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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01289314
Other study ID # LAP-HYST-TRIAL
Secondary ID
Status Recruiting
Phase N/A
First received February 2, 2011
Last updated February 9, 2011
Start date February 2011
Est. completion date December 2012

Study information

Verified date February 2011
Source Oslo University Hospital
Contact Espen Berner, MD
Phone 0047 22119800
Email espen.berner@uus.no
Is FDA regulated No
Health authority Norway: Data Protection AuthorityNorway: Regional Ethics Commitee
Study type Interventional

Clinical Trial Summary

Objective: To compare the occurrence and intensity of pelvic pain as well as patient satisfaction and quality of life after total laparoscopic and laparoscopic supracervical hysterectomy.

Design: Prospective randomised trial.

Null hypothesis 1: There is no significant difference in occurrence and intensity of pelvic pain following TLH compared with following LSH.

Null hypothesis 2: There is no significant difference in patient satisfaction and quality of life following TLH compared with following LSH.


Description:

Sample: 62 consecutive premenopausal women referred to the department for hysterectomy on the basis of a benign condition. The expected mean pain reduction (m) in the LSH group: 3.32, sd (s): 2.71.24 A difference in mean pain reduction (d) equal to 1 sd is considered a clinically important improvement (standardised difference d/s=1). Number of women required (power 90 % and a level of significance 0.05): 62 patients.

Methods: The study participants are randomised to total laparoscopic hysterectomy (n = 31), or laparoscopic supracervical hysterectomy (n = 31).


Recruitment information / eligibility

Status Recruiting
Enrollment 62
Est. completion date December 2012
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- Premenopausal women who are referred to the department

- benign condition requiring hysterectomy

- Dysmenorrohea/cyclic pelvic pain

- Informed consent

Exclusion Criteria:

- Women who are unable to communicate in Norwegian language.

- Women with a previous history of cervical dysplasia, with cellular changes suggestive of dysplasia in preoperative cervical smear.

- Women with atypical hyperplasia or malignancy in preoperative endometrial biopsy.

- Women with a substantially enlarged uterus requiring abdominal hysterectomy or not suitable for TLH (> 12 week amenorrhea).

- Women with a concomitant condition requiring uni- or bilateral oophorectomy.

- Postmenopausal women.

- Women with no dysmenorrohea/cyclic pelvic pain (<1 on a 10-point visual analogue scale).

- Women with deep infiltrating endometriosis.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
TLH
Total laparoscopic hysterectomy (TLH)
Laparoscopic supracervical hysterectomy
Laparoscopic supracervical hysterectomy (LSH)

Locations

Country Name City State
Norway Dept. of Gynecology, Oslo University Hospital Oslo

Sponsors (1)

Lead Sponsor Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pelvic pain reduction after the procedure. Occurrence and intensity of pelvic pain after the procedure. 10-point visual analogue scale. Values are given as median (range), mean (sd) or n (%). 12 months after the procedure No
Secondary Patient satisfaction after the procedure 10-point visual analogue scale. Values are given as median (range) or mean (sd). 12 months after the procedure No
Secondary Occurrence of vaginal bleeding after the procedure Values are given as no bleeding, n (%); cyclical bleeding, n (%); irregular bleeding, n (%); bleeding related to sexual activity, n (%). 12 months after the procedure No
Secondary Improvement in patient Quality of Life after the procedure SF 36, Values are given as median (range) or mean (sd). 12 months after the procedure No
Secondary Frequency of perioperative and postoperative complications. Values are given as n (%) and eventual complications are specified. Major complications: Major haemorrhage (requiring transfusion), Haematoma requiring transfusion or surgical drainage, Bowel injury, Ureteric injury, Bladder injury, Pulmonary embolus, Major anaesthesia problems, Unintended laparotomy, Wound dehiscence Minor complications: Hemorrhage not requiring transfusion, Infection (chest, wound, pelvic, other; or fever >= 38 ÂșC on any single occasion), Hematoma (Spontaneous drainage), Deep vein thrombosis, Cervical stump problems, Minor anaesthesia problems, Others Perioperative and the periode 12 months after the prosedure Yes
Secondary Frequency of menopause Values are given as n (%)and serum levels of ostradiol, FSH, LH, AMH 12 months after surgery No
Secondary Frequency of adenomyosis in specimen from the operation. Frequency of adenomyosis in specimen from the operation. Values are given as n (%). postoperative No
Secondary Frequency and grade of genital prolapse Frequency and grade of genital prolapse 60 and 120 months after procedure(POP-Q). Values are given as n (%) Type of prolapse is specified according to POP-Q Staging Criteria 0-IV and as cystocele, rectocele, enterocele, vault prolapse or combined prolapse. 60 and 120 months after procedure No
Secondary Volume of uterine corpus preoperative, location and size of fibromas, Weight of the removed uterus/uterine corpus. Volume of the uterine corpus preoperative (cm3). Values are given as median (range) or mean (sd). Size and location of fibromas preoperative (cm). Values are given as median (range) or mean (sd), and is specified by location. Weight of the removed uterus/uterine corpus (g). Values are given as median (range) or mean (sd). Pre- and perioperative No
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