An interventional study of TLH and Laparoscopic supracervical hysterectomy in Total Laparoscopic Hysterectomy, Laparoscopic Supracervical Hysterectomy and Fibromas, sponsored by Oslo University Hospital. Status unknown at 1 site in Norway. Open to female participants. Per ClinicalTrials.gov, last updated 2011-02-10.
Sponsored by Oslo University Hospital · Not applicable, Interventional, and Treatment
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).
19 studies on the registry are indexed under Fibroma; 4 are open to participants now.
This study's planned enrollment of 62 is close to the median of 62 across 13 interventional studies indexed under Fibroma.
Browse Fibroma studies →Oslo University Hospital is the lead sponsor of 834 studies on the registry; 149 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: TLH
Procedure: Laparoscopic supracervical hysterectomy
Total laparoscopic hysterectomy (TLH)
Laparoscopic supracervical hysterectomy (LSH)
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 (%).
Time frame: 12 months after the procedure
Patient satisfaction after the procedure
10-point visual analogue scale. Values are given as median (range) or mean (sd).
Time frame: 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 (%).
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: 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 (%).
Time frame: 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.
Time frame: 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).
Time frame: Pre- and perioperative
The record gives a start of Feb 2011, a primary completion of Dec 2011 and a completion of Dec 2012. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.
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