Laparoscopic Versus Transvaginal Approaches in Repair of Uterine Niche: A Randomized Controlled Trial (isthmocele)
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|ClinicalTrials.gov Identifier: NCT04241107|
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : February 5, 2020
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)
|Condition or disease||Intervention/treatment||Phase|
|Uterine Niche||Procedure: Laparoscopic repair of Uterine niche Procedure: Transvaginal repair of Uterine niche||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Laparoscopic Versus Transvaginal Approaches in Repair of Uterine Niche: A Randomized Controlled Trial|
|Estimated Study Start Date :||March 2020|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||March 2022|
Active Comparator: Laparoscopic approach group(A)
Uterine niche will be repaired through Laparoscopic approach.
Procedure: Laparoscopic repair of Uterine niche
Repair of uterine niche through Laparoscopic approach.
Active Comparator: Transvaginal approach group(B)
Uterine niche will be repaired through Transvaginal approach.
Procedure: Transvaginal repair of Uterine niche
Repair of uterine niche through Transvaginal approach.
- Clinical efficacy [ Time Frame: 3 month postoperative ]Number of patients who subject clinical improvement of pre-operative symptoms
- Post-operative increase in residual myometrial thickness [ Time Frame: 3 month postoperative ]difference between pre-operative & post-operative residual myometrial thickness
- Duration of operation [ Time Frame: baseline( During operation) ]duration from anesthesia till end of operation
- Blood loss [ Time Frame: baseline( During operation) ]estimated blood loss during operation(towels , suction container)
- Intra-operative complication [ Time Frame: baseline( During operation) ]complication during the operation
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04241107
|Contact: Abdulrahman Muhammad Rageh, M.Sc||02 01005056259||Abdulrahmanrageh.firstname.lastname@example.org|
|Abdulrahman Muhammad Rageh||Recruiting|
|Assiut, Egypt, 71111|
|Contact: Abdulrahman Muhammad Rageh, MSc +201005056259 Abdulrahmanrageh.email@example.com|
|Study Chair:||Mahmoud Abdel-Aleem, PhD||Assiut University|
|Study Chair:||Mahmoud zakhera, PhD||Assiut University|
|Study Chair:||Ahmed Abo El Fadle, MD||Assiut University|