Long Term Outcomes Following Total Laparoscopic Hysterectomy and Laparoscopic Supracervical Hysterectomy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Oslo University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01289314
First received: February 2, 2011
Last updated: February 9, 2011
Last verified: February 2011
  Purpose

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 Intervention
Total Laparoscopic Hysterectomy
Laparoscopic Supracervical Hysterectomy
Fibromas
Abnormal Uterine Bleeding
Dysmenorrhea
Procedure: TLH
Procedure: Laparoscopic supracervical hysterectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Comparison of Long Term Outcomes Following Total Laparoscopic Hysterectomy and Laparoscopic Supracervical Hysterectomy.

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Pelvic pain reduction after the procedure. Occurrence and intensity of pelvic pain after the procedure. [ Time Frame: 12 months after the procedure ] [ Designated as safety issue: No ]
    10-point visual analogue scale. Values are given as median (range), mean (sd) or n (%).


Secondary Outcome Measures:
  • Patient satisfaction after the procedure [ Time Frame: 12 months after the procedure ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Values are given as n (%)and serum levels of ostradiol, FSH, LH, AMH

  • Frequency of adenomyosis in specimen from the operation. [ Time Frame: postoperative ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 62
Study Start Date: February 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Total laparoscopic hysterectomy Procedure: TLH
Total laparoscopic hysterectomy (TLH)
Active Comparator: Laparoscopic supracervical hysterectomy Procedure: Laparoscopic supracervical hysterectomy
Laparoscopic supracervical hysterectomy (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).

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01289314

Contacts
Contact: Espen Berner, MD 0047 22119800 espen.berner@uus.no
Contact: Marit Lieng, MD, PHD 0047 22119800 marit.lieng@uus.no

Locations
Norway
Dept. of Gynecology, Oslo University Hospital Recruiting
Oslo, Norway
Contact: Espen Berner, MD    0047 22119800    espen.berner@uus.no   
Contact: Marit Lieng, MD PHD    0047 22119800    marit.lieng@uus.no   
Principal Investigator: Espen Berner, MD         
Sponsors and Collaborators
Oslo University Hospital
Investigators
Study Director: Marit Lieng, MD PHD Dept. of Gynecology, Oslo University Hospital, Norway
  More Information

Additional Information:
No publications provided

Responsible Party: Espen Berner / Marit Lieng, Dept. of Gynecology, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01289314     History of Changes
Other Study ID Numbers: LAP-HYST-TRIAL
Study First Received: February 2, 2011
Last Updated: February 9, 2011
Health Authority: Norway: Data Protection Authority
Norway: Regional Ethics Commitee

Keywords provided by Oslo University Hospital:
total laparoscopic hysterectomy
laparoscopic supracervical hysterectomy

Additional relevant MeSH terms:
Dysmenorrhea
Fibroma
Hemorrhage
Uterine Hemorrhage
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Pain
Signs and Symptoms
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 22, 2014