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
Recruitment status was Recruiting
Sponsor:
Ullevaal University Hospital
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
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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 |
- 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.
-
Contacts and Locations
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:
|
Leiomyoma Myofibroma Menorrhagia Polyps Neoplasms, Muscle Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms |
Neoplasms, Connective Tissue Connective Tissue Diseases Uterine Hemorrhage Uterine Diseases Genital Diseases, Female Menstruation Disturbances Pathologic Processes Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on May 16, 2013