Long Term Outcomes Following Total Laparoscopic Hysterectomy and Laparoscopic Supracervical Hysterectomy

Dysmenorrhea Clinical Trial

Official title:

A Comparison of Long Term Outcomes Following Total Laparoscopic Hysterectomy and Laparoscopic Supracervical Hysterectomy.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01289314
• Other study ID #: LAP-HYST-TRIAL
• Status: Recruiting
• Phase: N/A
• First received: February 2, 2011
• Last updated: February 9, 2011
• Start date: February 2011
• Est. completion date: December 2012

Study information

• Verified date: February 2011
• Source: Oslo University Hospital
• Contact: Espen Berner, MD
• Phone: 0047 22119800
• Email: espen.berner[@]uus.no
• Is FDA regulated: No
• Health authority: Norway: Data Protection AuthorityNorway: Regional Ethics Commitee
• Study type: Interventional

Clinical 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.

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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: December 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abnormal Uterine Bleeding
• Dysmenorrhea
• Fibromas
• Laparoscopic Supracervical Hysterectomy
• Total Laparoscopic Hysterectomy
• Uterine Hemorrhage

Intervention

Procedure:
• TLH
Total laparoscopic hysterectomy (TLH)
• Laparoscopic supracervical hysterectomy
Laparoscopic supracervical hysterectomy (LSH)

Locations

Country	Name	City	State
Norway	Dept. of Gynecology, Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Patient satisfaction after the procedure	10-point visual analogue scale. Values are given as median (range) or mean (sd).	12 months after the procedure	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	Frequency of menopause	Values are given as n (%)and serum levels of ostradiol, FSH, LH, AMH	12 months after surgery	No
Secondary	Frequency of adenomyosis in specimen from the operation.	Frequency of adenomyosis in specimen from the operation. Values are given as n (%).	postoperative	No
Secondary	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	No
Secondary	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	No

External Links

•   Homepage of Oslo University Hospital