IsthmoceleNCT07625852
Impact of Vertical vs. Transverse Closure on Outcomes of Laparoscopic Correction of Isthmocele
A study testing Vertical Closure and Transverse Closure in people with Isthmocele, run by Minia University.
Trial summary
Laparoscopic repair of Isthmocele aims to restore the anatomical integrity and physiological function of the lower uterine segment. Vertical Closure: This technique involves closing the defect along the longitudinal axis of the uterus. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Isthmocele
- What is being tested?
- Vertical Closure and Transverse Closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 18-45 years.
- Diagnosis of symptomatic isthmocele confirmed by transvaginal ultrasound (myometrial thickness at the defect < 2.5 mm).
- History of at least one prior cesarean section.
- Symptoms attributable to isthmocele (e.g., abnormal uterine bleeding, pelvic pain, dysmenorrhea, secondary infertility).
- Desire for surgical correction of isthmocele.
- Ability to understand and provide informed consent
Who cannot join
- Asymptomatic isthmocele.
- Active pelvic infection or malignancy.
- Significant medical comorbidities contraindicating laparoscopic surgery.
- Coagulopathy.
- Known uterine anomalies (e.g., bicornuate uterus).
- Pregnancy at the time of recruitment.
- Inability to comply with follow-up protocol.
About this study
Laparoscopic repair of Isthmocele aims to restore the anatomical integrity and physiological function of the lower uterine segment.
- Vertical Closure: This technique involves closing the defect along the longitudinal axis of the uterus. Proponents suggest it may be more anatomically aligned with the muscle fibers of the lower uterine segment, potentially leading to stronger scar formation and reduced tension.
- Transverse Closure: This technique involves closing the defect perpendicular to the long axis of the uterus. This approach is more commonly used during primary cesarean sections.
Read more
Arguments for transverse closure in isthmocele repair include familiarity for surgeons and potentially less shortening of the lower uterine segment.
However, the actual impact of these different closure methods on long-term outcomes such as defect recurrence, scar integrity, and fertility, remains largely unexplored in a randomized controlled trial setting.
Read the detailed description
Isthmocele, also known as a cesarean scar defect (CSD), is a common complication following cesarean section, characterized by a myometrial defect at the site of the hysterotomy scar. It can lead to various symptoms including abnormal uterine bleeding, dysmenorrhea, pelvic pain, and infertility.
Laparoscopic repair aims to restore the anatomical integrity and physiological function of the lower uterine segment.
- Vertical Closure: This technique involves closing the defect along the longitudinal axis of the uterus. Proponents suggest it may be more anatomically aligned with the muscle fibers of the lower uterine segment, potentially leading to stronger scar formation and reduced tension.
- Transverse Closure: This technique involves closing the defect perpendicular to the long axis of the uterus. This approach is more commonly used during primary cesarean sections.
Arguments for transverse closure in isthmocele repair include familiarity for surgeons and potentially less shortening of the lower uterine segment.
However, the actual impact of these different closure methods on long-term outcomes such as defect recurrence, scar integrity, and fertility, remains largely unexplored in a randomized controlled trial setting.
- Conditions
- Isthmocele
- Being tested
- Vertical Closure, Transverse Closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vertical ClosureProcedure or surgery
The hysterotomy defect will be closed in two layers using interrupted or continuous sutures along the longitudinal axis of the uterus
Transverse ClosureProcedure or surgery
The hysterotomy defect will be closed in two layers using interrupted or continuous sutures perpendicular to the longitudinal axis of the uterus
| Study group | Role | What they receive |
|---|---|---|
| Vertical Closure Group | Active comparator | The hysterotomy defect will be closed in two layers using interrupted or continuous sutures along the longitudinal axis of the uterus Receives: Procedure: Vertical Closure |
| Transverse Closure Group | Active comparator | The hysterotomy defect will be closed in two layers using interrupted or continuous sutures perpendicular to the longitudinal axis of the uterus Receives: Procedure: Transverse Closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative lower uterine segment scar thickness
To evaluate the thickness of the lower uterine segment scar at 6 and 12 months post-surgery using transvaginal ultrasound
Measured: 6 and 12 months post-surgery using transvaginal ultrasound
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IsthmoceleStudies of the same condition, open and under way.
- More trials run by Minia 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Hassan Mohamed Abdel Ghfar, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07625852
- Sponsor's protocol ID
- 1704-9-2025
- Status last verified
- May 2026
- First submitted
- 29 May 2026
- Last updated
- 4 Jun 2026
- 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 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Vertical vs. Transverse Closure on Outcomes of Laparoscopic Correction of Isthmocele
- ClinicalTrials.gov ID
- NCT07625852
- Acronym / sponsor ID
- 1704-9-2025
- Conditions
- Isthmocele
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 4 Jun 2026 (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.
Laparoscopic repair of Isthmocele aims to restore the anatomical integrity and physiological function of the lower uterine segment.
- Vertical Closure: This technique involves closing the defect along the longitudinal axis of the uterus. Proponents suggest it may be more anatomically aligned with the muscle fibers of the lower uterine segment, potentially leading to stronger scar formation and reduced tension.
- Transverse Closure: This technique involves closing the defect perpendicular to the long axis of the uterus. This approach is more commonly used during primary cesarean sections.
Arguments for transverse closure in isthmocele repair include familiarity for surgeons and potentially less shortening of the lower uterine segment.
However, the actual impact of these different closure methods on long-term outcomes such as defect recurrence, scar integrity, and fertility, remains largely unexplored in a randomized controlled trial setting.
Detailed description
Isthmocele, also known as a cesarean scar defect (CSD), is a common complication following cesarean section, characterized by a myometrial defect at the site of the hysterotomy scar. It can lead to various symptoms including abnormal uterine bleeding, dysmenorrhea, pelvic pain, and infertility.
Laparoscopic repair aims to restore the anatomical integrity and physiological function of the lower uterine segment.
- Vertical Closure: This technique involves closing the defect along the longitudinal axis of the uterus. Proponents suggest it may be more anatomically aligned with the muscle fibers of the lower uterine segment, potentially leading to stronger scar formation and reduced tension.
- Transverse Closure: This technique involves closing the defect perpendicular to the long axis of the uterus. This approach is more commonly used during primary cesarean sections.
Arguments for transverse closure in isthmocele repair include familiarity for surgeons and potentially less shortening of the lower uterine segment.
However, the actual impact of these different closure methods on long-term outcomes such as defect recurrence, scar integrity, and fertility, remains largely unexplored in a randomized controlled trial setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vertical Closure Group | Active comparator | Procedure: Vertical ClosureThe hysterotomy defect will be closed in two layers using interrupted or continuous sutures along the longitudinal axis of the uterus |
| Transverse Closure Group | Active comparator | Procedure: Transverse ClosureThe hysterotomy defect will be closed in two layers using interrupted or continuous sutures perpendicular to the longitudinal axis of the uterus |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women aged 18-45 years.
- Diagnosis of symptomatic isthmocele confirmed by transvaginal ultrasound (myometrial thickness at the defect < 2.5 mm).
- History of at least one prior cesarean section.
- Symptoms attributable to isthmocele (e.g., abnormal uterine bleeding, pelvic pain, dysmenorrhea, secondary infertility).
- Desire for surgical correction of isthmocele.
Key exclusion criteria (7 listed)
- Asymptomatic isthmocele.
- Active pelvic infection or malignancy.
- Significant medical comorbidities contraindicating laparoscopic surgery.
- Coagulopathy.
- Known uterine anomalies (e.g., bicornuate uterus).
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 |
|---|---|---|
| Vertical ClosureThe hysterotomy defect will be closed in two layers using interrupted or continuous sutures along the longitudinal axis of the uterus | Procedure or surgery | Vertical Closure Group |
| Transverse ClosureThe hysterotomy defect will be closed in two layers using interrupted or continuous sutures perpendicular to the longitudinal axis of the uterus | Procedure or surgery | Transverse Closure Group |
Primary outcome
Postoperative lower uterine segment scar thickness
Time frame: 6 and 12 months post-surgery using transvaginal ultrasound
To evaluate the thickness of the lower uterine segment scar at 6 and 12 months post-surgery using transvaginal ultrasound
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Vertical Closure and Transverse Closure in people with Isthmocele, run by Minia University.
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 6 inclusion and 7 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: opening soon, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Postoperative lower uterine segment scar thickness (time frame: 6 and 12 months post-surgery using transvaginal ultrasound). 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 4 Jun 2026.