Immediate and Delayed Intrauterine Balloon in the Prevention of Adhesion Reformation After Hysteroscopic Adhesiolysis
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|ClinicalTrials.gov Identifier: NCT03171454|
Recruitment Status : Unknown
Verified June 2017 by Xiaoyu Shi, Fu Xing Hospital, Capital Medical University.
Recruitment status was: Recruiting
First Posted : May 31, 2017
Last Update Posted : June 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Intrauterine Adhesion||Procedure: Delayed Intrauterine Balloon therapy Procedure: immediate Intrauterine Balloon therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Randomized, Controlled Trial Comparing Immediate and Delayed Intrauterine Balloon Therapy in the Prevention of Adhesion Reformation After Hysteroscopic Adhesiolysis|
|Actual Study Start Date :||May 30, 2017|
|Estimated Primary Completion Date :||September 30, 2018|
|Estimated Study Completion Date :||December 31, 2018|
Experimental: Delayed Intrauterine Balloon therapy
In the delayed balloon group,a Foley catheter will be inserted into the uterine cavity 2 weeks after the surgery, the balloon will be inflated with normal saline (from 3ml to 5ml) then deflated, and the procedure repeated three time over 3 minutes or so, then the cavity will be flushed with 10 mls of normal saline solution after via the irrigating channel of the Foley catheter before removal. The whole procedure will be repeated a further 2 weeks later.
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.
Experimental: 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 5mls of saline under ultrasound guidance and the balloon will stay in situ for 7 days.
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.
- AFS score [ Time Frame: at 6 weeks post-op ]The degree of intrauterine adhesions described by AFS score reduction at second look hysteroscopy
- The menstrual pattern [ Time Frame: at 6 weeks post-op ]Menstrual blood loss figure before and after surgery
- infection rate [ Time Frame: at 6 weeks post-op ]Secretion bacteria culture
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): NCT03171454
|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|