Hysteroscopic Monopolar and Bipolar Resection

May 9, 2006 updated by: Ullevaal University Hospital

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Olav Istre, MD., PhD.
  • Phone Number: +4741302221
  • Email: oistre@c2i.net

Study Locations

  • Norway
      • Oslo, Norway
        • Recruiting
        • Gynaecological department Ullevaal University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ullevaal University Hospital

Investigators

  • Principal Investigator: Olav Istre, MD., PhD., Department of Gynaecology, Ullevaal University Hospital, Oslo, Norway

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Study Completion

December 1, 2007

Study Registration Dates

First Submitted

May 9, 2006

First Submitted That Met QC Criteria

May 9, 2006

First Posted (Estimate)

May 10, 2006

Study Record Updates

Last Update Posted (Estimate)

May 10, 2006

Last Update Submitted That Met QC Criteria

May 9, 2006

Last Verified

May 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AB170262

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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