Immediate and Delayed Intrauterine Balloon in the Prevention of Adhesion Reformation After Hysteroscopic Adhesiolysis
NCT ID: NCT03171454
Last Updated: 2017-06-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
180 participants
INTERVENTIONAL
2017-05-30
2018-12-31
Brief Summary
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Detailed Description
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To compare the efficacy of placing an Intrauterine Balloon immediately after surgery and delayed Intrauterine Balloon Dilatation Therapy after surgery in the prevention of adhesion reformation after hysteroscopic adhesiolysis.
Patients
The patients will be recruited from two centers, namely, the HysterscopyCenter of the Fuxing Hospital and TianTan Hospital, Capital Medical University, Beijing, China.Before the surgery all patients with suspected Asherman syndrome will undergo preoperative evaluations, including a detailed history of the menstrual pattern, any previous intrauterine surgery, and reproductive history, as well as trans-vaginal ultrasonography.The severity and extent of intrauterine adhesions will be scored according to a classification system recommended by the American Fertility Society (AFS) (1988 version). The inclusion criteria include \[1\] women aged 18-40 years; \[2\] moderate to severe intrauterine adhesion (AFS score≥5); \[3\] first episode of hysteroscopic adhesiolysis in the investigators hospital; \[4\] written consent obtained; and \[5\] agreement to have second-look hysteroscopy. The exclusion criteria include \[1\] minimal adhesion (AFS score \<5) and \[2\] previous hysteroscopic adhesiolysis in the investigators hospital.
Study Design
At the conclusion of hysteroscopic adhesiolysis, recruited patients will be randomized to one of the two treatment groups by computer-generated numbers: \[1\] Immediate Intrauterine Balloon therapy (I-IUB) group: Immediately place a Foley-catheter intrauterine balloon which will be removed after 7 days after surgery; \[2\] Delayed Intrauterine Balloon therapy (D-IUB) group： insertion of a Foley-catheter to distend the uterine cavity 2 weeks and 4 weeks after hysteroscopic adhesiolysis; A second-look hysteroscopy will be carried out in the early proliferative phase 6 weeks after the surgery.
Power Calculation
On the basis of the results of the two published retrospective cohort studies comparing the balloon and hormone therapy group (control group) in the prevention of adhesion reformation, the investigators estimate that the adhesion reformation rate in the immediate balloon group to be 30% and in the delayed balloon group to be 10%. Accepting a type 1 error of 0.05, and a type 2 error of 0.10, the number of subjects in each arm of the randomized, controlled trial would be 79. Assuming that the dropout rate to be 20%, the total number of subject to be recruited would be 90 in each arm.
Procedure
Surgical procedure
The surgery will be carried out by one of three experienced hysteroscopic surgeons with the use of a 8.5-mm rigid hysteroscope (Olympus) with 0.9% normal saline infusion under 100-120 mmHg pressure. The procedure will be performed under general anesthesia in a day surgery unit. Ultrasonographic guidance will be routinely used. Once the extent and severity of uterine adhesion has been assessed, the adhesions will be divided with the use of bipolar instrument until normal uterine anatomy is achieved.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. 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 3-5ml) 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.
Postoperative treatments
All subjects will be treated with oral antibiotics for 5 days. In all cases hormone therapy will also begin from the day of operation, consisting of estradiol at a dose of 2 mg, bid for 21- 28 days, with the addition of dydrogesterone at a dose of 10 mg, bid for the last 10 days of the estrogen therapy. After the withdrawal bleed, the hormone therapy will be repeated for another cycle. Second-look hysteroscopy will be carried out in the early proliferative phase, 6 weeks after the initial operation. After assessment of the extent and severity of any reformed adhesion, hysteroscopic adhesiolysis will also be carried out at the time of the second-look procedure, if adhesion has recurred. The surgeon who performs the second-look hysteroscopy will be blinded to the randomization.
IUB dilatation
D-IUB dilatation therapy group will be performed using a 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.
Statistical Analysis
The rate of the recurrence of adhesion in the two groups will be compared using the χ2 test. The reduction of 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.
Outcome measures
The primary outcome measure will include the degree of intrauterine adhesions and AFS score at follow-up. The secondary outcome measures will include the change of menstrual pattern after surgery and the need for re-operation.The third outcome measures will include any complications including any clinicalinfection.
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.
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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* moderate to severe intrauterine adhesion (AFS score≥5);
* first episode of hysteroscopicadhesiolysis in our hospital;
* written consent obtained;
* agreement to have second-look hysteroscopy.
Exclusion Criteria
* previous hysteroscopic adhesiolysis in our hospital.
18 Years
40 Years
FEMALE
No
Sponsors
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Beijing Tiantan Hospital
OTHER
Fu Xing Hospital, Capital Medical University
OTHER
Responsible Party
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Xiaoyu Shi
Principal Investigator
Principal Investigators
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Tinchiu Li
Role: STUDY_CHAIR
Fu Xing Hospital, Capital Medical University
Locations
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Fu Xing Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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March CM. Intrauterine adhesions. Obstet Gynecol Clin North Am. 1995 Sep;22(3):491-505.
Saravelos SH, Li TC. Ultrasound-guided treatment of intrauterine adhesions in the outpatient setting. Ultrasound Obstet Gynecol. 2017 Aug;50(2):278-280. doi: 10.1002/uog.16218. No abstract available.
Saravelos SH and Li TC. Intrauterine balloon therapy: a novel ultrasound guided treatment for intrauterine adhesions. Gynecological Surgery [Epub ahead of print]
Saravelos SH, Jayaprakasan K, Ojha K, Li TC. Assessment of the uterus with three-dimensional ultrasound in women undergoing ART. Hum Reprod Update. 2017 Mar 1;23(2):188-210. doi: 10.1093/humupd/dmw040.
Orhue AA, Aziken ME, Igbefoh JO. A comparison of two adjunctive treatments for intrauterine adhesions following lysis. Int J Gynaecol Obstet. 2003 Jul;82(1):49-56. doi: 10.1016/s0020-7292(03)00030-4.
Taskin O, Sadik S, Onoglu A, Gokdeniz R, Erturan E, Burak F, Wheeler JM. Role of endometrial suppression on the frequency of intrauterine adhesions after resectoscopic surgery. J Am Assoc Gynecol Laparosc. 2000 Aug;7(3):351-4. doi: 10.1016/s1074-3804(05)60478-1.
Healy MW, Schexnayder B, Connell MT, Terry N, DeCherney AH, Csokmay JM, Yauger BJ, Hill MJ. Intrauterine adhesion prevention after hysteroscopy: a systematic review and meta-analysis. Am J Obstet Gynecol. 2016 Sep;215(3):267-275.e7. doi: 10.1016/j.ajog.2016.05.001. Epub 2016 May 10.
Guida M, Acunzo G, Di Spiezio Sardo A, Bifulco G, Piccoli R, Pellicano M, Cerrota G, Cirillo D, Nappi C. Effectiveness of auto-crosslinked hyaluronic acid gel in the prevention of intrauterine adhesions after hysteroscopic surgery: a prospective, randomized, controlled study. Hum Reprod. 2004 Jun;19(6):1461-4. doi: 10.1093/humrep/deh238. Epub 2004 Apr 22.
Roge P, D'Ercole C, Cravello L, Boubli L, Blanc B. Hysteroscopic management of uterine synechiae: a series of 102 observations. Eur J Obstet Gynecol Reprod Biol. 1996 Apr;65(2):189-93. doi: 10.1016/0301-2115(95)02342-9.
Schenker JG. Etiology of and therapeutic approach to synechia uteri. Eur J Obstet Gynecol Reprod Biol. 1996 Mar;65(1):109-13. doi: 10.1016/0028-2243(95)02315-j.
Pabuccu R, Atay V, Orhon E, Urman B, Ergun A. Hysteroscopic treatment of intrauterine adhesions is safe and effective in the restoration of normal menstruation and fertility. Fertil Steril. 1997 Dec;68(6):1141-3. doi: 10.1016/s0015-0282(97)00375-0.
Other Identifiers
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2017FXHEC-KY006
Identifier Type: -
Identifier Source: org_study_id
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