Pre-Surgical Grading System of Asherman Syndrome

• Sponsor: Ebtesama Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT05901948
• Collaborator: (none)
• Enrollment: 65
• Location: 1
• Actual Duration (Months): 38.2
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

Utilising a novel pre-surgical grading system to class cases of asherman syndrome into 3 groups based on expected difficulty of surgery and potential prognostic outcomes.

Condition or Disease	Intervention/Treatment	Phase
Asherman Syndrome	Other: Classification

Detailed Description

Using the grading system, patients are classified into Mild, Moderate and Severe Asherman Syndrome. With the mild disease having the best prognostic value and a 1 step procedure, Moderate cases having a mediocre prognosis and usually multi-step procedure and Severe cases having a poor prognosis and counseled to other options. This observational study looks at the surgical outcomes following hysteroscopy for cases graded according to the new system to identify the accuracy of the classification in predicting the surgical success and prognostic value.

Study Design

• Study Type: Observational
• Actual Enrollment: 65 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Asherman Syndrome: Pre-surgical Grading to Improve Gauge Prognostic Values and Improve Outcomes
• Actual Study Start Date: Jan 7, 2020
• Actual Primary Completion Date: Jan 31, 2023
• Actual Study Completion Date: Mar 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Asherman Patients Patients diagnosed with Asherman syndrome based on patient complaint of hypomenorrhea or amenorrhea and hysterosalpingography.	Other: Classification; Novel Asherman Scoring Classification

Outcome Measures

Primary Outcome Measures

1. Percentage Resumption of normal cavity on hystero-salpingography [1 month]

   assessing the improvement of the cavity of the uterus in hystero-salpingography

Secondary Outcome Measures

1. Menses [3 months]

   Improvement in patients menstrual cycle

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Asherman Syndrome

• intra-uterine synechiae

Exclusion Criteria:

• patients with a fundectomy or uterine reduction surgery.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ebtesama Hospital	Cairo		Egypt	11341

Sponsors and Collaborators

• Ebtesama Hospital

Investigators

• Study Chair: Osama Shawki, MD, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yehia Shawki, Endoscopy unit director, Ebtesama Hospital
• ClinicalTrials.gov Identifier: NCT05901948
• Other Study ID Numbers: 100032023002
• First Posted: Jun 13, 2023
• Last Update Posted: Jun 13, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Yehia Shawki, Endoscopy unit director, Ebtesama Hospital: Asherman Syndrome; Hysteroscopy; Intra-Uterine Surgery; Intra-Uterine Adhesions; Classification
• Additional relevant MeSH terms: Gynatresia; Syndrome

Study Results

No Results Posted as of Jun 13, 2023