Long Term Outcomes Following Total Laparoscopic Hysterectomy and Laparoscopic Supracervical Hysterectomy
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|ClinicalTrials.gov Identifier: NCT01289314|
Recruitment Status : Unknown
Verified February 2011 by Oslo University Hospital.
Recruitment status was: Recruiting
First Posted : February 3, 2011
Last Update Posted : February 10, 2011
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.
|Condition or disease||Intervention/treatment|
|Total Laparoscopic Hysterectomy Laparoscopic Supracervical Hysterectomy Fibromas Abnormal Uterine Bleeding Dysmenorrhea||Procedure: TLH Procedure: Laparoscopic supracervical hysterectomy|
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 (Clinical Trial)|
|Estimated Enrollment :||62 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Comparison of Long Term Outcomes Following Total Laparoscopic Hysterectomy and Laparoscopic Supracervical Hysterectomy.|
|Study Start Date :||February 2011|
|Estimated Primary Completion Date :||December 2011|
|Estimated Study Completion Date :||December 2012|
|Active Comparator: Total laparoscopic hysterectomy||
Total laparoscopic hysterectomy (TLH)
|Active Comparator: Laparoscopic supracervical hysterectomy||
Procedure: Laparoscopic supracervical hysterectomy
Laparoscopic supracervical hysterectomy (LSH)
- Pelvic pain reduction after the procedure. Occurrence and intensity of pelvic pain after the procedure. [ Time Frame: 12 months after the procedure ]10-point visual analogue scale. Values are given as median (range), mean (sd) or n (%).
- Patient satisfaction after the procedure [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 12 months after the procedure ]SF 36, Values are given as median (range) or mean (sd).
- Frequency of perioperative and postoperative complications. [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: postoperative ]Frequency of adenomyosis in specimen from the operation. Values are given as n (%).
- Frequency and grade of genital prolapse [ Time Frame: 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. [ Time Frame: 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01289314
|Contact: Espen Berner, MD||0047 firstname.lastname@example.org|
|Contact: Marit Lieng, MD, PHD||0047 email@example.com|
|Dept. of Gynecology, Oslo University Hospital||Recruiting|
|Contact: Espen Berner, MD 0047 22119800 firstname.lastname@example.org|
|Contact: Marit Lieng, MD PHD 0047 22119800 email@example.com|
|Principal Investigator: Espen Berner, MD|
|Study Director:||Marit Lieng, MD PHD||Dept. of Gynecology, Oslo University Hospital, Norway|