Vaginally Assisted Laparoscopic Hysteropexy Versus Vaginal Hysterectomy
Condition: Pelvic Organ Prolapse
MeSH terms: Prolapse; Pelvic Organ Prolapse
Study type: Observational

Summary: 
      Utero-vaginal prolapse is a common, often disabling, condition experienced by women of
      varying ages. The traditional surgical treatment for utero-vaginal prolapse often includes
      vaginal hysterectomy and anterior or posterior colporrhaphy. Growing emphasis on
      patient-centered medicine and patient-generated definitions of surgical success has resulted
      in reassessment of uterine preservation versus hysterectomy at the time of apical POP repair.
      Various techniques have been described for uterine preserving prolapse surgery, which may
      include vaginal sacrospinous hysteropexy, transvaginal mesh kits, abdominal sacrohysteropexy
      using mesh and laparoscopic uterine suspension using sling or mesh. A modified form of
      uterine-preserving prolapse surgery using a combined vaginal and laparoscopic approach was
      introduced and a series of 70 women was reported. To date, there have been no randomized
      studies comparing the outcomes of vaginal assisted laparoscopic uterine suspension
      (hysteropexy) with conventional vaginal hysterectomy. Women attending the gynecology clinic
      at a tertiary referral urogynecology unit in tertiary referral training and research hospital
      requesting surgical treatment for STAGE 2-4 symptomatic uterine prolapse will be offered
      participation in a randomized trial, over a 2-year period. Subjects participating in the
      study were randomly assigned to either of two groups: Group A, Vaginally Assisted
      Laparoscopic Hysteropexy (VALH), or Group B, Vaginal Hysterectomy and Mc Call Culdoplasty (VH
      + Mc Call).1 year following surgery, vaginal prolapse will be assessed again using the
      International Consultation on Incontinence Questionnaire for Vaginal Symptoms (ICIQ-VS)
      questionnaire and the Pelvic Organ Prolapse -Quantification (POP-Q) examination by another
      researcher then the operator.
    

Detailed description: 
      Utero-vaginal prolapse is a common, often disabling, condition experienced by women of
      varying ages. The traditional surgical treatment for utero-vaginal prolapse often includes
      vaginal hysterectomy and anterior or posterior colporrhaphy. Growing emphasis on
      patient-centered medicine and patient-generated definitions of surgical success has resulted
      in reassessment of uterine preservation versus hysterectomy at the time of apical pelvic
      organ prolapse (POP) repair. Comparison of study outcomes between hysteropexy and
      hysterectomy are confounded by anatomic variables (isolated apical prolapse or multiple
      compartment prolapse), hormonal status (premenopausal, postmenopausal on hormone therapy, and
      postmenopausal without hormone therapy), and surgical approach (vaginal, open abdominal,
      laparoscopic, and robotic). In addition, the number of women who subsequently undergo
      hysterectomy after a uterus-sparing prolapse surgery is not known. With the caveat of these
      limitations, new short-term data are available to inform consideration of uterine-sparing POP
      repair. Various techniques have been described for uterine preserving prolapse surgery, which
      may include vaginal sacrospinous hysteropexy, transvaginal mesh kits, abdominal
      sacrohysteropexy using mesh and laparoscopic uterine suspension using sling or mesh. A
      modified form of uterine-preserving prolapse surgery using a combined vaginal and
      laparoscopic approach was introduced and a series of 70 women was reported.To date, there
      have been no randomized studies comparing the outcomes of vaginal assisted laparoscopic
      uterine suspension (hysteropexy) with conventional vaginal hysterectomy.

      This is a single-center, randomized controlled study of two parallel groups. Women attending
      the gynecology clinic at a tertiary referral urogynecology unit requesting surgical treatment
      for STAGE 2-4 symptomatic uterine prolapse will be offered participation in a randomized
      trial, over a 2-year period between February 2018 and February 2020.

      Requirements for women recruited are that

        -  patients who are over 35 years of age with no desire to preserve fertility. (Subjects
           had completed childbearing or were practicing reliable contraception)

        -  have a normal size uterus (<10 cm) on examination or ultrasound

        -  who agree to participate in principle will be given further information about the trial
           and consent will be obtained either in an outpatient clinic or at the next visit for
           preoperative assessment.

      Investigators will exclude women with

        -  cervical elongation (surgeon discretion),

        -  prior mesh prolapse repair,

        -  current foreign-body complications,

        -  increased risk or recent history of cervical dysplasia, chronic pelvic pain, significant
           uterine abnormalities, and abnormal menstruation.

        -  Postmenopausal bleeding in the past 12 months

        -  Women with a significantly enlarged fibroid uterus or concomitant medical problems
           precluding general anesthesia or the use of a steep Trendelenburg position Subjects
           participating in the study will be randomly assigned to either of two groups: Group A,
           Vaginally Assisted Laparoscopic Hysteropexy (VALH), or Group B, Vaginal Hysterectomy and
           Vaginal Vault Suspension (VAH + VVS). Those recruited who subsequently have a strong
           preference or either operation and consequently decline to continue in the study will be
           excluded and will not randomized.

      VALH surgical procedure described below:

      The procedure was performed under general anesthesia with the patient initially in the
      lithotomy position. After insertion of a urinary catheter, a 2 cm transverse vaginal incision
      was performed to the posterior cervix. The vaginal mucosa on the posterior cervix was
      dissected and type 1 polypropylene mesh secured to the posterior cervix with six 2/0
      polydioxanone sutures. After skin preparation, and draping, a pneumoperitoneum was created
      and three laparoscopic ports were placed; 11 mm umbilical, 5 mm left and right lateral ports,
      and 5 mm suprapubic port. The sacral promontory was subsequently visualized and the presacral
      peritoneum was opened with monopolar diathermy and laparoscopic scissors.The tail end of the
      mesh was then push forward to the promontorium in the retroperitoneal region under
      laparoscopic visualisation. The end of the mesh grasped and pulled up laparoscopically. The
      uterus pushed up to the using the uterine manipulator. The mesh was then tacked to the sacral
      promontory with 5 mm helical fasteners. Finally, the mesh was completely covered with
      peritoneum, gas was expelled and ports were withdrawn under vision. Skin incisions were
      closed with absorbable fine sutures.

      On the day of the operation allocation will be confirmed and appropriate consent will be
      obtained for the specific surgical procedure. Vaginal hysterectomy + Mc Call Culdoplasty and
      vaginal assisted laparoscopic hysteropexy will combined with anterior and/or posterior repair
      depending on the judgment of the surgeon at the time of the operation. Each woman will be
      followed up initially in the clinic 3 months post-surgery as part of the departmental
      routine. Participants will then invite for review, as part of the trial, at a dedicated
      clinic, 1 year following surgery. Vaginal prolapse will be assessed again using the
      International Consultation on Incontinence Questionnaire for Vaginal Symptoms (ICIQ-VS)
      questionnaire and the Pelvic Organ Prolapse Quantification (POP-Q) examination by another
      researcher then the operator. During the interview, further questions will be asked regarding
      post-operative recovery, current urinary symptoms, Urogenital Distress Inventory Short Form
      (UDI-6) and the Incontinence Impact Questionnaire Short Form (IIQ-7) and their satisfaction
      with the operation. Subjective surgical outcome will be measured using the Patient Global
      Impression of Improvement (PGI-I), which is a validated tool as a global index of response to
      prolapse surgery.

      The women's prolapse symptoms and their impact will be evaluated before surgical treatment.

        1. A subjective assessment of the prolapse will be made using the ICIQ-VS

        2. Objective assessment of pelvic organ prolapse will be performed during a Valsalva
           maneuver, in the left lateral position, using a Sims' speculum. Investigators use the
           pelvic organ prolapse quantification (POP-Q) system.

        3. Patients will be also asked to complete the Urogenital Distress Inventory Short Form
           (UDI-6) and the Incontinence Impact Questionnaire Short Form (IIQ-7). UDI-6 and IIQ-7
           are accepted as validated questionnaires that are useful in the assessment of urogenital
           symptoms and disease-specific QoL.

      The measure for primary outcome is treatment failure defined as recurrent apical prolapse
      surgery required within the first year post-operatively.

      The secondary outcome measures are change in anatomy quantified by POP-Q and symptoms
      quantified using the ICIQ-VS questionnaire scores for prolapse, sexual wellbeing, quality of
      life, and PGI-I score, UDI-6 and IIQ-7 scores. Other secondary outcome measures are operation
      time, blood loss, hospital stay, and time before return to normal activity.
    

Intervention name(s): POP-Q
Intervention type(s): Other
Intervention description(s): Pelvic Organ Prolapse Quantification
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Women attending the gynecology clinic at a tertiary referral urogynecology unit in our
        hospital requesting surgical treatment for STAGE 2-4 symptomatic uterine prolapse.
      
Keywords: vaginal hysterectomy; laparoscopic hysteropexy; pelvic organ prolapse quantification