Laparoscopic Versus Combined Laparoscopic and Hysteroscopic Repair of CS Niche

Cesarean Scar Niche Clinical Trial

Official title:

Laparoscopic Excision Versus Combined Hysteroscopic and Laparoscopic Repair Without Excision of Large Cesarean Scar Niche: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05777837
• Other study ID #: CS scar niche repair
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: May 1, 2024

Study information

• Verified date: March 2023
• Source: Zagazig University
• Contact: Mahmoud Abubakr Nasr Negm, lecturer of Obs & Gyne
• Phone: 20122 887 4439
• Email: mahmoudabubakrnegm[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Related Conditions & MeSH terms

• Cesarean Scar Niche

Intervention

Procedure:
• laparoscopic repair 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 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.

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Zagazig City

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

References & Publications (10)

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. — View Citation

Betran 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. — View Citation

Bij 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. — View Citation

Cohen 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. — View Citation

Donnez 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. — View Citation

Jordans 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. — View Citation

Stegwee 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. — View Citation

Vervoort 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. — View Citation

Vrijdaghs 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of the residual myometrium thickness	ultrasound measurement of the residual myometrium will be done	will be measured at the 3-month and 6-month
Primary	reduction of postmenstrual bleeding	participants will report their perception of the amount of bleeding using a questionnaire	will be assessed at the 3-month and 6-month
Secondary	Subsequent fertility outcome	the incidence of subsequent conception following intervention will be recorded	1 year