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Immediate and Delayed Intrauterine Balloon in the Prevention of Adhesion Reformation After Hysteroscopic Adhesiolysis

NCT03171454 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2017-06-07

No results posted yet for this study

Summary

In this prospective, randomized, controlled study, the investigators wish to compare the efficacy of immediate and delayed intrauterine balloon (IUB) therapy in the prevention of adhesion reformation after hysteroscopic adhesiolysis.

Conditions

  • Intrauterine Adhesion

Interventions

PROCEDURE

Delayed Intrauterine Balloon therapy

D-IUB dilatation therapy group will be performed using a (size 12-14fr) Foley catheter and according to the methodology published in the literature. This will be prepared by cutting the catheter tip protruding beyond the balloon. Once the catheter has reached the fundus, 5mls of saline will be slowly instilled into the balloon under ultrasound guidance.

PROCEDURE

immediate Intrauterine Balloon therapy

At the conclusion of the surgery, in the immediate balloon group: a Foley-catheter will be immediately inserted into the uterine cavity and the balloon will be distended with 4-5mls of saline under ultrasound guidance and the balloon will stay in situ for 7 days.

Sponsors & Collaborators

  • Beijing Tiantan Hospital

    collaborator OTHER

  • Fu Xing Hospital, Capital Medical University

    lead OTHER

Principal Investigators

  • Tinchiu Li · Fu Xing Hospital, Capital Medical University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-05-30
Primary Completion
2018-09-30
Completion
2018-12-31

Countries

  • China

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 NCT03171454 on ClinicalTrials.gov