Simplification of Vaginoscopic Surgery Using a Self-retaining External Vulvar Sheet (Darwish Sheet)
Condition: Vaginoscopy
Study type: Interventional

Summary: 
      Vaginoscopic examination is usually difficult due to continuous leakage of the distension
      medium from the introitus. This study aims to assess the effectiveness and success of
      performing diagnostic or operative vaginoscopic surgery via a tight self-retaining external
      vulvar sheet (Darwish sheet) expressed as tight vaginoscopy (TV) compared with conventional
      vaginoscopy (CV).
    

Detailed description: 
      This is a prospective cross-sectional interventional cohort study was performed at the
      Endoscopy Unit of the Woman's Health University Hospital, Assiut, Egypt, between July 2014
      and January 2020. Participants were symptomatic patients with suspected narrow vagina. They
      were children, adolescents or nulliparous adult females scheduled for vaginoscopy to confirm
      the diagnosis and whenever indicated to remove a vaginal or cervical lesion or FB. All cases
      underwent a high-resolution 2D transabdominal ultrasonography with full-bladder technique to
      assess the vaginal integrity, length and width. If a mass was seen, the examiner commented on
      its origin (whether cervical or vaginal), its echogenicity, and its dimensions. In doubtful
      cases, a pelvic MRI was requested to confirm the diagnosis. Children with suspected FB were
      subjected to plain X-ray to confirm the diagnosis. Patients with definite or suspected
      vaginal or cervical lesions were included in this study. For young girls or virgin adults,
      every effort was exerted to avoid hymenal injury during vaginoscopy on their request. All the
      cases were prepared for a vaginoscopic surgery at the regular endoscopy unit in the immediate
      postmenstrual period (if postmenarchal) but young girls were operated on at any time.

      Every patient was subjected to a sequential diagnostic conventional vaginoscopy (CV) followed
      by tight vaginoscopy (TV), and whenever required operative TV. Vulvar tightness was made
      using a self-retaining external vulvar sheet (Darwish sheet). Under general anesthesia, all
      the cases were placed in the dorsal lithotomy position. Trendelenburg position was avoided
      because it hinders access to the entire vagina and the cervix, and may increase the risk of
      gas or air embolism. For adult cases, conventional hysteroscope was used as a vaginoscope. A
      4-mm zero-degree telescope loaded inside a 5-mm outer sheath and connected to a light cable,
      with a pneumatic infusion pump for 0.9% saline irrigation, was inserted inside the vaginal
      introitus. At the investigator's institution, automatic infusion pumps are not used for
      vaginoscopic surgery as the vagina is a distensible organ unlike the uterus. The vaginoscope
      was gradually advanced inside the vagina (Figure 1) with reporting on the vaginal walls till
      the ectocervix. Proper examination of the cervix included the endocervical canal and the
      internal os. If feasible, the telescope was advanced to examine the endometrial cavity,
      searching for any associated intrauterine lesion, with a comment on the endometrial pattern
      and vasculature. Any suspected lesion was prepared for complete excision or at least biopsy
      to complete the diagnosis. On the other hand, for children, office hysteroscope (a 2.6-mm
      telescope and a 3.2-mm outer sheath) was used and the procedure was performed in the same way
      as that in adults, with exemption of uterine cavity examination. The visualized pattern of
      any vaginal or cervical lesion was reported. At the end of the procedure, the telescope
      loaded inside its sheath was extracted. The same patient was re-examined using TV. The
      vaginoscope penetrates a sterile self-retaining tight external silicone vulvar sheet (Darwish
      sheet) measuring 20x15 cm which is tied around the patient waist (Figure 2) with a central
      linear incision of 10 mm aiming to minimize the reflux of the irrigating fluid from the
      vagina. Comment on the appearance of the normal anatomy of the vagina (Figure 1) and the
      cervix, (Figure 3) any vaginal or cervical lesion like cervical polyps (figure 3,4) or
      foreign bodies (FB) (Figure 4), or a vaginal septum (video) was made. Importantly, the
      surgeon commented on clarity of visualization, amount of used and leaked 0.9% saline before
      and after application of Darwish sheet on the vulva.

      For operative TV, a 27-Fr rotatory resectoscope loaded inside the sterile self-retaining
      tight external silicone vulvar sheet (Darwish sheet). Glycine 1.5% was used for monopolar
      resectoscopy. Vaginal or cervical polyps were excised by a loop electrode, while vaginal
      septum was cut using a hook electrode. FB was extracted using a flexible grasping forceps
      inserted in the vagina alongside the vaginoscope; if any difficulty was faced, the telescope
      was loaded inside rigid grasping forceps to extract the FB. A comment on the feasibility of
      surgery (clarity of visualization and access to the lesion), operative time and any possible
      complications was made. The amount of irrigated distension medium as well as escaped amount
      in the suction unit and that collected in a sterile plastic bag embedded under the buttocks
      of the patient were collected and measured after every case of the diagnostic CV, diagnostic
      TV, and operative TV. All endoscopic equipment was manufactured by Storz Co. (Tuttlingen,
      Germany). All excised tissues were sent for histopathologic assessment. The attached video
      shows different cases of diagnostic and operative vaginoscopy before and after application of
      Darwish sheet. The main outcome measures included clarity of visualization of the vagina and
      the cervix, estimation of infused and leaked distension medium before and after application
      of vulvar Darwish sheet and the success rate of operative TV whenever indicated.
      Postoperatively, the patients were kept under observation for 2-4 h and discharged whenever
      stable. All cases were followed up at least once after the next menses and examined
      clinically and by ultrasonography.
    

Intervention name(s): Vaginoscopy
Intervention type(s): Procedure
Intervention description(s): Vaginoscopic examination and possible operative endoscopic management
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: Vaginoscopy via Darwish sheet or without its use.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: vaginoscopy; Darwish sheet; Vagina; cervix; virgin; nullipra