NCT03169478

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 30, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

May 30, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

June 7, 2017

Status Verified

June 1, 2017

Enrollment Period

2 years

First QC Date

May 25, 2017

Last Update Submit

June 6, 2017

Conditions

Intrauterine Adhesion

Keywords

hysteroscopic myomectomyballoon dilatationadhesions

Outcome Measures

Primary Outcomes (1)

  • The amount of intrauterine adhesions at second look hysteroscopy

    The amount of intrauterine adhesions according to AFS score at second look hysteroscopy

    at 6 weeks post-op

Secondary Outcomes (2)

  • complications of hysteroscopic myomectomy

    at 6 weeks post-op

  • menstrual pattern

    at 3 months post-op

Study Arms (2)

multiple myoma control group

NO INTERVENTION

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

EXPERIMENTAL

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

Interventions

multiple myoma IUB dilatation groupPROCEDURE

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.

multiple myoma IUB dilatation group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe study focus on intrauterine adhesion only in female patients.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \[1\] 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

You may not qualify if:

  • \[1\] women who are already postmenopausal
  • \[2\] women who have evidence of intrauterine adhesions at the time of surgeryare

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fu Xing Hospital

Beijing, Beijing Municipality, 100038, China

RECRUITING

Related Publications (14)

  • 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.

    PMID: 27420903RESULT

  • Saravelos SH and Li TC. Intrauterine balloon therapy: a novel ultrasound guided treatment for intrauterine adhesions. Gynecological Surgery [Epub ahead of print]

    RESULT

  • 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.

    PMID: 28007752RESULT

  • March CM. Intrauterine adhesions. Obstet Gynecol Clin North Am. 1995 Sep;22(3):491-505.

    PMID: 8524533RESULT

  • 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.

    PMID: 12834941RESULT

  • Varasteh NN, Neuwirth RS, Levin B, Keltz MD. Pregnancy rates after hysteroscopic polypectomy and myomectomy in infertile women. Obstet Gynecol. 1999 Aug;94(2):168-71. doi: 10.1016/s0029-7844(99)00278-1.

    PMID: 10432121RESULT

  • 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.

    PMID: 10924629RESULT

  • Yang JH, Chen MJ, Wu MY, Chao KH, Ho HN, Yang YS. Office hysteroscopic early lysis of intrauterine adhesion after transcervical resection of multiple apposing submucous myomas. Fertil Steril. 2008 May;89(5):1254-1259. doi: 10.1016/j.fertnstert.2007.05.027. Epub 2007 Aug 8.

    PMID: 17686478RESULT

  • Touboul C, Fernandez H, Deffieux X, Berry R, Frydman R, Gervaise A. Uterine synechiae after bipolar hysteroscopic resection of submucosal myomas in patients with infertility. Fertil Steril. 2009 Nov;92(5):1690-3. doi: 10.1016/j.fertnstert.2008.08.108. Epub 2008 Oct 19.

    PMID: 18937941RESULT

  • 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.

    PMID: 27173082RESULT

  • 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.

    PMID: 15105384RESULT

  • 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.

    PMID: 8730623RESULT

  • 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.

    PMID: 8706941RESULT

  • 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.

    PMID: 9418714RESULT

MeSH Terms

Conditions

GynatresiaTissue Adhesions

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesCicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Tinchiu Li

    Fu Xing Hospital, Capital Medical University

    STUDY CHAIR

Central Study Contacts

Lei Guo

CONTACT

+86 15810635320guolei.yale@163.com

Tinchiu Li

CONTACT

+86 010 88062944tinchiu.li@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 25, 2017

First Posted

May 30, 2017

Study Start

May 30, 2017

Primary Completion

May 30, 2019

Study Completion

July 31, 2019

Last Updated

June 7, 2017

Record last verified: 2017-06

Locations

CN(1)