Clinical Trials Directory

Trials / Unknown

UnknownNCT01289314

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.

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
62 (estimated)
Sponsor
Oslo University Hospital · Academic / Other
Sex
Female
Age
—
Healthy volunteers
Not accepted

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).

Conditions

Interventions

TypeNameDescription
PROCEDURETLHTotal laparoscopic hysterectomy (TLH)
PROCEDURELaparoscopic supracervical hysterectomyLaparoscopic supracervical hysterectomy (LSH)

Timeline

Start date
2011-02-01
Primary completion
2011-12-01
Completion
2012-12-01
First posted
2011-02-03
Last updated
2011-02-10

Locations

1 site across 1 country: Norway

Source: ClinicalTrials.gov record NCT01289314. Inclusion in this directory is not an endorsement.