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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00323999
Other study ID # AB170262
Secondary ID
Status Recruiting
Phase N/A
First received May 9, 2006
Last updated May 9, 2006
Start date December 2004
Est. completion date December 2007

Study information

Verified date May 2006
Source Ullevaal University Hospital
Contact Anette Berg, MD
Phone +4795219282
Email anette.berg@uus.no
Is FDA regulated No
Health authority Norway:National Committee for Medical and Health Research Ethics
Study type Interventional

Clinical Trial Summary

The aim of the study is to evaluate bipolar equipment versus monopolar, and to see if there is any differences between the two types of bipolar equipment espescially regading both safety and effect.


Description:

- Trial design: A prospective randomised study with three arms, one arm with monopolar surgery and two different arms with bipolar surgery. Its a one center study.

- Trial population: Pre-or perimenopausal women reffered to our clinic with bleeding disorders and were we plan to do endometrial resection. Patients with a bleeding disorder due to fibroids type 0 and 1 will be included and patients with polyps were endometrial resection is planned at the same time will also be included.

- Preoperative selection: The fibroids will be mapped using transvaginal ultrasound according to the classification ESGE. Type 0 and 1 fibroids will be included. Diameter of the fibroid must not extend 4cm. The endometrium size double layer will be recorded. Uterine size anetrior /posterior diameter, longitudinal diameter (cavity; top fundal to isthmus) will be measured. Were polyps are included these will be measured; length and width. Higham score (PBAC), Se-hgb, Ferritin, FSH and Oestradiol will be documented at all visits. Menstrual pain will be documented due to a VAS-scale.

- Treatment regimen:Randomisation in blocs of 20 between monopolar and two types of bipolar surgery.

- Surgical Technique: The cervical canal will be dilated to Hegar 10 or 11 and a rigid resectoscope Ch. 26 is passed to the uterine cavity. Glycine 1,5% or Saline (Baxter) is infused to irrigate the uterine cavity (Iglesias technique) Automatic pressure cuff maintains an infusion pressure of 100mm Hg and suction 10-15mmHg is applied to the outflow tube in order to achieve a sufficient flow.Fibroids type 0 and 1 are resected in total if possible or flush to the plane of the uterine wall. The tissue chips are removed at intervals by currette and forceps. The operation will be performed by experienced surgeons.

- Primary response variables: Safety is our primary response variable. Fluid absorption and lowering of Se-Sodium will be analysed. These parameters are the only objective parameters which can tell us about safety. Nausea will be reorded on a VAS-scale.

- Secondary resonse variables: Operating time, tissue removed, easisness of operation, levels of vaginal bleeding measured by the methosd of Hgham(PBAC)before and at follow up.

After 6 month and one year we will look at secondary intervention like repeated resection or hysterectomy.


Recruitment information / eligibility

Status Recruiting
Enrollment 0
Est. completion date December 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:-Pre-or perimenopausal women with a bleeding disorder with or without fibroids or polyps -

Exclusion Criteria:-Postmenopausal patient. Infertility. Additional condition requiring treatment detected during examination. Malignancy or atypical hyperplasia detected by histological examination.

Study Design

N/A


Related Conditions & MeSH terms


Intervention

Procedure:
Hysteroscopic resection of fibroids, polyps and endometrium.


Locations

Country Name City State
Norway Gynaecological department Ullevaal University Hospital Oslo

Sponsors (1)

Lead Sponsor Collaborator
Ullevaal University Hospital

Country where clinical trial is conducted

Norway, 

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