RecruitingACTRN12625001008415

Effectiveness of hysteroscopic resection of a niche VERSUS Expectant management in women with premenstrual spotting postmenstrual spotting

Effectiveness of hysteroscopic resection of a niche VERSUS Expectant management in women with premenstrual spotting , A randomized controlled trial. .


Sponsor

Maternity and children hospital faculty of medicine Minia University

Enrollment

110 participants

Start Date

Sep 28, 2025

Study Type

Interventional

Conditions

Summary

efficacy of hystroscpic resection of cesarean section niche for management purpose to improve post menstrual spotting .


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 45 Yearss

Plain Language Summary

Simplified for easier understanding

A caesarean scar niche (also called an isthmocele) is a small indentation or defect that can develop at the site of a caesarean section scar inside the uterus. It is a common cause of postmenstrual spotting — light bleeding or brown discharge that occurs after a period has otherwise ended. While this symptom can be frustrating and affect quality of life, it is not always clear whether treatment is necessary. This randomised controlled trial directly compares two approaches: hysteroscopic surgical repair of the niche (a minimally invasive procedure using a camera and instruments passed through the vagina and cervix) versus watchful waiting (expectant management). Participants will be randomly assigned to undergo the hysteroscopic resection procedure or to be monitored without intervention over the study period. Researchers will track whether postmenstrual spotting resolves or improves, and compare outcomes between the two groups. You may be eligible if you are a woman aged 18–45 with at least one previous caesarean delivery, a confirmed uterine niche on ultrasound, and postmenstrual spotting lasting more than two days per cycle with otherwise regular periods. People with an active pelvic infection, known clotting disorders, an IUD in place, or other identifiable causes of abnormal uterine bleeding (such as fibroids or polyps) would not be eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

General or regional (spinal) anesthesia depending on the extent of the procedure and surgeon preference. duration of the intervention : 30 -60 minutes . surgeon : senior specialist of endoscopic su

General or regional (spinal) anesthesia depending on the extent of the procedure and surgeon preference. duration of the intervention : 30 -60 minutes . surgeon : senior specialist of endoscopic surgery. *Positioning: Lithotomy position with appropriate padding to avoid nerve injury. Bladder should be emptied before the procedure. 3. Surgical Equipment: *Rigid hysteroscope (5–9 mm) with operative channel. *30° lens for better visualization. *Electrosurgical loop momopolar or bipolar resectoscope . *Uterine distension medium (normal saline for bipolar or glycine for monopolar energy). *Cervical dilators, if necessary. *Fluid management system to monitor inflow and outflow.Cervical Dilation (if required): Gradual dilation up to size compatible with the resectoscope. 2. Diagnostic Hysteroscopy: Initial inspection of uterine cavity to locate the cesarean scar defect, usually found at the anterior lower uterine segment. 4. Identification of Niche: Appears as a pouch or depression at the scar site, often with retained blood or mucus. 5. Resection Steps: a. Resect the Inferior Edge: Use a bipolar loop or scissors to excise the fibrotic and overhanging inferior edge of the niche to improve drainage and eliminate the pocket. *Remove any granulation tissue or polypoidal growth inside the niche. *Avoid aggressive resection of the superior edge to minimize thinning of the overlying myometrium. c. Coagulation: Apply light coagulation to bleeding points, avoiding excessive energy near the uterine serosa. 6.Fluid Balance Monitoring: Monitor input and output of distension fluid to avoid fluid overload (especially with glycine). strategies to assess the adherence to the intervention is accurate record of operative notes.


Locations(1)

Egypt

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ACTRN12625001008415