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Intrauterine Balloon Dilatation Therapy in the Prevention of Adhesion Formation After Hysteroscopic Myomectomy

NCT03169478 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2017-06-07

No results posted yet for this study

Summary

Transcervical resection of submucous myomas (TCRM) is nowadays considered necessary if it is associated with infertility or miscarriage or menorrhagia. Nevertheless, one possible risk of hysteroscopic myomectomy is the formation of intrauterine adhesion (IUA) at the site of resection. The development of IUA arising from trauma to the basalis layer of the endometrium during hysteroscopy can result in infertility, recurrent miscarriages, amenorrhea, dysmenorrhea, or abnormal placentation.

Several measures have been proposed in an effort to decrease the formation of post-surgical intrauterine adhesions. Additionally, physical barriers such as balloon catheters or intrauterine devices have been used in the postoperative period. Despite years of studies evaluating prevention strategies for intrauterine adhesion formation after operative hysteroscopy, it is still unclear which strategy is most effective because there has never been any formal properly powered randomized, control trial to examine the efficacy of the various methods used to prevent adhesion reformation.

In this prospective, randomized, controlled study, the investigators wish to examine the efficacy of intrauterine balloon dilatation therapy in the early postoperative period in preventing adhesion formation after transcervical resection of submucous myomas.

Conditions

  • Intrauterine Adhesion

Interventions

PROCEDURE

multiple myoma IUB dilatation group

A Foley catheter (size 8-12fr) will be prepared by cutting the excess catheter tip protruding beyond the balloon. Once the catheter has reached the fundus, 3-5mls of saline will be slowly introduced into the balloon under ultrasound guidance, in order to directly visualize the distention of the cavity and stretching and blunt dissection of any intrauterine adhesions, if present.

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
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-05-30
Primary Completion
2019-05-30
Completion
2019-07-31

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 NCT03169478 on ClinicalTrials.gov