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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Total laparoscopic hysterectomy | Active Comparator |
| |
| Laparoscopic supracervical hysterectomy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TLH | Procedure | Total laparoscopic hysterectomy (TLH) |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Espen Berner, MD | Contact | 0047 22119800 | espen.berner@uus.no | |
| Marit Lieng, MD, PHD | Contact | 0047 22119800 | marit.lieng@uus.no |
| Name | Affiliation | Role |
|---|---|---|
| Marit Lieng, MD PHD | Dept. of Gynecology, Oslo University Hospital, Norway | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Gynecology, Oslo University Hospital | Recruiting | Oslo | Oslo | Norway |
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| Label | URL |
|---|---|
| Homepage of Oslo University Hospital | View source |
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| Laparoscopic supracervical hysterectomy |
| Procedure |
Laparoscopic supracervical hysterectomy (LSH) |
|
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 |
| ID | Term |
|---|---|
| D005350 | Fibroma |
| D008796 | Metrorrhagia |
| D004412 | Dysmenorrhea |
| ID | Term |
|---|---|
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D014592 | Uterine Hemorrhage |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008599 | Menstruation Disturbances |
| D017699 | Pelvic Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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