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Hysteroscopic Monopolar and Bipolar Resection

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2006 by Ullevaal University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Ullevaal University Hospital
ClinicalTrials.gov Identifier:
NCT00323999
First received: May 9, 2006
Last updated: NA
Last verified: May 2006
History: No changes posted
  Purpose

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.


Condition Intervention
Menorrhagia
Fibroid
Polyps
Procedure: Hysteroscopic resection of fibroids, polyps and endometrium.

Study Type: Interventional
Official Title: A Randomised Trial to Compare the Differences Between Monopolar Surgery (Loop Resection) With Glycine 1,5% and Bipolar Surgery With Saline (Olympus,Versapoint) on Hysteroscopic Surgery.

Further study details as provided by Ullevaal University Hospital:

Study Start Date: December 2004
Estimated Study Completion Date: December 2007
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00323999

Contacts
Contact: Anette Berg, MD +4795219282 anette.berg@uus.no
Contact: Olav Istre, MD., PhD. +4741302221 oistre@c2i.net

Locations
Norway
Gynaecological department Ullevaal University Hospital Recruiting
Oslo, Norway
Sponsors and Collaborators
Ullevaal University Hospital
Investigators
Principal Investigator: Olav Istre, MD., PhD. Department of Gynaecology, Ullevaal University Hospital, Oslo, Norway
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00323999     History of Changes
Other Study ID Numbers: AB170262
Study First Received: May 9, 2006
Last Updated: May 9, 2006
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Ullevaal University Hospital:
Hysteroscopic resection
Menorrhagia
fibroids
polyps

Additional relevant MeSH terms:
Menorrhagia
Genital Diseases, Female
Menstruation Disturbances
Pathologic Processes
Uterine Diseases
Uterine Hemorrhage

ClinicalTrials.gov processed this record on November 19, 2014