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Intrauterine Balloon and Postoperative Estrogen Therapy in the Prevention of Adhesion Reformation After Hysteroscopic Adhesiolysis

NCT02617108 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 310

Last updated 2019-10-02

No results posted yet for this study

Summary

Patients who want to go TCRS will randomly divided 3 groups. In Group 1(100 patients), women received postoperative estrogen therapy. In Group 2 (100 patients), a Foley catheter with the balloon inflated with 4 ml of normal saline solution will be placed into the uterine cavity at the end of the operation for five days. In Group 3 (110 patients), women will not receive any of the treatment (comparison group). All subjects underwent two further hysteroscopy, one and three months after the initial surgery. At the second or third look hysteroscopy, the incidence of intra-uterine adhesion will be analyzed.

Conditions

  • Uterine Septum

Interventions

DEVICE

Foley balloon

a Foley balloon with 4 ml of normal saline solution will be placed into the uterine cavity at the end of the operation for five days.

Sponsors & Collaborators

  • Fu Xing Hospital, Capital Medical University

    lead OTHER

Principal Investigators

  • Tinchiu Li, Ph.D. · Chinese University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-31
Primary Completion
2021-11-30
Completion
2021-11-30

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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 NCT02617108 on ClinicalTrials.gov