Gynecologic DiseaseOWardaNCT05125692
Vaginal Repair of Post Cesarean Istmocele
A study testing vaginal surgical repair of isthmocele in people with Gynecologic Disease, run by Mansoura University at 1 site in Egypt.
Trial summary
20 WOMEN WITH SYMPTOMATIC POSTCESAREAN ISTHMOCELE (NICHE) WILL BE RECRUITED EVALUATED AND SUBJECTED TO A VAGINAL REPAIR OF THE DEFECT, RESULTS WILL BE ANALYZED. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Gynecologic Disease
- What is being tested?
- vaginal surgical repair of isthmocele
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Sep 2021to 20 Dec 2022
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women diagnosed with symptomatic post cesarean isthmocele.
- should present with abnormal uterine bleeding .
Who cannot join
- presence of any other uterine pathology,
- presence of adnexal pathology,
- presence of malignancies,
- presence of pregnancy,
- presence of infection in the lower genital tract ,
- general cause of bleeding
- women not accepting the procedure,
- women not consented
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mansoura University Hospitals
Al Mansurah, Dakahlya Governorate, 35516
osama m warda, MD, 01066153212 ext. +20, osamawarda@mans.edu.eg
osama m warda, MD
About this study
Official title: Vaginal Repair of Symptomatic Postcesarean Isthmocele: Evaluating A Simple Novel Technique
20 WOMEN WITH SYMPTOMATIC POSTCESAREAN ISTHMOCELE (NICHE) WILL BE RECRUITED EVALUATED AND SUBJECTED TO A VAGINAL REPAIR OF THE DEFECT, RESULTS WILL BE ANALYZED.
Read the detailed description
METHODS:
- Subjects: women in childbearing period with abnormal uterine bleeding or infertility attributed to post cesarean isthmocele (sample size to be calculated)
- Preoperative evaluation: transvaginal ultrasound to exclude any other uterine or adnexal pathology, and to measure:
- Distance from the external cervical os to the lower end of the isthmocele (A)
- Distance from the external cervical os to the upper end of the isthmocele(B)
- Length of the isthmocele (B-A)
- Residual myometrial thickness (the least) of the isthmocele.
- Routine preoperative workup.
- The technique:
- Postmenstrual
- Spinal anesthesia
- Sterilization of the perineum and vagina
- Cervical dilation up to 8mm using Hegar's dilators
- Marking the previously measured points A \& B
- Making 2 transverse incisions, one 5mm below A and the other 5 mm above B.
- The rectangular area between the 2 incisions is excised while the Hegar's dilator number 8 in in situ.
- Hemostasis is performed using diathermy.
- The upper and lower edges of the incision are approximated using number 2/0 vicryl on cutting needle taking 3 to 4 interrupted sutures
- The patients with uneventful postoperative course are discharged from hospital after 8 hours with doxycycline 100 mg bid for 5 days.
- Sexual intercourse is avoided for 4 weeks postoperative
- postoperative transvaginal ultrasound follow up; at 1 month postoperative.
- Data will be statistically analyzed and results will be tabulated.
- Conditions
- Gynecologic Disease
- Being tested
- vaginal surgical repair of isthmocele
- Medical subject headings
- Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vaginal surgical repair of isthmoceleProcedure or surgery
after preoperative identification of the borders of the isthmocele using transvaginal ultrasound measurements, the isthmocele is repaired via vaginal approach
| Study group | Role | What they receive |
|---|---|---|
| women with symptomatic post cesarean Istmocele | Other | vaginal surgical repair of post cesarean symptomatic isthmocele using conventional low cost surgical techniques Receives: Procedure: vaginal surgical repair of isthmocele |
What is being measured
The primary outcome is the main question the study is designed to answer.
myometrial thickness in supracervical area
the myometrial thickness in the supracervical region is measured by transvaginal ultrasound postoperatively
Measured: at 1 month postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start4 Sep 2021
- Primary completion20 Aug 2022 (estimated)
- Study completion20 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic DiseaseStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- WOMEN IN CHILDBEARING PERIOD WITH SYMPTOMATIC POSTCESAREAN ISTHMOCELE
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05125692
- Sponsor's protocol ID
- osama Istmocele
- Acronym
- OWarda
- Status last verified
- Sep 2021
- First submitted
- 15 Sep 2021
- Last updated
- 18 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Repair of Symptomatic Postcesarean Isthmocele: Evaluating A Simple Novel Technique
- ClinicalTrials.gov ID
- NCT05125692
- Acronym / sponsor ID
- OWarda / osama Istmocele
- Conditions
- Gynecologic Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 4 Sep 2021 (actual)
- Primary completion
- 20 Aug 2022 (estimated)
- Study completion
- 20 Dec 2022 (estimated)
- First posted
- 18 Nov 2021 (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.
20 WOMEN WITH SYMPTOMATIC POSTCESAREAN ISTHMOCELE (NICHE) WILL BE RECRUITED EVALUATED AND SUBJECTED TO A VAGINAL REPAIR OF THE DEFECT, RESULTS WILL BE ANALYZED.
Detailed description
METHODS:
- Subjects: women in childbearing period with abnormal uterine bleeding or infertility attributed to post cesarean isthmocele (sample size to be calculated)
- Preoperative evaluation: transvaginal ultrasound to exclude any other uterine or adnexal pathology, and to measure:
- Distance from the external cervical os to the lower end of the isthmocele (A)
- Distance from the external cervical os to the upper end of the isthmocele(B)
- Length of the isthmocele (B-A)
- Residual myometrial thickness (the least) of the isthmocele.
- Routine preoperative workup.
- The technique:
- Postmenstrual
- Spinal anesthesia
- Sterilization of the perineum and vagina
- Cervical dilation up to 8mm using Hegar's dilators
- Marking the previously measured points A \& B
- Making 2 transverse incisions, one 5mm below A and the other 5 mm above B.
- The rectangular area between the 2 incisions is excised while the Hegar's dilator number 8 in in situ.
- Hemostasis is performed using diathermy.
- The upper and lower edges of the incision are approximated using number 2/0 vicryl on cutting needle taking 3 to 4 interrupted sutures
- The patients with uneventful postoperative course are discharged from hospital after 8 hours with doxycycline 100 mg bid for 5 days.
- Sexual intercourse is avoided for 4 weeks postoperative
- postoperative transvaginal ultrasound follow up; at 1 month postoperative.
- Data will be statistically analyzed and results will be tabulated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- WOMEN IN CHILDBEARING PERIOD WITH SYMPTOMATIC POSTCESAREAN ISTHMOCELE
| Arm | Type | Receives |
|---|---|---|
| women with symptomatic post cesarean Istmocele | Other | Procedure: vaginal surgical repair of isthmocelevaginal surgical repair of post cesarean symptomatic isthmocele using conventional low cost surgical techniques |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- women diagnosed with symptomatic post cesarean isthmocele.
- should present with abnormal uterine bleeding .
Key exclusion criteria (8 listed)
- presence of any other uterine pathology,
- presence of adnexal pathology,
- presence of malignancies,
- presence of pregnancy,
- presence of infection in the lower genital tract ,
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 |
|---|---|---|
| vaginal surgical repair of isthmoceleafter preoperative identification of the borders of the isthmocele using transvaginal ultrasound measurements, the isthmocele is repaired via vaginal approach | Procedure or surgery | women with symptomatic post cesarean Istmocele |
Primary outcome
myometrial thickness in supracervical area
Time frame: at 1 month postoperative
the myometrial thickness in the supracervical region is measured by transvaginal ultrasound postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vaginal surgical repair of isthmocele in people with Gynecologic Disease, run by Mansoura University 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 2 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 18 Nov 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact osama M Warda, MD (01066153212 ext. +20, osamawarda@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
myometrial thickness in supracervical area (time frame: at 1 month postoperative). 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 18 Nov 2021.