Cesarean Scar NicheNCT05777837
Laparoscopic Versus Combined Laparoscopic and Hysteroscopic Repair of CS Niche
A study testing laparoscopic repair of cesarean scar niche and Combined hysteroscopic and laparoscopic repair of cesarean scar niche in people with Cesarean Scar Niche, run by Zagazig University at 1 site in Egypt.
Trial summary
Uterine niche is a frequent condition in patients with a history of cesarean section. Many treatment methods have been described for repair of niche with varying effectivities. In conventional Laparoscopic approach, not all bleeding points and fibrotic area are resected, while conventional hysteroscopic one result in… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Cesarean Scar Niche
- What is being tested?
- laparoscopic repair of cesarean scar niche and Combined hysteroscopic and laparoscopic repair of cesarean scar niche
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2023to 1 May 2024
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- History of cesarean section Postmenstrual and or intermenstrual spotting Large Cesarean scar niche, depth more than 50% of adjacent myometrial thickness (AMT).
- Failed medical treatment Signed informed consent.
Who cannot join
- A contraindication for a hysteroscopic niche resection Women with a positive pregnancy test. A contraindication for general or local anaesthesia. Coagulation disorders that lead to higher risks on bleeding or anticoagulant use.
- A (suspected) malignancy, endometrial polyps, atypical endometrial cells, cervical dysplasia, hydrosalpinx that may communicate with the uterus.
- Adenomyosis or leiomyoma (the International Federation of Gynecology and Obstetrics (FIGO) leiomyomia subclassification system Type 0, 1, 2, 3) or large leiomyomas causing the uterine cavity length to be ≥ 9 cm as examined by transvaginal ultrasound or MRI.
- Endocrine disorders that interfere with the menstrual cycle. Irregular menstrual cycle (>35 days or intercycle variation of 2 weeks or more).
- Patients who are not willing to conceive before and/or after the hysteroscopic surgery.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine
Zagazig
Ahmed Ismail, lecturer Obs & gyn
About this study
Official title: Laparoscopic Excision Versus Combined Hysteroscopic and Laparoscopic Repair Without Excision of Large Cesarean Scar Niche: A Randomized Controlled Trial
Uterine niche is a frequent condition in patients with a history of cesarean section. Many treatment methods have been described for repair of niche with varying effectivities. In conventional Laparoscopic approach, not all bleeding points and fibrotic area are resected, while conventional hysteroscopic one result in more wide defect with high risk of recurrence and cannot be used in large niche with low RMT. In this new Double approach (hysteroscopy and laparoscopy) technique, the benefit of both laparoscopy and hysteroscopy will be attained.
Read the detailed description
In all patient involved in the study, laparoscopic entry will be done, then adhesiolysis and creation of the bladder flap(dissection of the bladder from the uterine scar) then:
Group (I): Laparoscopic Excision of large cesarean scar niche:
Intentional perforation of the niche will be done using uterine sound and excision of the fibrotic edges then suturing the uterine incision using 2-0 absorbable suture.
Group (II): Combined hysteroscopic and laparoscopic repair without excision of large cesarean scar niche:
The investigators will do the hysteroscopic resection of the niche under laparoscopic guide to avoid perforation of the niche. After completion of the hysteroscopic approach, laparoscopic plication of the niche without opening it will be done using multiple interrupted 2-0 absorbable suture After suturing, the hysteroscopy will be introduced again to assess the repair The patient will be sent home the day after. They will be followed up after 3 and 6 months.
Checkup of CSD repair:
After 6 month of surgery both groups will be examined using sonohysterography to assess the changes in niche diameters
Core outcome sets:
- Enlargement of the residual myometrium thickness and reduction of postmenstrual bleeding will be measured at the 3-month and 6-month.
- Subsequent fertility outcome
- Conditions
- Cesarean Scar Niche
- Being tested
- laparoscopic repair of cesarean scar niche, Combined hysteroscopic and laparoscopic repair of cesarean scar niche
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic repair of cesarean scar nicheProcedure or surgery
Also called laparoscopic excision of cesarean scar niche
Intentional perforation of the niche will be done using uterine sound and excision of the fibrotic edges then suturing the uterine incision using 2-0 absorbable suture.
Combined hysteroscopic and laparoscopic repair of cesarean scar nicheProcedure or surgery
Also called Combined hysteroscopic and laparoscopic repair without excision of large cesarean scar niche
Hysteroscopic resection of the niche under laparoscopic guide will be done to avoid perforation of the niche. After completion of the hysteroscopic approach, laparoscopic plication of the niche without opening it will be done using multiple interrupted 2-0 absorbable suture.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Excision of Large Cesarean Scar Niche | Active comparator | Not described Receives: Procedure: laparoscopic repair of cesarean scar niche |
| Combined Hysteroscopic and Laparoscopic Repair without Excision of Large Cesarean Scar Niche | Active comparator | Not described Receives: Procedure: Combined hysteroscopic and laparoscopic repair of cesarean scar niche |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of the residual myometrium thickness
ultrasound measurement of the residual myometrium will be done
Measured: will be measured at the 3-month and 6-month
reduction of postmenstrual bleeding
participants will report their perception of the amount of bleeding using a questionnaire
Measured: will be assessed at the 3-month and 6-month
Secondary outcomes (1)
Subsequent fertility outcome
the incidence of subsequent conception following intervention will be recorded
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start1 Apr 2023 (estimated)
- Primary completion1 Apr 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Cesarean Scar NicheStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mahmoud Abubakr Negm, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05777837
- Sponsor's protocol ID
- CS scar niche repair
- Status last verified
- Mar 2023
- First submitted
- 25 Feb 2023
- Last updated
- 21 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: data may be used for another study
Publications
Almarzuki, U. H., Ahmed, T. A. F., AlBehedy, T. M., et al. (2022). Evaluation of Anatomical Characteristics of Cesarean Scar Niche by Sonohysterography and Diagnostic Hysteroscopy in Women with Secondary Infertility. The Egyptian Journal of Hospital Medicine, 88(1), 2904-2909.
Bakaviciute G, Spiliauskaite S, Meskauskiene A, Ramasauskaite D. Laparoscopic repair of the uterine scar defect - successful treatment of secondary infertility: a case report and literature review. Acta Med Litu. 2016;23(4):227-231. doi: 10.6001/actamedica.v23i4.3424.
PubMed 28356813Betran AP, Ye J, Moller AB, Zhang J, Gulmezoglu AM, Torloni MR. The Increasing Trend in Caesarean Section Rates: Global, Regional and National Estimates: 1990-2014. PLoS One. 2016 Feb 5;11(2):e0148343. doi: 10.1371/journal.pone.0148343. eCollection 2016.
PubMed 26849801Bij de Vaate AJ, van der Voet LF, Naji O, Witmer M, Veersema S, Brolmann HA, Bourne T, Huirne JA. Prevalence, potential risk factors for development and symptoms related to the presence of uterine niches following Cesarean section: systematic review. Ultrasound Obstet Gynecol. 2014 Apr;43(4):372-82. doi: 10.1002/uog.13199.
PubMed 23996650Donnez O, Donnez J, Orellana R, Dolmans MM. Gynecological and obstetrical outcomes after laparoscopic repair of a cesarean scar defect in a series of 38 women. Fertil Steril. 2017 Jan;107(1):289-296.e2. doi: 10.1016/j.fertnstert.2016.09.033. Epub 2016 Nov 2.
PubMed 27816234Cohen SB, Bouaziz J, Bar On A, Orvieto R. Fertility success rates in patients with secondary infertility and symptomatic cesarean scar niche undergoing hysteroscopic niche resection. Gynecol Endocrinol. 2020 Oct;36(10):912-916. doi: 10.1080/09513590.2020.1716327. Epub 2020 Jan 27.
PubMed 31984814Jordans IPM, de Leeuw RA, Stegwee SI, Amso NN, Barri-Soldevila PN, van den Bosch T, Bourne T, Brolmann HAM, Donnez O, Dueholm M, Hehenkamp WJK, Jastrow N, Jurkovic D, Mashiach R, Naji O, Streuli I, Timmerman D, van der Voet LF, Huirne JAF. Sonographic examination of uterine niche in non-pregnant women: a modified Delphi procedure. Ultrasound Obstet Gynecol. 2019 Jan;53(1):107-115. doi: 10.1002/uog.19049.
PubMed 29536581Stegwee SI, Beij A, de Leeuw RA, Mokkink LB, van der Voet LF, Huirne JAF. Niche-related outcomes after caesarean section and quality of life: a focus group study and review of literature. Qual Life Res. 2020 Apr;29(4):1013-1025. doi: 10.1007/s11136-019-02376-6. Epub 2019 Dec 16.
PubMed 31845165Vervoort A, Vissers J, Hehenkamp W, Brolmann H, Huirne J. The effect of laparoscopic resection of large niches in the uterine caesarean scar on symptoms, ultrasound findings and quality of life: a prospective cohort study. BJOG. 2018 Feb;125(3):317-325. doi: 10.1111/1471-0528.14822. Epub 2017 Aug 28.
PubMed 28703935Vrijdaghs V, Dewilde K, Froyman W, Van den Bosch T. Hysteroscopic management of caesarean scar defects. J Obstet Gynaecol. 2022 Jul;42(5):816-822. doi: 10.1080/01443615.2021.2003310. Epub 2022 Jan 11.
PubMed 35014923
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Excision Versus Combined Hysteroscopic and Laparoscopic Repair Without Excision of Large Cesarean Scar Niche: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05777837
- Acronym / sponsor ID
- CS scar niche repair
- Conditions
- Cesarean Scar Niche
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 21 Mar 2023 (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.
Uterine niche is a frequent condition in patients with a history of cesarean section. Many treatment methods have been described for repair of niche with varying effectivities. In conventional Laparoscopic approach, not all bleeding points and fibrotic area are resected, while conventional hysteroscopic one result in more wide defect with high risk of recurrence and cannot be used in large niche with low RMT. In this new Double approach (hysteroscopy and laparoscopy) technique, the benefit of both laparoscopy and hysteroscopy will be attained.
Detailed description
In all patient involved in the study, laparoscopic entry will be done, then adhesiolysis and creation of the bladder flap(dissection of the bladder from the uterine scar) then:
Group (I): Laparoscopic Excision of large cesarean scar niche:
Intentional perforation of the niche will be done using uterine sound and excision of the fibrotic edges then suturing the uterine incision using 2-0 absorbable suture.
Group (II): Combined hysteroscopic and laparoscopic repair without excision of large cesarean scar niche:
The investigators will do the hysteroscopic resection of the niche under laparoscopic guide to avoid perforation of the niche. After completion of the hysteroscopic approach, laparoscopic plication of the niche without opening it will be done using multiple interrupted 2-0 absorbable suture After suturing, the hysteroscopy will be introduced again to assess the repair The patient will be sent home the day after. They will be followed up after 3 and 6 months.
Checkup of CSD repair:
After 6 month of surgery both groups will be examined using sonohysterography to assess the changes in niche diameters
Core outcome sets:
- Enlargement of the residual myometrium thickness and reduction of postmenstrual bleeding will be measured at the 3-month and 6-month.
- Subsequent fertility outcome
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Excision of Large Cesarean Scar Niche | Active comparator | Procedure: laparoscopic repair of cesarean scar niche |
| Combined Hysteroscopic and Laparoscopic Repair without Excision of Large Cesarean Scar Niche | Active comparator | Procedure: Combined hysteroscopic and laparoscopic repair of cesarean scar niche |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- History of cesarean section Postmenstrual and or intermenstrual spotting Large Cesarean scar niche, depth more than 50% of adjacent myometrial thickness (AMT).
- Failed medical treatment Signed informed consent.
Key exclusion criteria (5 listed)
- A contraindication for a hysteroscopic niche resection Women with a positive pregnancy test. A contraindication for general or local anaesthesia. Coagulation disorders that lead to higher risks on bleeding or anticoagulant use.
- A (suspected) malignancy, endometrial polyps, atypical endometrial cells, cervical dysplasia, hydrosalpinx that may communicate with the uterus.
- Adenomyosis or leiomyoma (the International Federation of Gynecology and Obstetrics (FIGO) leiomyomia subclassification system Type 0, 1, 2, 3) or large leiomyomas causing the uterine cavity length to be ≥ 9 cm as examined by transvaginal ultrasound or MRI.
- Endocrine disorders that interfere with the menstrual cycle. Irregular menstrual cycle (>35 days or intercycle variation of 2 weeks or more).
- Patients who are not willing to conceive before and/or after the hysteroscopic surgery.
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 |
|---|---|---|
| laparoscopic repair of cesarean scar nicheAlso: laparoscopic excision of cesarean scar nicheIntentional perforation of the niche will be done using uterine sound and excision of the fibrotic edges then suturing the uterine incision using 2-0 absorbable suture. | Procedure or surgery | Laparoscopic Excision of Large Cesarean Scar Niche |
| Combined hysteroscopic and laparoscopic repair of cesarean scar nicheAlso: Combined hysteroscopic and laparoscopic repair without excision of large cesarean scar nicheHysteroscopic resection of the niche under laparoscopic guide will be done to avoid perforation of the niche. After completion of the hysteroscopic approach, laparoscopic plication of the niche without opening it will be done using multiple interrupted 2-0 absorbable suture. | Procedure or surgery | Combined Hysteroscopic and Laparoscopic Repair without Excision of Large Cesarean Scar Niche |
Primary outcome
change of the residual myometrium thickness
Time frame: will be measured at the 3-month and 6-month
ultrasound measurement of the residual myometrium will be done
reduction of postmenstrual bleeding
Time frame: will be assessed at the 3-month and 6-month
participants will report their perception of the amount of bleeding using a questionnaire
1 secondary outcome
Subsequent fertility outcome
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
- BackgroundAlmarzuki, U. H., Ahmed, T. A. F., AlBehedy, T. M., et al. (2022). Evaluation of Anatomical Characteristics of Cesarean Scar Niche by Sonohysterography and Diagnostic Hysteroscopy in Women with Secondary Infertility. The Egyptian Journal of Hospital Medicine, 88(1), 2904-2909.
- Background: PubMed 28356813Bakaviciute G, Spiliauskaite S, Meskauskiene A, Ramasauskaite D. Laparoscopic repair of the uterine scar defect - successful treatment of secondary infertility: a case report and literature review. Acta Med Litu. 2016;23(4):227-231. doi: 10.6001/actamedica.v23i4.3424.
- Background: PubMed 26849801Betran AP, Ye J, Moller AB, Zhang J, Gulmezoglu AM, Torloni MR. The Increasing Trend in Caesarean Section Rates: Global, Regional and National Estimates: 1990-2014. PLoS One. 2016 Feb 5;11(2):e0148343. doi: 10.1371/journal.pone.0148343. eCollection 2016.
- Background: PubMed 23996650Bij de Vaate AJ, van der Voet LF, Naji O, Witmer M, Veersema S, Brolmann HA, Bourne T, Huirne JA. Prevalence, potential risk factors for development and symptoms related to the presence of uterine niches following Cesarean section: systematic review. Ultrasound Obstet Gynecol. 2014 Apr;43(4):372-82. doi: 10.1002/uog.13199.
- Background: PubMed 27816234Donnez O, Donnez J, Orellana R, Dolmans MM. Gynecological and obstetrical outcomes after laparoscopic repair of a cesarean scar defect in a series of 38 women. Fertil Steril. 2017 Jan;107(1):289-296.e2. doi: 10.1016/j.fertnstert.2016.09.033. Epub 2016 Nov 2.
- Background: PubMed 31984814Cohen SB, Bouaziz J, Bar On A, Orvieto R. Fertility success rates in patients with secondary infertility and symptomatic cesarean scar niche undergoing hysteroscopic niche resection. Gynecol Endocrinol. 2020 Oct;36(10):912-916. doi: 10.1080/09513590.2020.1716327. Epub 2020 Jan 27.
- Background: PubMed 29536581Jordans IPM, de Leeuw RA, Stegwee SI, Amso NN, Barri-Soldevila PN, van den Bosch T, Bourne T, Brolmann HAM, Donnez O, Dueholm M, Hehenkamp WJK, Jastrow N, Jurkovic D, Mashiach R, Naji O, Streuli I, Timmerman D, van der Voet LF, Huirne JAF. Sonographic examination of uterine niche in non-pregnant women: a modified Delphi procedure. Ultrasound Obstet Gynecol. 2019 Jan;53(1):107-115. doi: 10.1002/uog.19049.
- Background: PubMed 31845165Stegwee SI, Beij A, de Leeuw RA, Mokkink LB, van der Voet LF, Huirne JAF. Niche-related outcomes after caesarean section and quality of life: a focus group study and review of literature. Qual Life Res. 2020 Apr;29(4):1013-1025. doi: 10.1007/s11136-019-02376-6. Epub 2019 Dec 16.
- Background: PubMed 28703935Vervoort A, Vissers J, Hehenkamp W, Brolmann H, Huirne J. The effect of laparoscopic resection of large niches in the uterine caesarean scar on symptoms, ultrasound findings and quality of life: a prospective cohort study. BJOG. 2018 Feb;125(3):317-325. doi: 10.1111/1471-0528.14822. Epub 2017 Aug 28.
- Background: PubMed 35014923Vrijdaghs V, Dewilde K, Froyman W, Van den Bosch T. Hysteroscopic management of caesarean scar defects. J Obstet Gynaecol. 2022 Jul;42(5):816-822. doi: 10.1080/01443615.2021.2003310. Epub 2022 Jan 11.
- Individual participant dataSharing planned: Undecided. data may be used for another study
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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 laparoscopic repair of cesarean scar niche and Combined hysteroscopic and laparoscopic repair of cesarean scar niche in people with Cesarean Scar Niche, run by Zagazig 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 5 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 21 Mar 2023. 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 Mahmoud Abubakr Nasr Negm, lecturer of Obs & Gyne (20122 887 4439, mahmoudabubakrnegm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of the residual myometrium thickness (time frame: will be measured at the 3-month and 6-month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05777837, which also lists 10 linked publications.
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 21 Mar 2023.