NCT04241107

Laparoscopic Versus Transvaginal Approaches in Repair of Uterine Niche: A Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: Female
• Age: 20 Years – 43 Years
• Healthy volunteers: Not accepted

Summary

The treatment of uterine niche ranges from clinical management with expectant or pharmacological treatment, surgical treatment. Approaches for repair include Laparotomy, laparoscopy , hysteroscopy , vaginal. The decision to treat takes into consideration the size of the defect, presence of symptoms, secondary infertility and plans of pregnancy. All of the approaches have its merits and debates. There is ongoing debate regarding the best surgical approach to managing this condition. To date no randomized controlled trials have been published to settle this debate. Our study aim is to to evaluate which surgical approach is a preferable option, this study will be conducted to compare the Laparoscopic and transvaginal approaches in several regards, including, operation time, blood loss, perioperative complications, hospital stay length, postoperative increase in residual myometrial thickness during follow-up , clinical efficacy(percentage of patients who subject improvement of symptoms)

Conditions

• Uterine Niche

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic repair of Uterine niche	Repair of uterine niche through Laparoscopic approach.
PROCEDURE	Transvaginal repair of Uterine niche	Repair of uterine niche through Transvaginal approach.

Timeline

• Start date: 2020-03-01
• Primary completion: 2021-12-01
• Completion: 2022-03-01
• First posted: 2020-01-27
• Last updated: 2020-02-05

Locations

1 site across 1 country: Egypt