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Long Term Outcomes Following Total Laparoscopic Hysterectomy and Laparoscopic Supracervical Hysterectomy

Primary Purpose

Total Laparoscopic Hysterectomy, Laparoscopic Supracervical Hysterectomy, Fibromas

Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
TLH
Laparoscopic supracervical hysterectomy
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Total Laparoscopic Hysterectomy focused on measuring total laparoscopic hysterectomy, laparoscopic supracervical hysterectomy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Dept. of Gynecology, Oslo University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Total laparoscopic hysterectomy

Laparoscopic supracervical hysterectomy

Arm Description

Outcomes

Primary Outcome Measures

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 (%).

Secondary Outcome Measures

Patient satisfaction after the procedure
10-point visual analogue scale. Values are given as median (range) or mean (sd).
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 (%).
Improvement in patient Quality of Life after the procedure
SF 36, Values are given as median (range) or mean (sd).
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
Frequency of menopause
Values are given as n (%)and serum levels of ostradiol, FSH, LH, AMH
Frequency of adenomyosis in specimen from the operation.
Frequency of adenomyosis in specimen from the operation. Values are given as n (%).
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.
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).

Full Information

First Posted
February 2, 2011
Last Updated
February 9, 2011
Sponsor
Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01289314
Brief Title
Long Term Outcomes Following Total Laparoscopic Hysterectomy and Laparoscopic Supracervical Hysterectomy
Official Title
A Comparison of Long Term Outcomes Following Total Laparoscopic Hysterectomy and Laparoscopic Supracervical Hysterectomy.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Unknown status
Study Start Date
February 2011 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Oslo University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Total Laparoscopic Hysterectomy, Laparoscopic Supracervical Hysterectomy, Fibromas, Abnormal Uterine Bleeding, Dysmenorrhea
Keywords
total laparoscopic hysterectomy, laparoscopic supracervical hysterectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Total laparoscopic hysterectomy
Arm Type
Active Comparator
Arm Title
Laparoscopic supracervical hysterectomy
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
TLH
Intervention Description
Total laparoscopic hysterectomy (TLH)
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic supracervical hysterectomy
Intervention Description
Laparoscopic supracervical hysterectomy (LSH)
Primary Outcome Measure Information:
Title
Pelvic pain reduction after the procedure. Occurrence and intensity of pelvic pain after the procedure.
Description
10-point visual analogue scale. Values are given as median (range), mean (sd) or n (%).
Time Frame
12 months after the procedure
Secondary Outcome Measure Information:
Title
Patient satisfaction after the procedure
Description
10-point visual analogue scale. Values are given as median (range) or mean (sd).
Time Frame
12 months after the procedure
Title
Occurrence of vaginal bleeding after the procedure
Description
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
Title
Improvement in patient Quality of Life after the procedure
Description
SF 36, Values are given as median (range) or mean (sd).
Time Frame
12 months after the procedure
Title
Frequency of perioperative and postoperative complications.
Description
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
Title
Frequency of menopause
Description
Values are given as n (%)and serum levels of ostradiol, FSH, LH, AMH
Time Frame
12 months after surgery
Title
Frequency of adenomyosis in specimen from the operation.
Description
Frequency of adenomyosis in specimen from the operation. Values are given as n (%).
Time Frame
postoperative
Title
Frequency and grade of genital prolapse
Description
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
Title
Volume of uterine corpus preoperative, location and size of fibromas, Weight of the removed uterus/uterine corpus.
Description
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

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Espen Berner, MD
Phone
0047 22119800
Email
espen.berner@uus.no
First Name & Middle Initial & Last Name or Official Title & Degree
Marit Lieng, MD, PHD
Phone
0047 22119800
Email
marit.lieng@uus.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marit Lieng, MD PHD
Organizational Affiliation
Dept. of Gynecology, Oslo University Hospital, Norway
Official's Role
Study Director
Facility Information:
Facility Name
Dept. of Gynecology, Oslo University Hospital
City
Oslo
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Espen Berner, MD
Phone
0047 22119800
Email
espen.berner@uus.no
First Name & Middle Initial & Last Name & Degree
Marit Lieng, MD PHD
Phone
0047 22119800
Email
marit.lieng@uus.no
First Name & Middle Initial & Last Name & Degree
Espen Berner, MD

12. IPD Sharing Statement

Links:
URL
http://www.oslo-universitetssykehus.no
Description
Homepage of Oslo University Hospital

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Long Term Outcomes Following Total Laparoscopic Hysterectomy and Laparoscopic Supracervical Hysterectomy

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