Clinical Presentations and Surgical Outcome of Obstructive Müllerian Anomalies

Recruiting

• Conditions: Mullerian Duct Anomalies

• Registration Number: NCT06110052
• Lead Sponsor: Assiut University

Brief Summary

The present study aims at:

A. The main outcome is to compare preoperative and postoperative visual analog scale VAS from 0 to 10 of maximum perceived pain in ladies with OMAs.

1. description of clinical presentation and percentage of OMAs in relation to other Mullerian anomalies

2. description of different subtypes and its percentage.

3. description of the corrective procedures and their short-term outcomes.

Detailed Description

Obstructive Mullerian anomalies (OMAs) represent a real challenge in diagnosis and treatment, its incidence is not yet recognized. Care givers and gynecologist should be aware with its clinical presentation to avoid its delayed diagnosis and misdiagnosis. In addition, delayed diagnoses may result in retrograde menstruation, recurrent cyclic pains, chronic pelvic pains, poor quality of life and threats to future fertility.

Cases with complete obstructive Müllerian anomalies (C-OMAs) classically present with recurrent cyclic pains at puberty and their diagnosis is usually established easily. However, cases with Hemi obstructive anomalies (H-OMA) usually present with progressive dysmenorrhea and delayed diagnosis may result in pelvic adhesions, progressive hematosalpinx and endometriosis which directly threats natural future fertility. H-OMAs may results from obstructing uterine septa or unilateral cervical obstruction in a double uterus. Also, it may result from obstructing longitudinal vaginal septa in cases with double uterus, septate uterus or hybrid septate uterus .

A hybrid uterine anomaly is relatively a recent term that described the coexistence of septate and bicornuate uterus together. Pure septate uterus has a convex or flat fundus, when there is any fundal depression, it is termed hybrid septate uterus.

Pain with or without amenorrhoea is the main presentation of OMAs. Surgical correction should improve these symptoms. To the best of our knowledge there is no published prospective trials compared visual analog scale VAS in ladies with OMAs before and after surgical correction.

Study Timeline

• Study Start: 2022-12-01
• Primary Completion: 2023-08-01
• Study First Submitted: 2023-08-03
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-30
• Last Update Submitted: 2023-10-30
• Study First Posted: 2023-10-31
• Last Update Posted: 2023-10-31
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 36

Inclusion Criteria

• All cases with OMAs or H-OMAs

Exclusion Criteria

• Cases who refuse to participate in the study. 2.Cases who underwent previous surgical repair for their OMA or H-OMA.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
mullerian duct anomalies	48 months	A. The main outcome is to compare preoperative and postoperative visual analog scale VAS of maximum perceived pain in ladies with OMAs.

Trial Locations

Locations (1)

Assiut Medical School; 🇪🇬 Assiut, Egypt