The Efficacy of Intrauterine Balloon Dilatation Therapy in the Prevention of Adhesion Formation After Hysteroscopicremovalof Multiple Fibroids
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 112
- Locations
- 1
- Primary Endpoint
- The amount of intrauterine adhesions at second look hysteroscopy
Study Overview
Brief 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.
Detailed Description
Objectives
To investigate the efficacy of intrauterine balloon (IUB) dilatation therapy in the prevention of adhesion formation after transcervical resection of submucous myomas (TCRM).
Patients
The patients will be recruited from two centers, namely, the Hysterscopy Center of the Fuxing Hospital and TianTan Hospital, Capital Medical University, Beijing, China. Before the surgery all patients with suspected submucous myomas will undergo preoperative evaluations including trans-vaginal ultrasonography. The inclusion criteria include [1] women aged 18-45 years with regular 25-35 days cycles ; [2] no evidence of intrauterine adhesions at the time of surgery; [3] written consent obtained; and [4] agreement to have second-look hysteroscopy; [5] had more than one fibroids removed at the time of hysteroscopic surgery. The exclusion criteria include women who are already postmenopausal or women who have evidence of intrauterine adhesions at the time of surgery.
Study Design
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •[1] women aged 18-45 years with regular 25-35 days cycles ;
- •[2] no evidence of intrauterine adhesions at the time of surgery;
- •[3] written consent obtained;
- •[4] agreement to have second-look hysteroscopy;
- •[5] had more than one fibroids removed at the time of hysteroscopic surgery
Exclusion Criteria
- •[1] women who are already postmenopausal
- •[2] women who have evidence of intrauterine adhesions at the time of surgeryare
Arms & Interventions
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.
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.
Intervention: multiple myoma IUB dilatation group (Procedure)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- menstrual pattern(at 3 months post-op)
- complications of hysteroscopic myomectomy(at 6 weeks post-op)
Investigators
Xiaoyu Shi
Principal Investigator
Fu Xing Hospital, Capital Medical University