Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00322

2 Trial Registration Date

2012-07-03

i Registration Status

Prospective

3 Secondary IDs

Nil

4 Source(s) of Funding

Department of Obstetrics and Gynaecology, The Chinese University of Hong Kong

5 Primary Sponsor

Nil

6 Secondary Sponsor

Nil

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Carol Chan

ii Address

1/F, Block F, Department of Obstetrics &Gynaecology, Prince of Wales Hospital

iii Phone

26321764

iv Email

carolchan@cuhk.edu.hk

v Affiliation

Nil

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Dr. Mei Ling Cheung

ii Address

1/F, Block F, Department of Obstetrics &Gynaecology, Prince of Wales Hospital

iii Phone

26323190

iv Email

irenecheung@cuhk.edu.hk

v Affiliation

Nil

vi Country

9 Official Scientific Title of the Study

Impact of Electrocoagulation versus a gelantine-thrombin matrix sealant (FloSeal©) on ovarian reserve after laparoscopic stripping of ovarian endometriomas

10 Public Title

Impact of Electrocoagulation versus a gelantine-thrombin matrix sealant (FloSeal©) on ovarian reserve after laparoscopic stripping of ovarian endometriomas

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Nil

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2011-09-06

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

All patients with clinical and ultrasound diagnosis of unilateral ovarian endometriomas will be recruited

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

Application of gelantine-thrombin matrix sealant (FloSeal) for haemostasis after the stripping of endometriomas

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

After removal of the cyst wall, FloSeal is applied directly inside the ovary wound. It is biocompati

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Bipolar electrocoagulation

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Patient with clinical and ultrasound diagnosis of unilateral ovarian endometriomas. Aged between 18 and 40 years with regular menstrual cycles (21-35 days) at the time of operation.

ii Exclusion Criteria

Patient with polycystic ovarian syndrome according to the Rotterdam criteria 20, pregnancy, active pelvic inflammatory disease, genital or extragenital malignancy, intraoperative diagnosis of another cyst type, conversion to laparotomy, use of GnRH or COC therapy in the follow–up period, and irregular attendance of follow-up examinations. Refuse or incompetence for informed consent.

iii Age Minimum

18

iv Age Maximum

40

v Gender

Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Active

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2012-07-06

21 Target Sample Size

94

22 Recruitment Status

Recruiting

23 Primary Outcome

Evaluation of ovarian reserve by
1) Pre- and postoperative hormonal profiles including, AMH, FSH, LH, testosterone and estradiol.
2) Ultrasound findings such as antral follicle count, ovarian stromal blood flow, ovarian volume

24 Secondary Outcome

1) The operative finding - the estimated blood loss and operative duration are recorded.
2) Assessment of patient satisfaction - Patient attitude towards the treatment will be assessed by an 8-item client satisfaction questionnaire (CSQ-8).
3) Experience of any complications.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2021-07-22

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-12002358

28 Date of Registration in Primary Registry

2012-07-22

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

Nil

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Trial History Detail on 2012-12-11