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VaginoscopyDarwish sheetNCT04387123

Simplification of Vaginoscopic Surgery Using a Self-retaining External Vulvar Sheet (Darwish Sheet)

A study testing Vaginoscopy in people with Vaginoscopy, run by Woman's Health University Hospital, Egypt at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 4 to 25 years, women only
Conditions the study is for
Vaginoscopy
What is being tested?
Vaginoscopy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteEgypt
Study dates
1 Jul 2014to 1 May 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 25 years
  • Women only
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • children, adolescents nulliparous adult females scheduled for vaginoscopy Suspected vaginal or cervical lesion or foreign body FB

Who cannot join

  • Multiparous patients nulliparous patients with normal, patulous or lax vaginas

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Woman's Health University Hospital

    Asyut, 71111

Other trials in Egypt

About this study

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).

Read the 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.

Conditions
Vaginoscopy
Being tested
Vaginoscopy
Keywords
vaginoscopy, Darwish sheet, Vagina, cervix, virgin, nullipra

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VaginoscopyProcedure or surgery

    Vaginoscopic examination and possible operative endoscopic management

Study groups in NCT04387123
Study groupRoleWhat they receive
Conventional vaginoscopyActive comparatorVaginoscopy without vulvar tightness
Receives: Procedure: Vaginoscopy
Tight vaginoscopyActive comparatorVaginoscopy via Darwish sheet
Receives: Procedure: Vaginoscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. clarity of visualization of the vagina and the cervix

    clear

    Measured: 1 day

  2. estimation of infused and leaked distension medium before and after application of vulvar Darwish sheet

    Measured: 1 day

  3. the success rate of operative TV whenever indicated

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2020
  2. Study start1 Jul 2014
  3. Primary completion1 Jan 2020
  4. Study completion1 May 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Model description
Vaginoscopy via Darwish sheet or without its use.
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04387123
Sponsor's protocol ID
Darwish sheet
Acronym
Darwish sheet
Status last verified
May 2020
First submitted
8 May 2020
Last updated
13 May 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Vaginoscopy in people with Vaginoscopy, run by Woman's Health University Hospital, Egypt at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

clarity of visualization of the vagina and the cervix (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2020.

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