Surgical Repair of Vaginal Wall Prolapse Using Gamma Irradiated Amniotic Membrane as a Scaffold
Condition: Vaginal Wall Prolapse
MeSH terms: Uterine Prolapse; Prolapse
Study type: Interventional

Summary: 
      The surgical repair of vaginal wall prolapse continues to remain one of the most difficult
      challenges in female pelvic floor reconstruction. The recurrence rate after standard
      colporrhaphy ranges from 40-60 %. This high recurrence rate creates the necessity for
      developing new surgical techniques and better long-term solutions. Surgeons have been
      investigating the use of synthetic and biological grafts in vaginal wall prolapse repairs
    

Detailed description: 
      The surgical repair of vaginal wall prolapse continues to remain one of the most difficult
      challenges in female pelvic floor reconstruction. The recurrence rate after standard
      colporrhaphy ranges from 40-60 %. This high recurrence rate creates the necessity for
      developing new surgical techniques and better long-term solutions. Surgeons have been
      investigating the use of synthetic and biological grafts in vaginal wall prolapse repairs.
      The use of an absorbable polyglactin 910 mesh (Vicryl) has shown little benefit in its use to
      correct vaginal wall prolapse (42%), and the use of a synthetic permanent polypropylene mesh
      for vaginal repair shows a mesh erosion rate of 18%, de novo urgency rate of 20%, and
      dyspareunia 22% postoperatively. The mesh erosion rate or infection rate increased four-fold
      when the mesh was introduced vaginally as compared to the abdominal route in pelvic floor
      reconstruction cases.

      Many pelvic surgeons are now using biological grafts for vaginal prolapse surgery, such as
      cadaveric fascia lata, cadaveric dermis, porcine small intestine, porcine dermis, or bovine
      pericardium, which are not used in the Middle East for cultural reasons. A new skin
      tissue-generated matrix has given some hope but is expensive. The use of Amniotic Membrane
      came to our attention as a possible biological graft material, since it is non-immunogenic,
      it will not be rejected, and as of protein nature, will be integrated and absorbed by the
      body after attracting fibrin and collagen, giving necessary support.

      Human amniotic membrane is a tough membrane derived from the fetal membranes. Human amniotic
      membrane is believed to be non-immunogenic, Antibodies or cell-mediated immune response to
      the amniotic membrane have not been demonstrated, suggesting low antigenicity and hence the
      recipient will not reject it. Therefore, the use of systemic immunosuppressive drugs is not
      required.

      Some surgeons have described the use of fresh human amniotic membrane for transplantation,
      but it is not without the risk of infection.

      Another important aspect that makes human amniotic epithelial cells (hAECs) and fetal
      membrane-derived stromal cells attractive for potential stem cell-based therapies is their
      low antigenicity. The hAECs also release several anti-inflammatory factors that lead to a
      significant reduction in HLA class II antigen-presenting cells found at sites of injury that
      prevent apoptosis, enhance wound healing and host cell proliferation, and suppress
      profibrotic transforming growth factor-beta isoforms and type II transforming growth
      factor-beta receptors in myofibroblast cells that deposit collagen, which leads to fibrosis.
      Amniotic membrane has diverse properties against bacterial and viral infections, stores
      antibiotics, and releases them over the course of a few days, and recently has been shown to
      produce potent natural antimicrobials. Clinical studies suggest that the amniotic membrane as
      a biologic dressing has 2 primary favorable effects in addition to being an anatomical
      barrier as it facilitates epithelialization by acting as a basement membrane substrate,
      facilitates migration of epithelial cells, reinforces adhesion of the basal epithelium,
      promotes cellular differentiation, and prevents cellular apoptosis, and it inhibits
      inflammation and fibrosis. Amnion graft, either fresh or dried, is a promising adjunctive
      procedure for decreasing the recurrence of adhesions and encouraging endometrial
      regeneration. Both grafts seem to be equally effective; however, dried amnion graft holds
      some advantages easy availability, prevention of cross-infection, and easier surgical
      application. The use of non sterilized amniotic membrane is supposed to increase the risk of
      fungal, bacterial, or viral diseases transmission from donors. The amniotic membrane graft is
      a natural human protein, attracting collagen formation, fibrinogen, and causing mild
      fibrosis, without being rejected, it will adhere to, and integrate with the local
      pubo-cervical fascia providing a fibrotic sheath, necessary for supporting and augmentation
      of the weak local fascia, and will be completely absorbed by the body
    

Intervention name(s): Vaginal Repair
Intervention type(s): Procedure
Intervention description(s): Vaginal Repair will be done either by application of sterilized (gamma irradiated) amniotic membrane or by Classical repair
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: compare between the usage of Gamma irradiated sterilized amniotic membrane as a graft versus conventional classical repair in terms of: Effectiveness, symptoms relief, healing, and infection rate.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment