Total Laparoscopic HysterectomyNCT01289314
Long Term Outcomes Following Total Laparoscopic Hysterectomy and Laparoscopic Supracervical Hysterectomy
A study testing TLH and Laparoscopic supracervical hysterectomy in people with Total Laparoscopic Hysterectomy and Laparoscopic Supracervical Hysterectomy, run by Oslo University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Total Laparoscopic Hysterectomy, Laparoscopic Supracervical Hysterectomy, Fibromas
- What is being tested?
- TLH and Laparoscopic supracervical hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2011to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Premenopausal women who are referred to the department
- benign condition requiring hysterectomy
- Dysmenorrohea/cyclic pelvic pain
- Informed consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Dept. of Gynecology, Oslo University Hospital
Oslo, Oslo
Espen Berner, MD, 0047 22119800, espen.berner@uus.no
Marit Lieng, MD PHD, 0047 22119800, marit.lieng@uus.no
About this study
Official title: A Comparison of Long Term Outcomes Following Total Laparoscopic Hysterectomy and Laparoscopic Supracervical Hysterectomy.
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.
Read the 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).
- Conditions
- Total Laparoscopic Hysterectomy, Laparoscopic Supracervical Hysterectomy, Fibromas, Abnormal Uterine Bleeding, Dysmenorrhea
- Being tested
- TLH, Laparoscopic supracervical hysterectomy
- Keywords
- total laparoscopic hysterectomy, laparoscopic supracervical hysterectomy
- Medical subject headings
- Fibroma, Metrorrhagia, Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TLHProcedure or surgery
Total laparoscopic hysterectomy (TLH)
Laparoscopic supracervical hysterectomyProcedure or surgery
Laparoscopic supracervical hysterectomy (LSH)
| Study group | Role | What they receive |
|---|---|---|
| Total laparoscopic hysterectomy | Active comparator | Not described Receives: Procedure: TLH |
| Laparoscopic supracervical hysterectomy | Active comparator | Not described Receives: Procedure: Laparoscopic supracervical hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (%).
Measured: 12 months after the procedure
Secondary outcomes (8)
Patient satisfaction after the procedure
10-point visual analogue scale. Values are given as median (range) or mean (sd).
Measured: 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 (%).
Measured: 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).
Measured: 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
Measured: 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
Measured: 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 (%).
Measured: 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.
Measured: 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).
Measured: Pre- and perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionDec 2011 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Laparoscopic HysterectomyStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Marit Lieng, MD PHD, Study director, Dept. of Gynecology, Oslo University Hospital, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01289314
- Sponsor's protocol ID
- LAP-HYST-TRIAL
- Status last verified
- Feb 2011
- First submitted
- 2 Feb 2011
- Last updated
- 10 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Long Term Outcomes Following Total Laparoscopic Hysterectomy and Laparoscopic Supracervical Hysterectomy.
- ClinicalTrials.gov ID
- NCT01289314
- Acronym / sponsor ID
- LAP-HYST-TRIAL
- Conditions
- Total Laparoscopic Hysterectomy, Laparoscopic Supracervical Hysterectomy, Fibromas, Abnormal Uterine Bleeding, Dysmenorrhea
- Keywords
- total laparoscopic hysterectomy, laparoscopic supracervical hysterectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 3 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total laparoscopic hysterectomy | Active comparator | Procedure: TLH |
| Laparoscopic supracervical hysterectomy | Active comparator | Procedure: Laparoscopic supracervical hysterectomy |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Premenopausal women who are referred to the department
- benign condition requiring hysterectomy
- Dysmenorrohea/cyclic pelvic pain
- Informed consent
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TLHTotal laparoscopic hysterectomy (TLH) | Procedure or surgery | Total laparoscopic hysterectomy |
| Laparoscopic supracervical hysterectomyLaparoscopic supracervical hysterectomy (LSH) | Procedure or surgery | Laparoscopic supracervical hysterectomy |
Primary outcome
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 (%).
8 secondary outcomes
Patient satisfaction after the procedure
Time frame: 12 months after the procedure
Occurrence of vaginal bleeding after the procedure
Time frame: 12 months after the procedure
Improvement in patient Quality of Life after the procedure
Time frame: 12 months after the procedure
Frequency of perioperative and postoperative complications.
Time frame: Perioperative and the periode 12 months after the prosedure
Frequency of menopause
Time frame: 12 months after surgery
Frequency of adenomyosis in specimen from the operation.
Time frame: postoperative
Frequency and grade of genital 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.
Time frame: Pre- and perioperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2011.
- Homepage of Oslo University HospitalLink provided by the sponsor.
Related trials for Total Laparoscopic Hysterectomy
Not yet recruiting
COMPARISON OF THE POSTOPERATIVE ANALGESIC EFFECTS OF ULTRASOUND-GUIDED QUADRO-ILIAC PLANE AND TRANSVERSUS ABDOMINIS PLANE BLOCKS IN PATIENTS UNDERGOING TOTAL LAPAROSCOPIC HYSTERECTOMY
Postoperative Pain Following Total Laparoscopic Hysterectomy
Not yet recruitingPhase 1/2
Long-acting Local Vaginal Cuff Anesthesia Following Hysterectomy
Pain, Postoperative
Not yet recruiting
Ureterolysis in Laparoscopic Total Hysterectomy: Routine Approach
Hysterectomy, Laparoscopic Surgery
Not yet recruiting
Routine Versus Selective Ureterolysis During Total Laparoscopic Hysterectomy for Benign Conditions
Total Laparoscopic Hysterectomy
RecruitingObservational study
Performance of SYMMCORA® vs. V-Loc® Suture Material in Patients Undergoing Laparoscopic Total Hysterectomy
Abnormal Uterine Bleeding, Endometriosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marit Lieng, MD PHD study director
Dept. of Gynecology, Oslo University Hospital, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TLH and Laparoscopic supracervical hysterectomy in people with Total Laparoscopic Hysterectomy and Laparoscopic Supracervical Hysterectomy, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Espen Berner, MD (0047 22119800, espen.berner@uus.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic pain reduction after the procedure. Occurrence and intensity of pelvic pain after the procedure. (time frame: 12 months after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2011.