Intrauterine Balloon Dilatation Therapy in the Prevention of Adhesion Formation After Hysteroscopic Myomectomy
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|ClinicalTrials.gov Identifier: NCT03169478|
Recruitment Status : Unknown
Verified June 2017 by Xiaoyu Shi, Fu Xing Hospital, Capital Medical University.
Recruitment status was: Recruiting
First Posted : May 30, 2017
Last Update Posted : June 7, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Intrauterine Adhesion||Procedure: multiple myoma IUB dilatation group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||112 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Efficacy of Intrauterine Balloon Dilatation Therapy in the Prevention of Adhesion Formation After Hysteroscopicremovalof Multiple Fibroids|
|Actual Study Start Date :||May 30, 2017|
|Estimated Primary Completion Date :||May 30, 2019|
|Estimated Study Completion Date :||July 31, 2019|
No Intervention: multiple myoma control group
The control group will not have any balloon therapy. A second-look hysteroscopy will be carried out 6 weeks after the surgery.
Experimental: multiple myoma IUB dilatation group
The multiple myoma study group will have Foley-catheter intrauterine balloon dilatation therapy 2 weeks and 4 weeks after hysteroscopic myomectomy. A second-look hysteroscopy will be carried out 6 weeks after the surgery.
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.
- The amount of intrauterine adhesions at second look hysteroscopy [ Time Frame: at 6 weeks post-op ]The amount of intrauterine adhesions according to AFS score at second look hysteroscopy
- complications of hysteroscopic myomectomy [ Time Frame: at 6 weeks post-op ]complications of hysteroscopic myomectomy including infection rate
- menstrual pattern [ Time Frame: at 3 months post-op ]The menstrual pattern before and after surgery and the need for re-operation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03169478
|Contact: Lei Guo||+86 firstname.lastname@example.org|
|Contact: Tinchiu Li||+86 010 email@example.com|
|Study Chair:||Tinchiu Li||Fu Xing Hospital, Capital Medical University|