Long Term Outcomes Following Total Laparoscopic Hysterectomy and Laparoscopic Supracervical Hysterectomy

Not Applicable

• Conditions: Total Laparoscopic Hysterectomy; Laparoscopic Supracervical Hysterectomy; Fibromas; Abnormal Uterine Bleeding; Dysmenorrhea

• Registration Number: NCT01289314
• Lead Sponsor: Oslo University Hospital

Brief 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.

Detailed 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).

Study Timeline

• Status Verified: 2011-02
• Study Start: 2011-02
• Study First Submitted: 2011-02-02
• Study First Submitted QC: 2011-02-02
• Study First Posted: 2011-02-03
• Last Update Submitted: 2011-02-09
• Last Update Posted: 2011-02-10
• Primary Completion: 2011-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 62

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pelvic pain reduction after the procedure. Occurrence and intensity of pelvic pain after the procedure.	12 months after the procedure	10-point visual analogue scale. Values are given as median (range), mean (sd) or n (%).

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction after the procedure	12 months after the procedure	10-point visual analogue scale. Values are given as median (range) or mean (sd).
Occurrence of vaginal bleeding after the procedure	12 months after the procedure	Values are given as no bleeding, n (%); cyclical bleeding, n (%); irregular bleeding, n (%); bleeding related to sexual activity, n (%).
Improvement in patient Quality of Life after the procedure	12 months after the procedure	SF 36, Values are given as median (range) or mean (sd).
Frequency of perioperative and postoperative complications.	Perioperative and the periode 12 months after the prosedure	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
Frequency of menopause	12 months after surgery	Values are given as n (%)and serum levels of ostradiol, FSH, LH, AMH
Frequency of adenomyosis in specimen from the operation.	postoperative	Frequency of adenomyosis in specimen from the operation. Values are given as n (%).
Frequency and grade of genital prolapse	60 and 120 months after procedure	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.
Volume of uterine corpus preoperative, location and size of fibromas, Weight of the removed uterus/uterine corpus.	Pre- and perioperative	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).

Trial Locations

Locations (1)

Dept. of Gynecology, Oslo University Hospital; 🇳🇴 Oslo, Norway