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

Open (Enrolling)
Total Laparoscopic Hysterectomy, Laparoscopic Supracervical Hysterectomy, Fibromas, Abnormal Uterine Bleeding, Dysmenorrhea

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Trial Information

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

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).

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

- Women with deep infiltrating endometriosis.

Type of Study:


Study Design:

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

Outcome Measure:

Pelvic pain reduction after the procedure. Occurrence and intensity of pelvic pain after the procedure.

Outcome Description:

10-point visual analogue scale. Values are given as median (range), mean (sd) or n (%).

Outcome Time Frame:

12 months after the procedure

Safety Issue:


Principal Investigator

Marit Lieng, MD PHD

Investigator Role:

Study Director

Investigator Affiliation:

Dept. of Gynecology, Oslo University Hospital, Norway


Norway: Data Protection Authority

Study ID:




Start Date:

February 2011

Completion Date:

December 2012

Related Keywords:

  • Total Laparoscopic Hysterectomy
  • Laparoscopic Supracervical Hysterectomy
  • Fibromas
  • Abnormal Uterine Bleeding
  • Dysmenorrhea
  • total laparoscopic hysterectomy
  • laparoscopic supracervical hysterectomy
  • Dysmenorrhea
  • Fibroma
  • Hemorrhage
  • Uterine Hemorrhage