Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06404931
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-03-08
Brief Title:
Transvaginal Human Acellular Dermal Matrix for Prolapse Treatment
Sponsor:
Hospital Mutua de Terrassa
Organization:
Hospital Mutua de Terrassa
Study Overview
Official Title:
Transvaginal Human Acellular Dermal Matrix and Sacrospinous Fixation for Anterior and Apical Prolapse Treatment in Patients With Hiatal Ballooning or Levator Ani Injury a Randomized Pilot Trial
Status:
NOT_YET_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 is a randomised study in which we compare the effectiveness of three different procedures in mending symptomatic anterior and apical prolapse in patients who are candidates to receive surgery
They will be randomly assigned in a ratio 111 to three different groups who will have assigned three different kinds of surgery In the patients of the first group a classic vaginal hysterectomy with anterior colporrhaphy will be practised Patients who belong to group two will undergo a vaginal hysterectomy followed by placement of an acellular dermal matrix from cadaveric donors hADM for anterior reinforcement and sacrospinous fixation with Anchorsure device Neomedic trade mark TM International Spain Finally patients from group three will have vaginal hysterectomy followed by sacrospinous fixation with Anchorsure alone
Patients will be followed-up at 4 weeks 6 months 12 months and annually till 36 months to evaluate relapses and possible complications
They will be randomly assigned in a ratio 111 to three different groups who will have assigned three different kinds of surgery In the patients of the first group a classic vaginal hysterectomy with anterior colporrhaphy will be practised Patients who belong to group two will undergo a vaginal hysterectomy followed by placement of an acellular dermal matrix from cadaveric donors hADM for anterior reinforcement and sacrospinous fixation with Anchorsure device Neomedic trade mark TM International Spain Finally patients from group three will have vaginal hysterectomy followed by sacrospinous fixation with Anchorsure alone
Patients will be followed-up at 4 weeks 6 months 12 months and annually till 36 months to evaluate relapses and possible complications
Detailed Description:
Eligible patients will be women with symptomatic anterior and apical prolapse with hiatal ballooning or levator ani injury eligible for vaginal surgical treatment
At the time of the indication for surgery anatomical severity of the prolapse according to the Pelvic Organ Prolapse Quantification System POP-Q scale and the symptoms of prolapse and sexual function as well as their impact on the quality of life of the patient are evaluated using validated questionnaires Pelvic Floor Impact Questionnaire PFIQ Pelvic organ ProlapseUrinary Incontinence Sexual Questionnaire PISQ-12and European Quality of Life-5 Dimensions Questionnaire EQ5D Anatomical severity of the prolapse will be also evaluated by ecography described as follows
Three-dimensional 3D4D transperineal ultrasound TPS will be performed using a GE Voluson ultrasound system GE Medical Systems with a RAB 8-4-MHz transducer at an acquisition angle of 85
TPS will be performed with the probe covered with a powder-free glove and applied in the midsagittal plane to the introitus using moderate pressure Volumes are acquired at rest on maximum pelvic floor muscle contractility and during maximal Valsalva maneuver Patients perform Valsalva for at least 5 s and the best of three volumes is used for analysis Using visual biofeedback an attempt is made to correct for levator co-activation by requesting the women observe the narrowing and widening of the levator hiatus during the maneuvers
3D volumes are measured offline using GE 4 Dimension View GE Medical Systems Using the best Valsalva maneuver pelvic organ descent measurements are obtained relative to a horizontal line from the inferior margin of the pubic symphysis Levator hiatal area is assessed in the plane of minimal hiatal dimensions
Surgical indication will be determined by gynaecologists and the decision will be clearly dissociated from the decision of study inclusion Therefore the performance of the study should not modify the habits of surgical indication by the doctors
The study will be a single-blinded study as it is impossible to blind the health care workers involved for the surgical procedure to which the woman is randomized The physician evaluating the patients during the follow-up will be blinded about the group the patients were randomized to
Women will be randomly assigned after consenting for participation in the study by means of an interactive response technology system in a 111 ratio to receive surgical treatment with vaginal hysterectomy followed by hADM anterior reinforcement and sacrospinous fixation with Anchorsure device NeomedicTM International Spain vaginal hysterectomy followed by sacrospinous fixation with Anchorsure alone or classic vaginal hysterectomy with anterior colporrhaphy A sacrospinous fixation-alone group was included to assess the impact of this technique in the principal surgery group Patients will be followed-up at 4 weeks 6 months 12 months and annually till 36 months
Anatomical results will be evaluated by a member of the team blinded to the surgery performed during follow-up visits after surgery and by 3D ultrasound of the pelvic floor Functional results are evaluated using the validated questionnaires performed prior to surgery done by the patients during follow-up visits after surgery
At the time of the indication for surgery anatomical severity of the prolapse according to the Pelvic Organ Prolapse Quantification System POP-Q scale and the symptoms of prolapse and sexual function as well as their impact on the quality of life of the patient are evaluated using validated questionnaires Pelvic Floor Impact Questionnaire PFIQ Pelvic organ ProlapseUrinary Incontinence Sexual Questionnaire PISQ-12and European Quality of Life-5 Dimensions Questionnaire EQ5D Anatomical severity of the prolapse will be also evaluated by ecography described as follows
Three-dimensional 3D4D transperineal ultrasound TPS will be performed using a GE Voluson ultrasound system GE Medical Systems with a RAB 8-4-MHz transducer at an acquisition angle of 85
TPS will be performed with the probe covered with a powder-free glove and applied in the midsagittal plane to the introitus using moderate pressure Volumes are acquired at rest on maximum pelvic floor muscle contractility and during maximal Valsalva maneuver Patients perform Valsalva for at least 5 s and the best of three volumes is used for analysis Using visual biofeedback an attempt is made to correct for levator co-activation by requesting the women observe the narrowing and widening of the levator hiatus during the maneuvers
3D volumes are measured offline using GE 4 Dimension View GE Medical Systems Using the best Valsalva maneuver pelvic organ descent measurements are obtained relative to a horizontal line from the inferior margin of the pubic symphysis Levator hiatal area is assessed in the plane of minimal hiatal dimensions
Surgical indication will be determined by gynaecologists and the decision will be clearly dissociated from the decision of study inclusion Therefore the performance of the study should not modify the habits of surgical indication by the doctors
The study will be a single-blinded study as it is impossible to blind the health care workers involved for the surgical procedure to which the woman is randomized The physician evaluating the patients during the follow-up will be blinded about the group the patients were randomized to
Women will be randomly assigned after consenting for participation in the study by means of an interactive response technology system in a 111 ratio to receive surgical treatment with vaginal hysterectomy followed by hADM anterior reinforcement and sacrospinous fixation with Anchorsure device NeomedicTM International Spain vaginal hysterectomy followed by sacrospinous fixation with Anchorsure alone or classic vaginal hysterectomy with anterior colporrhaphy A sacrospinous fixation-alone group was included to assess the impact of this technique in the principal surgery group Patients will be followed-up at 4 weeks 6 months 12 months and annually till 36 months
Anatomical results will be evaluated by a member of the team blinded to the surgery performed during follow-up visits after surgery and by 3D ultrasound of the pelvic floor Functional results are evaluated using the validated questionnaires performed prior to surgery done by the patients during follow-up visits after surgery
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