Transvaginal Human Acellular Dermal Matrix for Prolapse Treatment

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

Overview

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 1:1:1 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 Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)"and "European Quality of Life-5 Dimensions Questionnaire (EQ5D)". Anatomical severity of the prolapse will be also evaluated by ecography described as follows.

Three-dimensional 3D/4D 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 1:1:1 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.

Interventions

• Procedure Vaginal hysterectomy plus matrix reinforcement and sacrospinous fixation with Anchorsure® device
  Vaginal hysterectomy plus matrix reinforcement and sacrospinous fixation with Anchorsure® device
• Procedure Vaginal hysterectomy plus anterior colporrhaphy
  Vaginal hysterectomy plus anterior colporrhaphy
• Procedure Vaginal hysterectomy plus sacrospinous fixation with Anchorsure® device
  Vaginal hysterectomy plus sacrospinous fixation with Anchorsure® device

Primary outcome measures

• Recurrence of anatomical anterior vaginal wall prolapse [Time frame: 36 months]

Secondary outcome measures (8)

• Difference between groups in anatomical prolapse [Time frame: 36 moths]
• Differences between groups in symptomatic recurrence [Time frame: 36 months]
• Differences between groups in quality of Life [Time frame: 36 months]
• Differences between groups in sexual functioning. [Time frame: 36 months]
• Differences between groups in hospital stay [Time frame: 36 months]
• Differences between groups in operative time [Time frame: 36 months]
• Differences between groups in surgical complication rate. [Time frame: 36 months]
• Differences between groups in reintervention rate [Time frame: 36 months]

Eligibility criteria

Inclusion criteria

• Women with symptomatic POP with indication of vaginal surgery.
• Women with hiatal ballooning or levator ani injury evaluated by 3D pelvic floor ultrasound.
• Women ≥18 years old.
• Women wishing to complete a 36-month follow-up.
• Understand and accept the study procedures and sign the informed consent.

Exclusion criteria

• Women with previous pelvic floor or prolapse surgery
• Women with POP grade IV
• Women with chronic pelvic pain.
• Not being able to understand the nature of the study and/or the procedures to be followed.
• Not signing the informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Spain · 1 center

• Hospital Mutua de Terrassa — Terrassa

Publications

• Flynn BJ, Webster GD. Surgical management of the apical vaginal defect. Curr Opin Urol. 2002 Jul;12(4):353-8. doi: 10.1097/00042307-200207000-00015. PMID 12072658
• Unger CA, Barber MD. Vaginal Mesh in Pelvic Reconstructive Surgery: Controversies, Current Use, and Complications. Clin Obstet Gynecol. 2015 Dec;58(4):740-53. doi: 10.1097/GRF.0000000000000148. PMID 26512439
• NHS Improvement, NHS England. Letter to Acute Trust CEOs and Medical Directors. 2018;(July 2017). Available from: www.england.nhs.uk
• Salzberg CA. Nonexpansive immediate breast reconstruction using human acellular tissue matrix graft (AlloDerm). Ann Plast Surg. 2006 Jul;57(1):1-5. doi: 10.1097/01.sap.0000214873.13102.9f. PMID 16799299
• Guo X, Mu D, Gao F. Efficacy and safety of acellular dermal matrix in diabetic foot ulcer treatment: A systematic review and meta-analysis. Int J Surg. 2017 Apr;40:1-7. doi: 10.1016/j.ijsu.2017.02.008. Epub 2017 Feb 14. PMID 28232031
• Menon NG, Rodriguez ED, Byrnes CK, Girotto JA, Goldberg NH, Silverman RP. Revascularization of human acellular dermis in full-thickness abdominal wall reconstruction in the rabbit model. Ann Plast Surg. 2003 May;50(5):523-7. doi: 10.1097/01.SAP.0000044252.76804.6B. PMID 12792544
• Salzberg CA, Ashikari AY, Koch RM, Chabner-Thompson E. An 8-year experience of direct-to-implant immediate breast reconstruction using human acellular dermal matrix (AlloDerm). Plast Reconstr Surg. 2011 Feb;127(2):514-524. doi: 10.1097/PRS.0b013e318200a961. PMID 21285756
• Griffey S, Schwade ND, Wright CG. Particulate dermal matrix as an injectable soft tissue replacement material. J Biomed Mater Res. 2001;58(1):10-5. doi: 10.1002/1097-4636(2001)58:13.0.co;2-e. PMID 11152992

Identifiers

NCT: NCT06404931 · Mesh in prolapse treatment

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗