A Comparison of Long Term Outcomes Following Total Laparoscopic Hysterectomy and Laparoscopic Supracervical Hysterectomy.
N/A
N/A
Female
Total Laparoscopic Hysterectomy, Laparoscopic Supracervical Hysterectomy, Fibromas, Abnormal Uterine Bleeding, Dysmenorrhea
Trial Information
A Comparison of Long Term Outcomes Following Total Laparoscopic Hysterectomy and Laparoscopic Supracervical Hysterectomy.
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).
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
Pelvic pain reduction after the procedure. Occurrence and intensity of pelvic pain after the procedure.
Outcome Description:
10-point visual analogue scale. Values are given as median (range), mean (sd) or n (%).
Outcome Time Frame:
12 months after the procedure
Safety Issue:
No
Principal Investigator
Marit Lieng, MD PHD
Investigator Role:
Study Director
Investigator Affiliation:
Dept. of Gynecology, Oslo University Hospital, Norway
Authority:
Norway: Data Protection Authority
Study ID:
LAP-HYST-TRIAL
NCT ID:
NCT01289314
Start Date:
February 2011
Completion Date:
December 2012
Related Keywords:
- Total Laparoscopic Hysterectomy
- Laparoscopic Supracervical Hysterectomy
- Fibromas
- Abnormal Uterine Bleeding
- Dysmenorrhea
- total laparoscopic hysterectomy
- laparoscopic supracervical hysterectomy
- Dysmenorrhea
- Fibroma
- Hemorrhage
- Uterine Hemorrhage
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