NCT03176992

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 6, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

June 6, 2017

Status Verified

June 1, 2017

Enrollment Period

2.5 years

First QC Date

June 2, 2017

Last Update Submit

June 5, 2017

Conditions

Endometrial Hyperplasia

Keywords

ablationsurgicel

Outcome Measures

Primary Outcomes (1)

  • amenorrhea rates

    absence of menstruation

    18 months

Secondary Outcomes (4)

  • PBAC score (pictorial blood loss assessment chart score)

    18 months

  • dysmenorrhea rates

    18 months

  • patient satisfaction

    18 months

  • the need for re-intervention

    18 months

Study Arms (3)

Surgicel group

ACTIVE COMPARATOR

80 patients underwent formal curettage followed by insertion of 4 pieces of Surgicel inside the uterine cavity

Drug: SURGICEL®

Thermal balloon ablation group

NO INTERVENTION

80 patients underwent thermal balloon ablation using bipolar radiofrequency electrical energy (Novasure)

Endometrial resection group

NO INTERVENTION

80 patients underwent transcervical Hysteroscopic endometrial resection

Interventions

SURGICEL®DRUG

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

Surgicel group

Eligibility Criteria

Age40 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

kasr elaini hospital (Cairo university)

Cairo, 115431, Egypt

RECRUITING

MeSH Terms

Conditions

Endometrial Hyperplasia

Interventions

Surgicel

Condition Hierarchy (Ancestors)

Uterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • MOUTAZ ELSHERBINI, MD

    Assistant professor of obstetrics and gynecology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

MOUTAZ ELSHERBINI, MD

CONTACT

(+20)01001588300mizosherbini@yahoo.com

FADEL SHALTOUT, MD

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

June 2, 2017

First Posted

June 6, 2017

Study Start

June 1, 2015

Primary Completion

December 1, 2017

Study Completion

February 1, 2018

Last Updated

June 6, 2017

Record last verified: 2017-06

Locations

EG(1)