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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
62
Total laparoscopic hysterectomy (TLH)
Laparoscopic supracervical hysterectomy (LSH)
Dept. of Gynecology, Oslo University Hospital
Oslo, Oslo County, Norway
RECRUITINGPelvic 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 (%).
Time frame: 12 months after the procedure
Patient satisfaction after the procedure
10-point visual analogue scale. Values are given as median (range) or mean (sd).
Time frame: 12 months after the procedure
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 (%).
Time frame: 12 months after the procedure
Improvement in patient Quality of Life after the procedure
SF 36, Values are given as median (range) or mean (sd).
Time frame: 12 months after the procedure
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 ºC on any single occasion), Hematoma (Spontaneous drainage), Deep vein thrombosis, Cervical stump problems, Minor anaesthesia problems, Others
Time frame: Perioperative and the periode 12 months after the prosedure
Frequency of menopause
Values are given as n (%)and serum levels of ostradiol, FSH, LH, AMH
Time frame: 12 months after surgery
Frequency of adenomyosis in specimen from the operation.
Frequency of adenomyosis in specimen from the operation. Values are given as n (%).
Time frame: postoperative
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.
Time frame: 60 and 120 months after procedure
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).
Time frame: Pre- and perioperative
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