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

Status Recruiting

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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Cesarean Scar Niche

• NCT number: NCT05777837
• Study type: Interventional
• Source: Zagazig University
• Contact: Mahmoud Abubakr Nasr Negm, lecturer of Obs & Gyne
• Phone: 20122 887 4439
• Email: mahmoudabubakrnegm@gmail.com
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Completion date: May 1, 2024