Intrauterine Adhesion Clinical Trial
Official title:
The Efficacy of Intrauterine Balloon Dilatation Therapy in the Prevention of Adhesion Formation After Hysteroscopicremovalof Multiple Fibroids
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.
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
After the completion of transcervical resection of submucous myomas (TCRM), recruited
patients will be randomized to one of the two treatment groups by computer-generated
numbers: [1] study group will have Foley-catheter intrauterine balloon dilatation therapy 2
weeks and 4 weeks after hysteroscopic myomectomy; [2] the control group will not receiveany
balloon therapy. A second-look hysteroscopy will be carried out around 6 weeks after the
surgery.
Procedure
Surgical procedure
The surgery will be carried out by an experienced hysteroscopic surgeons with the use of a
8.5 mm rigid hysteroscope with under 100-120 mm Hg pressure. The procedure will be performed
under general anesthesia in a day surgery unit under ultrasonographic guidance. Once the
type and number of myomas have been verified, the myoma will be then be bluntly dissected
from the muscular layer with the tip of the resectoscope. After the myomas have been
dissected from the muscular layer, they will be shaved into pieces to reduce the volume and
then be retrieved from the uterine cavity with a myoma grasper.
Postoperative treatments
All patients will be treated with oral antibiotics for 3-5 days in line with local practice.
Second-look hysteroscopy will be carried out 6 weeks after the initial operation. After
assessment of the extent and severity of any newly formed adhesion, hysteroscopic
adhesiolysis, if needed, will be carried out at the time of the second-look procedure.
Immediately prior to second look hysteroscopy, a swab will be taken from the endo-cervical
canal for routine bacteriological study; At the conclusion of the second look hysteroscopy,
an endometrial sample will be obtained for histological study &immune histochemical analysis
including evidence of chronic endometrtitis(CD138 staining). The surgeons who perform the
second-look will be blinded to the randomization.
IUB dilatation therapy
IUB dilatation therapy will be performed according to the methodology published in the
literature. In brief, a Foley catheter (size 12-14fr) 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.
Statistical Analysis
The efficacy of treating the intrauterine adhesions in the two groups will be compared using
the χ2 test. The AFS score in the two groups will be compared using the Mann-Whitney U test.
A p value of < 0.05 will be considered statistically significant. All statistical analysis
will be carried out with the use of SPSS 21.0.
Power calculation
On the basis of the investigators own internal audit and the results of the two published
retrospective cohort studies analysing the prevalence of intrauterine adhesion (IUA)
formation in women undergoing transcervical resection of multiple submucousmyomas (TCRM),the
investigators estimated that the adhesion formation rate in the control group to be 25% and
the treatment group (balloon group) to be 5%; accepting a type 1 error of 0.05, and a type 2
error of 0.10, the number of subjects required in each arm of the randomized controlled
trial would be 51. Assuming that the drop-out rate to be 10%, the total number of subject to
be recruited would be 56 in each arm, that is a total of 112.
Outcome measures
The primary outcome measure will be the amount of intrauterine adhesions as measured
according to the AFS score at follow-up. The secondary outcome measures will include any
complications including any clinical infection and change of menstrual pattern after surgery
and the need for re-operation.
Data processing and analysis
The researchers will ensure the confidentiality of sensitive data by minimizing the number
of personnel who handle subject data. In addition, computer data will be encrypted as
required to maximize security, while paper documents will be locked in filing cabinets, with
only authorized personnel having access to the information.
Ethical considerations
IUB dilatation has been published as a novel technique with no untoward complications
identified to date. The procedure will be performed according to the methodology available
in the literature and the study has gained approval from the local ethical committee
(Approval Notice Number:2016FXHEC—KY005).
Consent
All subjects will be given a detailed explanation of the study and sufficient time to
consider participants. A written consent form will be signed by the patient and retained in
the investigators confidential records.
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