Long Term Outcomes Following Total Laparoscopic Hysterectomy and Laparoscopic Supracervical Hysterectomy

University of Oslo (UIO)

Status

Unknown

Conditions

Fibromas

Total Laparoscopic Hysterectomy

Dysmenorrhea

Laparoscopic Supracervical Hysterectomy

Abnormal Uterine Bleeding

Treatments

Procedure: TLH

Procedure: Laparoscopic supracervical hysterectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT01289314

LAP-HYST-TRIAL

Details and patient eligibility

About

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.

Full 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).

Enrollment

62 estimated patients

Sex

Female

Volunteers

No 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.