Laparoscopic Versus Combined Laparoscopic and Hysteroscopic Repair of CS Niche

NCT05777837 | Unknown

• 1 other identifier: CS scar niche repair
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cesarean Scar Niche

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Subsequent fertility outcome

  1 year

Study Arms (2)

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

Interventions

laparoscopic repair of cesarean scar niche PROCEDURE

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.

Also known as: laparoscopic excision of cesarean scar niche

Laparoscopic Excision of Large Cesarean Scar Niche

Combined hysteroscopic and laparoscopic repair of cesarean scar niche PROCEDURE

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.

Also known as: Combined hysteroscopic and laparoscopic repair without excision of large cesarean scar niche

Combined Hysteroscopic and Laparoscopic Repair without Excision of Large Cesarean Scar Niche

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Faculty of Medicine

Zagazig, Egypt

RECRUITING

Related 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.

  BACKGROUND

• 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.

  PMID: 28356813 BACKGROUND

• 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.

  PMID: 26849801 BACKGROUND

• 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.

  PMID: 23996650 BACKGROUND

• 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.

  PMID: 27816234 BACKGROUND

• 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.

  PMID: 31984814 BACKGROUND

• 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.

  PMID: 29536581 BACKGROUND

• 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.

  PMID: 31845165 BACKGROUND

• 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.

  PMID: 28703935 BACKGROUND

• 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.

  PMID: 35014923 BACKGROUND

Central Study Contacts

Mahmoud Abubakr Nasr Negm, lecturer of Obs & Gyne

CONTACT

20122 887 4439; mahmoudabubakrnegm@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of Obstetrics and gynecology

Study Record Dates

• First Submitted: February 25, 2023
• First Posted: March 21, 2023
• Study Start: April 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: May 1, 2024
• Last Updated: March 21, 2023

Record last verified: 2023-03

Locations

EG (1)