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

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Intrauterine Adhesion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Cook balloon uterine stent

Intervention Type DEVICE

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.

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.

Group Type EXPERIMENTAL

Cook balloon uterine stent

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE