Long Term Outcomes Following Total Laparoscopic Hysterectomy and Laparoscopic Supracervical Hysterectomy

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.

Study Overview

• Status: Unknown
• Conditions: Dysmenorrhea; Total Laparoscopic Hysterectomy; Abnormal Uterine Bleeding; Laparoscopic Supracervical Hysterectomy; Fibromas
• Intervention / Treatment: Procedure: TLH; Procedure: Laparoscopic supracervical hysterectomy

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 Type: Interventional
• Enrollment (Anticipated): 62
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Espen Berner, MD; Phone Number: 0047 22119800; Email: espen.berner@uus.no
• Study Contact Backup: Name: Marit Lieng, MD, PHD; Phone Number: 0047 22119800; Email: marit.lieng@uus.no

Study Locations

• Norway
  • Oslo, Norway
    • Recruiting
    • Dept. of Gynecology, Oslo University Hospital
    • Principal Investigator: Espen Berner, MD
    • Contact: Espen Berner, MD; Phone Number: 0047 22119800; Email: espen.berner@uus.no
    • Contact: Marit Lieng, MD PHD; Phone Number: 0047 22119800; Email: marit.lieng@uus.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Total laparoscopic hysterectomy	Procedure: TLH; Total laparoscopic hysterectomy (TLH)
Active Comparator: Laparoscopic supracervical hysterectomy	Procedure: Laparoscopic supracervical hysterectomy; Laparoscopic supracervical hysterectomy (LSH)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 (%).	12 months after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction after the procedure	10-point visual analogue scale. Values are given as median (range) or mean (sd).	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 (%).	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).	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	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	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 (%).	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.	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).	Pre- and perioperative

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Study Director: Marit Lieng, MD PHD, Dept. of Gynecology, Oslo University Hospital, Norway

Publications and helpful links

Helpful Links

• Homepage of Oslo University Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Anticipated): December 1, 2011
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: February 2, 2011
• First Submitted That Met QC Criteria: February 2, 2011
• First Posted (Estimate): February 3, 2011

Study Record Updates

• Last Update Posted (Estimate): February 10, 2011
• Last Update Submitted That Met QC Criteria: February 9, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Keywords: total laparoscopic hysterectomy; laparoscopic supracervical hysterectomy
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Pain; Neurologic Manifestations; Uterine Diseases; Hemorrhage; Neoplasms, Connective Tissue; Menstruation Disturbances; Pelvic Pain; Neoplasms, Fibrous Tissue; Dysmenorrhea; Fibroma; Uterine Hemorrhage
• Other Study ID Numbers: LAP-HYST-TRIAL