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.
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.
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 group | Role | What they receive |
|---|---|---|
| Conventional vaginoscopy | Active comparator | Vaginoscopy without vulvar tightness Receives: Procedure: Vaginoscopy |
| Tight vaginoscopy | Active comparator | Vaginoscopy via Darwish sheet Receives: Procedure: Vaginoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
clarity of visualization of the vagina and the cervix
clear
Measured: 1 day
estimation of infused and leaked distension medium before and after application of vulvar Darwish sheet
Measured: 1 day
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.
- First posted13 May 2020
- Study start1 Jul 2014
- Primary completion1 Jan 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaginoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Woman's Health University Hospital, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Atef Darwish, Woman's Health University Hospital, Egypt
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
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simplification of Vaginoscopic Surgery Using a Self-retaining External Vulvar Sheet (Darwish Sheet)
- ClinicalTrials.gov ID
- NCT04387123
- Acronym / sponsor ID
- Darwish sheet / Darwish sheet
- Conditions
- Vaginoscopy
- Keywords
- vaginoscopy, Darwish sheet, Vagina, cervix, virgin, nullipra
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Woman's Health University Hospital, EgyptUniversity, hospital or other
- Study start
- 1 Jul 2014 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 13 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Vaginoscopy via Darwish sheet or without its use.
| Arm | Type | Receives |
|---|---|---|
| Conventional vaginoscopy | Active comparator | Procedure: VaginoscopyVaginoscopy without vulvar tightness |
| Tight vaginoscopy | Active comparator | Procedure: VaginoscopyVaginoscopy via Darwish sheet |
Who may qualify
- Ages
- 4 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- children, adolescents nulliparous adult females scheduled for vaginoscopy Suspected vaginal or cervical lesion or foreign body FB
Key exclusion criteria (1 listed)
- Multiparous patients nulliparous patients with normal, patulous or lax vaginas
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VaginoscopyVaginoscopic examination and possible operative endoscopic management | Procedure or surgery | Conventional vaginoscopy, Tight vaginoscopy |
Primary outcome
clarity of visualization of the vagina and the cervix
Time frame: 1 day
clear
estimation of infused and leaked distension medium before and after application of vulvar Darwish sheet
Time frame: 1 day
the success rate of operative TV whenever indicated
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2020.
- Individual participant dataSharing planned: No
Related trials for Vaginoscopy
Recruiting
Office Hysteroscopy in Postmenopausal Women: A Randomized Trial of Cervical Preparation Strategies
Postmenopausal Women, Intrauterine Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.