Laparoscopic Versus Transvaginal Cuff Closure
Condition: Vaginal Cuff Dehiscence; Vaginal Hematoma; Vaginal Infection
MeSH terms: Hematoma
Study type: Interventional

Summary: 
      It is still debatable whether that the transvaginal approach to vault closure or laparoscopic
      suturing are associated with lower risks of vaginal cuff complications .

      This study aims to compare the two approaches of closure of the vaginal cuff at the end of
      total laparoscopic hysterectomy as regards the vaginal cuff complications .
    

Detailed description: 
      All the women will subject to:

      Preoperative Assessment including:

        -  Detailed history taking including age ,parity, medical ,surgical history .

        -  Physical examination:

             -  General examination including the body mass index .

             -  Abdominal examination including presence of previous scars, uterine size , any
                tenderness and presence of palpable masses .

             -  Pelvic examination: including uterine size, any adnexal mass and tenderness .

        -  Preoperative investigation:

             -  A preoperative trans-vaginal ultra- sonography to assess the volume of the uterus,
                gross uterine pathology and any adnexal pathology.

             -  The preoperative laboratory investigation: hemoglobin percent and haematocrit
                value, blood grouping ,liver and kidney function tests.

      Availability of blood was ensured for each patient before surgery.

      Anaesthesia:

      Standardized general anaesthetic technique consisting of induction agent, muscle-relaxant and
      inhalational agents with basic minimum monitoring after a detailed pre-anaesthetic check-up
      and adequate premedication advice.

      Intraoperative :

        -  For vaginal cuff closure both in laparoscopic approach and vaginal route, the
           investigators will use the horizontal method, which can be described as closing the
           vagina anterior to posterior by leaving a horizontal scar. The repair will start at one
           end of the vaginal cuff, and will continue toward the surgeon , using a continuous
           Vicryl suture .

        -  In the laparoscopic approach, needles will be introduced through one trocar and removed
           through the opposite trocars using a needle holders.

      Postoperative care:

        1. The patient will receive IV fluids in the first 24hours (3litres).

        2. Oral clear fluid intake will be started 8 hours after the operation.

        3. Another dose of antibiotics will be received 6hrs after the operation with the same
           regimen used in induction.

        4. Postoperative analgesia will be received in the form of parental NSAIDs every 8hrs for
           24hrs then on demand.

        5. The urinary catheter and the vaginal pack will be removed 24hrs after the operation , no
           drains will be left intraoperative.

        6. CBC will be done 24hrs after the operation.

        7. Histopathological examination of the specimen will be done.

        8. Precocious resumption of coital activity ,( all patients will be recommended to avoid
           vaginal intercourse for at least 2 months ) .

      Follow Up:

        -  Transvaginal ultrasound will be done to all patients in the second day to Spot vaginal
           cuff hematoma if found .

        -  Women will be discharged on antibiotic ( third generation cephalosporins ) and
           analgesics ( NSAIDs ) and a follow-up visit will be scheduled after 7 days for a full
           examination to exclude vaginal cuff infection ( purulent drainage from the vaginal cuff
           on gross anatomic exam according to CDC ) or cuff hematoma (Any blood collection at the
           level of vaginal vault detected by transvaginal ultrasound).

        -  All women will be followed up after 3 months for the occurrence of vaginal cuff
           dehiscence (separation of a vaginal incision that was previously closed at time of
           initial hysterectomy) , at that time all women will undergo abdominal examination and
           bimanual pelvic examination for vaginal masses.

        -  All women will be asked for dyspareunia according to Marinoff scale:

           0= no pain with intercourse .

             1. pain with intercourse that doesn't prevent the completion .

             2. pain with intercourse requiring interruption or discontinuance .

             3. pain with intercourse preventing any intercourse .

        -  Ethical Considerations:

        -  Patient information and informed consent:

      Before being admitted to the clinical study, the patient must consent to participate after
      the nature, scope and possible consequences of the clinical study have been explained in a
      form understandable to her.

      Protocol approval:

      Before the beginning of the study and in accordance with the local regulation followed, the
      protocol and all the corresponding documents will be declared for Ethical and Research
      approval by the council of the OB/GYN department, Ain Shams University.

      Assessment of the outcomes:

      Primary outcomes:

      1. Vaginal cuff dehiscence: Any separation at the level of the vaginal vault.

      Secondary outcomes:

        1. Vaginal cuff hematoma:

           Any blood collection at the level of vaginal vault detected by transvaginal ultrasound.

        2. Post operative pelvic infections:

           Any postoperative infection with signs and symptoms of vaginal cuff involvement
           including granulation formation .

        3. Operative time:

           Time spent in suturing the vaginal cuff transvaginally versus laparoscopically .

        4. Incidence of dyspareunia : according to Marinoff scale .
    

Intervention name(s): laparoscopical l cuff closure
Intervention type(s): Biological
Intervention description(s): closure of vaginal cuff following hysterectomy
Other intervention name(s): transvaginal cuff closure
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment