Surgicel® & Endometrial Ablation in the Management of Perimenpausal Heavy Menstrual Bleeding

• Status: Unknown status
• Trial end date: 2018-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

Two hundred & forty patients aged from 40 to 50 years - complaining of heavy menstrual bleeding that is unresponsive to hormonal lines of treatment & requesting conservative surgical approach- were randomized into 3 groups; group A (Surgicel group) in which 80 patients underwent formal curettage followed by insertion of 4 pieces of Surgicel inside the uterine cavity, group B (Thermal balloon ablation group) in which 80 patients underwent thermal balloon ablation using bipolar radiofrequency electrical energy (Novasure), group C (Endometrial resection group) in which 80 patients underwent transcervical Hysteroscopic endometrial resection.All patients were followed up over duration of 18 months following the procedure (at 3,6,12 & 18 months). Primary outcome included amenorrhea rates

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Cairo University

Criteria

Inclusion Criteria:

• Heavy menstrual bleeding (i.e. pictorial blood loss assessment chart score >150) that unresponsive to hormonal lines of treatment & requesting conservative surgical approach.

• Uterine length <12 cm.

• FSH level > 40 IU/L

• Normal Pap smear

• Benign endometrial pathology

Exclusion Criteria:

• Active form of PID

• Uterine scars & uterine malformation.

• Uterine organic lesions (e.g., fibroids, polyps & Adenomyosis)

• Previous history of endometrial ablation.

• Patients seeking fertility preservation.

• Patients suffering coagulopathies or receiving anticoagulant treatments