Long Term Outcomes Following Total Laparoscopic Hysterectomy and Laparoscopic Supracervical Hysterectomy

Study Overview
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Brief Summary
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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
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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).

Official Title
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A Comparison of Long Term Outcomes Following Total Laparoscopic Hysterectomy and Laparoscopic Supracervical Hysterectomy.

Conditions
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Total Laparoscopic Hysterectomy, Laparoscopic Supracervical Hysterectomy, Fibromas, Abnormal Uterine Bleeding, Dysmenorrhea

Intervention / Treatment
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* Procedure: TLH
* Procedure: Laparoscopic supracervical hysterectomy


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Total laparoscopic hysterectomy<br> | Procedure: TLH<br>* Total laparoscopic hysterectomy (TLH)<br>|
| Active Comparator: Laparoscopic supracervical hysterectomy<br> | Procedure: Laparoscopic supracervical hysterectomy<br>* Laparoscopic supracervical hysterectomy (LSH)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction after the procedure | 10-point visual analogue scale. Values are given as median (range) or mean (sd). | 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 (%). | 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). | 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 | 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 | 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 (%). | 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. | 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). | Pre- and perioperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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total laparoscopic hysterectomy, laparoscopic supracervical hysterectomy