Clinical trial NCT06110052: Clinical Presentations and Surgical Outcome of Obstructive Müllerian Anomalies
Official title: Clinical Presentations and Surgical Outcome of Obstructive Müllerian Anomalies: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mullerian Duct Anomalies
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-10-31
Enrollment: 36
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: demographic data will be collected about age, marital status, menarche, parity, consanguinity and family history.

detailed history: about complaint and presenting symptoms will be obtained as delayed menarche, cyclic pain, abdominal distention, dull aching abdominal pain, dyspareunia and infertility physical examination:

* general examination for secondary sexual characters, other anomalies
* abdominal examination for abdominal mass, tenderness
* genital examination by inspection for bulging hymen, per-vaginal examination
* per- rectal examination investigation : CBC,, transvaginal, per-rectal, 3D abdominal ultrasonography

Diagnosis:

Anomalies will be categorized according to ESHRE classification 2016 Surgical procedure: follow up for the patient for three months for symptoms improvement and any complications.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: mullerian duct anomalies
timeFrame: 48 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut Medical School
Study officials:
affiliation: Assiut medical school
name: Ahmed F Amin, professor
role: STUDY_CHAIR
References:
citation: El Saman AM. Combined retropubic balloon vaginoplasty and laparoscopic canalization: a novel blend of techniques provides a minimally invasive treatment for cervicovaginal aplasia. Am J Obstet Gynecol. 2009 Sep;201(3):333.e1-5. doi: 10.1016/j.ajog.2009.07.001.
citation: El Saman AM. Endoscopically monitored canalization for treatment of congenital cervical atresia: the least invasive approach. Fertil Steril. 2010 Jun;94(1):313-6. doi: 10.1016/j.fertnstert.2009.02.079. Epub 2009 May 21.
citation: Fedele L, Bianchi S, Frontino G, Berlanda N, Montefusco S, Borruto F. Laparoscopically assisted uterovestibular anastomosis in patients with uterine cervix atresia and vaginal aplasia. Fertil Steril. 2008 Jan;89(1):212-6. doi: 10.1016/j.fertnstert.2007.01.168. Epub 2007 May 4.
citation: Li M, Zhang Z. Laparoscopically assisted biomaterial graft for reconstruction in congenital atresia of vagina and cervix. Fertil Steril. 2013 Dec;100(6):1784-7. doi: 10.1016/j.fertnstert.2013.08.046. Epub 2013 Sep 29.
citation: El Saman AM, Shahin AY, Nasr A, Tawfik RM, Saadeldeen HS, Othman ER, Habib DM, Abdel-Aleem MA. Hybrid septate uterus, coexistence of bicornuate and septate varieties: a genuine report. J Obstet Gynaecol Res. 2012 Nov;38(11):1308-14. doi: 10.1111/j.1447-0756.2012.01866.x. Epub 2012 May 21.
citation: El Saman AM, Nasr A, Tawfik RM, Saadeldeen HS. Mullerian duct anomalies: successful endoscopic management of a hybrid bicornuate/septate variety. J Pediatr Adolesc Gynecol. 2011 Aug;24(4):e89-92. doi: 10.1016/j.jpag.2011.02.013. Epub 2011 Apr 21.
citation: Ozbey H, Morozov D, Morozov DA. Abdominal pain as the presentation of imperforate hymen in a teenage girl. Pediatr Int. 2022 Jan;64(1):e15168. doi: 10.1111/ped.15168. No abstract available.
citation: Rozalska B, Sakata N, Wadstrom T. Staphylococcus aureus fibronectin-binding proteins (FnBPs). Identification of antigenic epitopes using polyclonal antibodies. APMIS. 1994 Feb;102(2):112-8.