Clinical trial NCT01289314: Long Term Outcomes Following Total Laparoscopic Hysterectomy and Laparoscopic Supracervical Hysterectomy
Official title: A Comparison of Long Term Outcomes Following Total Laparoscopic Hysterectomy and Laparoscopic Supracervical Hysterectomy.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Total Laparoscopic Hysterectomy
Laparoscopic Supracervical Hysterectomy
Fibromas
Abnormal Uterine Bleeding
Dysmenorrhea
Keywords: total laparoscopic hysterectomy
laparoscopic supracervical hysterectomy
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2011-02-03
Enrollment: 62
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Pelvic pain reduction after the procedure. Occurrence and intensity of pelvic pain after the procedure.
timeFrame: 12 months after the procedure
Secondary outcomes:
measure: Patient satisfaction after the procedure
timeFrame: 12 months after the procedure
measure: Occurrence of vaginal bleeding after the procedure
timeFrame: 12 months after the procedure
measure: Improvement in patient Quality of Life after the procedure
timeFrame: 12 months after the procedure
measure: Frequency of perioperative and postoperative complications.
timeFrame: Perioperative and the periode 12 months after the prosedure
measure: Frequency of menopause
timeFrame: 12 months after surgery
measure: Frequency of adenomyosis in specimen from the operation.
timeFrame: postoperative
measure: Frequency and grade of genital prolapse
timeFrame: 60 and 120 months after procedure
measure: Volume of uterine corpus preoperative, location and size of fibromas, Weight of the removed uterus/uterine corpus.
timeFrame: Pre- and perioperative
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Dept. of Gynecology, Oslo University Hospital
Study officials:
affiliation: Dept. of Gynecology, Oslo University Hospital, Norway
name: Marit Lieng, MD PHD
role: STUDY_DIRECTOR
References: