A Review on the Outcome of Patient Managed in Postmenopausal Bleeding Clinic

• ClinicalTrials.gov Identifier: NCT03382145
• Recruitment Status: Recruiting
• First Posted: December 22, 2017
• Last Update Posted: January 4, 2022
• Sponsor: Chinese University of Hong Kong
• Information provided by (Responsible Party): CHEUNG CHUN WAI, Chinese University of Hong Kong

Study Description

Brief Summary:

Postmenopausal bleeding (PMB) is a common gynaecological complaint, accounting for up to 5 to 10 % of postmenopausal women being referred to gynaecological outpatient clinic. It also comprised of up to 10% of our outpatient gynaecological referral. In general, 60 % of women with postmenopausal bleeding have no organic causes identified, whilst benign causes of PMB includes atrophic vaginitis, endometrial polyp, submucosal fibroid and functional endometrium. However, between 5.7 to 11.5% of women with postmenopausal bleeding have endometrial carcinoma, which is the fourth most common cancer among women, therefore, it is important to investigate carefully to exclude genital tract cancer.

A One-stop postmenopausal bleeding clinic has been established since February, 2002 by the Department of Obstetrics and Gynaecology, New Territories East cluster (NTEC) aiming at providing immediate assessment of women with postmenopausal bleeding in one single outpatient clinic assessment. During the visit, a detailed history was taken in regarding the PMB and usage of hormonal replacement therapy or herbal medicine. A physical examination was performed and a cervical smear was taken if not been taken within a year. Transvaginal ultrasound (TVS) was then performed to measure the endometrial thickness (ET), examining ovaries then followed by an endometrial sampling. An outpatient hysteroscopy was performed only if TVS showed an ET >= 5mm, or an abnormal endometrial appearance or unsatisfactory ET. Benign looking endometrial polyp would be removed during the outpatient hysteroscopy if possible.

At the moment, there was very limited local data and lack of the long term result. Investigators aim to retrospectively evaluate the clinical outcome of postmenopausal bleeding patients who has attended One Stop Postmenopausal Clinic in order to formulate better care and counseling in future.

Objectives:

1. To analyze histopathology in relative to history and ultrasound findings in PMB women presented to One Stop Postmenopausal Bleeding Clinic at NTEC
2. To correlate the clinical findings of transvaginal ultrasonography (TVS) with outpatient hysteroscopy and endometrial assessment in The One Stop Postmenopausal Bleeding Clinic
3. To identify predictive and prognostic factors in women with PMB for possible use in triaging high risk patients

Condition or disease	Intervention/treatment
Postmenopausal Bleeding	Other: No intervention

Detailed Description:

Postmenopausal bleeding (PMB) is a common gynaecological complaint, accounting for up to 5 to 10 % of postmenopausal women being referred to gynaecological outpatient clinic. It also comprised of up to 10% of our outpatient gynaecological referral. In general, 60 % of women with postmenopausal bleeding have no organic causes identified, whilst benign causes of PMB includes atrophic vaginitis, endometrial polyp, submucosal fibroid and functional endometrium. However, between 5.7 to 11.5% of women with postmenopausal bleeding have endometrial carcinoma, which is the fourth most common cancer among women, therefore, it is important to investigate carefully to exclude genital tract cancer.

In the past, often women with PMB require multiple clinic visits in order to reach a final diagnosis. This not only increase the medical cost as a whole, but also imposes an enormous stress and burden on patients, concerning about delayed or overlooked diagnosis of genital tract cancer.

A One-stop postmenopausal bleeding clinic has been established since February, 2002 by the Department of Obstetrics and Gynaecology, New Territories East cluster (NTEC) aiming at providing immediate assessment of women with postmenopausal bleeding in one single outpatient clinic assessment.

During the visit, a detailed history was taken in regarding the PMB and usage of hormonal replacement therapy or herbal medicine. A physical examination was performed and a cervical smear was taken if not been taken within a year. Transvaginal ultrasound (TVS) was then performed to measure the endometrial thickness (ET), examining ovaries then followed by an endometrial sampling. An outpatient hysteroscopy was performed only if TVS showed an ET >= 5mm, or an abnormal endometrial appearance or unsatisfactory ET. Benign looking endometrial polyp would be removed during the outpatient hysteroscopy if possible.

At the moment, there was very limited local data and lack of the long term result. Investigators aim to retrospectively evaluate the clinical outcome of postmenopausal bleeding patients who has attended One Stop Postmenopausal Clinic in order to formulate better care and counseling in future.

Objectives:

1. To analyze histopathology in relative to history and ultrasound findings in PMB women presented to One Stop Postmenopausal Bleeding Clinic at NTEC
2. To correlate the clinical findings of transvaginal ultrasonography ( TVS) with outpatient hysteroscopy and endometrial assessment in The One Stop Postmenopausal Bleeding Clinic
3. To identify predictive and prognostic factors in women with PMB for possible use in triaging high risk patients

Methodology A. Subjects Postmenopausal women who attended the One Stop Postmenopausal Bleeding Clinic since year 2002 B. Methods All women with postmenopausal bleeding presented to One-Stop PMB clinic were enrolled for analysis. Menopause was defined as the cessation of menses for more than 1 year. These patients had a thorough history taken. A physical examination was performed. A vaginal ultrasound was performed to determine uterine dimension, the endometrial thickness (ET) and exclude other adnexal pathology. An Endometrial sampling was taken afterward. An outpatient hysteroscopy , a 2.7mm or 2mm 30 degree rigid hysteroscope was then inserted into the uterine cavity using either CO2 or normal saline as distending medium to identify uterine pathology if TVS showed an ET >= 5mm, or an abnormal endometrial appearance, or unsatisfactory ET. Benign looking endometrial polyps were removed during the outpatient hysteroscopy if possible. The management was determined by the finding on transvaginal ultrasonography and hysteroscopy. If surgery was indicated, appropriate surgery would be booked in the clinic. Patient was discharged from the clinic if the findings were normal. A call-back system was established to recall patients with abnormal pathology. A follow up appointment would be given in case of suspicious pathology or incomplete examination.

The data was transferred into a computer database which will be analyzed. Medical records of all patients who presented to our One- Stop clinic at New Territories East Cluster will be reviewed. Patient's demographic data, presenting symptoms, clinical assessments, investigations and treatments will be collected. If they had operations performed, surgical pathology, if any, will also be reviewed. The outcomes in terms of death or still being alive are also ascertained from the Computerized Medical System.

Data and Analysis Data will be analysed using SPSS 22.0 (SPSS Inc., Chicago, IL, USA) program. For comparison of frequencies, chi-square test or or a two-sided Fishers' exact test will be used where appropriate. The Mann- Whitney U Test will be used to compare nonparametric data and the Kolmogorov-Smirnov test for correlation analysis with P<0.05 as indication of significance.

Implication of Data Postmenopausal bleeding (PMB) is a worrisome symptom that requires urgent investigation because of its association with genital tract malignancy. One-stop postmenopausal bleeding clinic is becoming a trend, which has been effective in reducing the number of hospital visits per patient as well as decreasing patient anxiety (9). The review of the results of our One Stop Clinic which allows us to have better understanding of our patient's characteristics, risk factors and underlying pathologies in causing PMB. These could provide a better local evidence for future clinical use and patient care. The data helps to provide the basis for further improvement and streamlining the service as well as finding new approaches in the organization of the service.

Study Design

• Study Type: Observational
• Estimated Enrollment: 15500 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: A Review on the Outcome of Patient Managed in One Stop Postmenopausal Bleeding Clinic in New Territories East Cluster, NTEC
• Actual Study Start Date: February 1, 2018
• Estimated Primary Completion Date: December 31, 2023
• Estimated Study Completion Date: December 31, 2023

Groups and Cohorts

Group/Cohort	Intervention/treatment
postmenopausal bleeding women; Retrospective review on outcome of One stop Postmenopausal bleeding clinic in New Territorial Eastern Cluster, Hong Kong. Single group study, no intervention.	Other: No intervention; No intervention

Outcome Measures

Primary Outcome Measures :

1. To assess any correlation between histolopathology and transvaginal ultrasonography in postmenopausal women at Tertiary centre [ Time Frame: Baseline ]
   To review all Medical records of all patients who presented to our One- Stop clinic at New Territories East Cluster will be reviewed. Patient's demographic data, presenting symptoms, clinical assessments, investigations and treatments will be collected. If they had operations performed, surgical pathology, if any, will also be reviewed.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

All women with postmenopausal bleeding presented to One-Stop PMB clinic were enrolled for analysis. Menopause was defined as the cessation of menses for more than 1 year.

Criteria

Inclusion Criteria:

• Menopausal
• postmenopausal bleeding

Exclusion Criteria:

• had less than one year of amenorrhoea
• amenorrhoea due to medication

Contacts and Locations

Contacts

Contact: Chun Wai Cheung; 852-35052813; evacwcheung@cuhk.edu.hk

Locations

Hong Kong

The Chinese University of Hong Kong; Recruiting

Hong Kong, Hong Kong

Contact: Chun Wai Cheung 852-35052813 evacwcheung@cuhk.edu.hk

Sponsors and Collaborators

Chinese University of Hong Kong

Investigators

• Principal Investigator: Chun Wai Cheung; Chinese University of Hong Kong

  Study Documents (Full-Text)

Documents provided by CHEUNG CHUN WAI, Chinese University of Hong Kong:

Study Protocol  [PDF] October 20, 2017

More Information

• Responsible Party: CHEUNG CHUN WAI, clinical Honorary Associate Professor, Chinese University of Hong Kong
• ClinicalTrials.gov Identifier: NCT03382145
• Other Study ID Numbers: CRE 2017.475
• First Posted: December 22, 2017
• Last Update Posted: January 4, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Uterine Diseases