will be performed 6 and 12 months after surgery by 2 researchers who will be blinded about the type of intervention
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