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

NCT04241107 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-02-05

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Principal Investigators

  • Mahmoud Abdel-Aleem, PhD · Assiut University

  • Mahmoud zakhera, PhD · Assiut University

  • Ahmed Abo El Fadle, MD · Assiut University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
43 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-31
Primary Completion
2021-12-31
Completion
2022-03-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04241107 on ClinicalTrials.gov