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

NCT03176992 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2017-06-06

No results posted yet for this study

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

Conditions

  • Endometrial Hyperplasia

Interventions

DRUG

SURGICEL®

insertion of 4 pieces of Surgicel inside the uterine cavity after formal curettage

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • MOUTAZ ELSHERBINI, MD · Assistant professor of obstetrics and gynecology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2017-12-31
Completion
2018-02-28

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03176992 on ClinicalTrials.gov