Safety of Leaving Cook Balloon Uterine Stent in Uterus for One Month

The recruitment status of this study is unknown because the information has not been verified recently.

Verified July 2010 by Shin Kong Wu Ho-Su Memorial Hospital.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Shin Kong Wu Ho-Su Memorial Hospital

ClinicalTrials.gov Identifier:

NCT01167296

First received: July 21, 2010

Last updated: NA

Last verified: July 2010

History: No changes posted

Purpose

To use Cook balloon uterine stent to prevent intrauterine adhesion (IUA), and to see if leaving it in the uterus will cause uterine infection.

Condition	Intervention	Phase
Intrauterine Adhesion	Device: Cook balloon uterine stent	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Adhesions

U.S. FDA Resources

Further study details as provided by Shin Kong Wu Ho-Su Memorial Hospital:

Primary Outcome Measures:

intrauterine bacteria count [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

intrauterine adhesion [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	July 2010
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Cook balloon uterine stent Immediately before hysteroscopic surgery, a culture tip is inserted into the uterine cavity and sent for culture. Another culture was done 30 days later, and a second-look hysteroscope is done to evaluate the healing of uterine cavity.removed uterine stent was sent for bacterial culture too.	Device: Cook balloon uterine stent Immediately before hysteroscopic surgery, a culture tip is inserted into the uterine cavity and sent for culture. Another culture was done 30 days later, and a second-look hysteroscope is done to evaluate the healing of uterine cavity.
Experimental: without Cook balloon uterine stent Immediately before hysteroscopic surgery, a culture tip is inserted into the uterine cavity and sent for culture. Another culture was done 30 days later, and a second-look hysteroscope is done to evaluate the healing of uterine cavity.	Device: Cook balloon uterine stent Immediately before hysteroscopic surgery, a culture tip is inserted into the uterine cavity and sent for culture. Another culture was done 30 days later, and a second-look hysteroscope is done to evaluate the healing of uterine cavity.

Detailed Description:

Background：Intrauterine adhesion (IUA) can cause infertility. Hysteroscopic surgery can effectively treat most IUA. In order to prevent adhesion reformation after surgery, most gynecologists will prescribe high-dose estrogen to stimulate endometrial growth, and leave an IUD or a Foley catheter in uterus for 1-3 months. But neither IUD nor Foley catheter conform to the uterine cavity. The Cook balloon uterine stent was designed to fit into the uterine cavity. But it was designed to tamponade the uterus to prevent post-operative uterine bleeding. It's not known if it can be left in the uterus for 30 days.

Study Design：Uterine culture was done before hysteroscopic surgery, and 30 days later. The study group comprise patients with uterine stent; the control group comprise patients who undergo hysteroscopic surgeries but without uterine stent.

Method：Immediately before hysteroscopic surgery, a culture tip is inserted into the uterine cavity and sent for culture. Another culture was done 30 days later, and a second-look hysteroscope is done to evaluate the healing of uterine cavity. The removed uterine stent was sent for bacterial culture too. The same procedures are done for patients with and without uterine stent. The bacterial counts will be compared before and after hysterosocpic surgeries, and between the two groups of patients.

Effect：If leaving the uterine stent in the uterus up to 30 days does not cause bacteria to grow, we can be confident to leave the stent for 30 days.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

intrauterine adhesion women

Exclusion Criteria:

allergic to Cook balloon uterine stent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01167296

Contacts

Contact: Yu-Hung Lin, MD	886-2-28332211 ext 3879	m002179@ms.skh.org.tw
Contact: Heng-Ju Chen, MD	886-2-28332211 ext 3879	m004983@ms.skh.org.tw

Locations

Taiwan
Department of Obstetrics and Gynecology, Shin-Kong Wu-Ho-Su Memerial Hospital	Recruiting
Taipei, Taiwan, 111
Contact: Yu-Hung Lin, MD 886-2-28332211 ext 3879 m002179@ms.skh.org.tw
Contact: Heng-Ju Chen, MD 886-2-28332211 ext 3879 m004983@ms.skh.org.tw
Principal Investigator: Yu-Hung Lin, MD

Sponsors and Collaborators

Shin Kong Wu Ho-Su Memorial Hospital

More Information

No publications provided

Responsible Party:	Yu-Hung Lin, Shin-Kong Wu Ho-Su Memorial Hospital
ClinicalTrials.gov Identifier:	NCT01167296 History of Changes
Other Study ID Numbers:	SKH-8302-99-DR-27
Study First Received:	July 21, 2010
Last Updated:	July 21, 2010
Health Authority:	Taiwan: Institutional Review Board

Keywords provided by Shin Kong Wu Ho-Su Memorial Hospital:

Intrauterine adhesion
Cook balloon uterine stent

Additional relevant MeSH terms:

Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013

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