UnknownNot Applicable

Laparoscopic Versus Combined Laparoscopic and Hysteroscopic Repair of CS Niche

Egypt30 participantsStarted 2023-04-01

Plain-language 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.

Who can participate

Age range18 Years – 40 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

change of the residual myometrium thickness

Timeframe: will be measured at the 3-month and 6-month

reduction of postmenstrual bleeding

Timeframe: will be assessed at the 3-month and 6-month

Trial details

NCT IDNCT05777837

SponsorZagazig University

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2024-04-01

Contact for this trial

Mahmoud Abubakr Nasr Negm, lecturer of Obs & Gyne

20122 887 4439 mahmoudabubakrnegm@gmail.com