Intrauterine Balloon and Postoperative Estrogen Therapy in the Prevention of Adhesion Reformation After Hysteroscopic Adhesiolysis

NCT ID: NCT02617108

Last Updated: 2019-10-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 310 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-31
• Study Completion Date: 2021-11-30

Brief Summary

Patients who want to go TCRS will randomly divided 3 groups. In Group 1(100 patients), women received postoperative estrogen therapy. In Group 2 (100 patients), a Foley catheter with the balloon inflated with 4 ml of normal saline solution will be placed into the uterine cavity at the end of the operation for five days. In Group 3 (110 patients), women will not receive any of the treatment (comparison group). All subjects underwent two further hysteroscopy, one and three months after the initial surgery. At the second or third look hysteroscopy, the incidence of intra-uterine adhesion will be analyzed.

Detailed Description

The uterine septum (US) is the most common congenital uterine malformation, accounting for about 75% of Mullerian anomalies. Transcervical resection of septum (TCRS) has been shown in several cohort studies to improve outcome, although evidence from prospectively conducted randomized trial is lacking. TCRS is generally considered to be safe but there is a concern that it may be complicated by post-operative formation of intrauterine adhesions. Some investigators therefore recommend the use of postoperative adjuvant therapies with a view to preventing adhesion formation, as in the case of hysteroscopic surgery for Asherman syndrome. The adjuvant measures proposed include postoperative estrogen therapy, the placement of an intrauterine device (IUD) or Foley catheter in the uterine cavity. Unlike the case of Asherman syndrome in which these various adjuvant therapies are often used and appear to be of benefit, it is uncertain if any of these adjuvant measures are of benefit or necessary in the case TCRS. In this study, the investigators will compare the postoperative adhesion formation rates who will receive Foley catheter therapies 、postoperative estrogen therapy and those who will not receive any therapies to determine the usefulness of Foley catheter therapies in reducing postoperative adhesion formation.

Conditions

Uterine Septum

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Foley balloon

Foley balloon following TCRS: a Foley balloon with 4 ml of normal saline solution will be placed into the uterine cavity at the end of the operation for five days.

Group Type: EXPERIMENTAL

Foley balloon

Intervention Type: DEVICE

a Foley balloon with 4 ml of normal saline solution will be placed into the uterine cavity at the end of the operation for five days.

control groups

control groups: women will not receive any therapy of the treatment (comparison group).

Group Type: NO_INTERVENTION

No interventions assigned to this group

postoperative estrogen therapy groups

Subjects received postoperative hormone therapy as per the protocol in use in our center for Asherman Syndrome. Immediately after the operation, the subjects were started on a 3- month course of cyclical hormonal therapy, consisting of orally administrated oestradiol valerate 2-4mg/day for 21 days, orally administrated medroxyprogesterone acetate 8mg /day from day 12 to 21 of the oestradiol valerate therapy. The second treatment cycle started one week after the completion of the first cycle, and the third treatment cycle started one week after the second cycle.

Group Type: EXPERIMENTAL

Foley balloon

Intervention Type: DEVICE

a Foley balloon with 4 ml of normal saline solution will be placed into the uterine cavity at the end of the operation for five days.

Interventions

Foley balloon

a Foley balloon with 4 ml of normal saline solution will be placed into the uterine cavity at the end of the operation for five days.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients who will go hysteroscopic transection of uterine septum between 2016 to 2017 at the Hysteroscopy Center, Fuxing Hospital;
• Patients willing to undergo followed hysteroscopy about 4 and 12 weeks after the surgery to assess the reformation of intrauterine adhesions;
• Written informed consent obtained.

Exclusion Criteria

• ongoing pregnancy;
• Peroperative fever or infections;
• Malignancy;
• Precious pelvic inflammatory disease;
• Uterine fibroid (>3cm size);
• endometriosis;
• Contraindications for anesthesia;
• Not able to read and/or understand informed consent.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fu Xing Hospital, Capital Medical University

OTHER

Sponsor Role: lead

Responsible Party

Xiao Yu

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tinchiu Li, Ph.D.

Role: STUDY_DIRECTOR

Chinese University of Hong Kong

Central Contacts

Yu Xiao, Ph.D.

Role: CONTACT

729995176@qq.com

+86-18601262217

References

Hassan MA, Lavery SA, Trew GH. Congenital uterine anomalies and their impact on fertility. Womens Health (Lond). 2010 May;6(3):443-61. doi: 10.2217/whe.10.19.

Reference Type: BACKGROUND

PMID: 20426609 (View on PubMed)

Brucker SY, Rall K, Campo R, Oppelt P, Isaacson K. Treatment of congenital malformations. Semin Reprod Med. 2011 Mar;29(2):101-12. doi: 10.1055/s-0031-1272472. Epub 2011 Mar 24.

Reference Type: BACKGROUND

PMID: 21437824 (View on PubMed)

Lin X, Wei M, Li TC, Huang Q, Huang D, Zhou F, Zhang S. A comparison of intrauterine balloon, intrauterine contraceptive device and hyaluronic acid gel in the prevention of adhesion reformation following hysteroscopic surgery for Asherman syndrome: a cohort study. Eur J Obstet Gynecol Reprod Biol. 2013 Oct;170(2):512-6. doi: 10.1016/j.ejogrb.2013.07.018. Epub 2013 Aug 7.

Reference Type: BACKGROUND

PMID: 23932377 (View on PubMed)

Conforti A, Alviggi C, Mollo A, De Placido G, Magos A. The management of Asherman syndrome: a review of literature. Reprod Biol Endocrinol. 2013 Dec 27;11:118. doi: 10.1186/1477-7827-11-118.

Reference Type: BACKGROUND

PMID: 24373209 (View on PubMed)

Other Identifiers

FuXingH2

Identifier Type: -

Identifier Source: org_study_id