Long Term Outcomes Following Total Laparoscopic Hysterectomy and Laparoscopic Supracervical Hysterectomy

NCT ID: NCT01289314

Last Updated: 2011-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-12-31

Brief Summary

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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

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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

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Total Laparoscopic Hysterectomy Laparoscopic Supracervical Hysterectomy Fibromas Abnormal Uterine Bleeding Dysmenorrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Total laparoscopic hysterectomy

Group Type ACTIVE_COMPARATOR

TLH

Intervention Type PROCEDURE

Total laparoscopic hysterectomy (TLH)

Laparoscopic supracervical hysterectomy

Group Type ACTIVE_COMPARATOR

Laparoscopic supracervical hysterectomy

Intervention Type PROCEDURE

Laparoscopic supracervical hysterectomy (LSH)

Interventions

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TLH

Total laparoscopic hysterectomy (TLH)

Intervention Type PROCEDURE

Laparoscopic supracervical hysterectomy

Laparoscopic supracervical hysterectomy (LSH)

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dept. of Gynecology, Oslo University Hospital

Principal Investigators

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Marit Lieng, MD PHD

Role: STUDY_DIRECTOR

Dept. of Gynecology, Oslo University Hospital, Norway

Locations

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Dept. of Gynecology, Oslo University Hospital

Oslo, Oslo County, Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Espen Berner, MD

Role: CONTACT

0047 22119800

Marit Lieng, MD, PHD

Role: CONTACT

0047 22119800

Facility Contacts

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Espen Berner, MD

Role: primary

0047 22119800

Marit Lieng, MD PHD

Role: backup

0047 22119800

Related Links

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http://www.oslo-universitetssykehus.no

Homepage of Oslo University Hospital

Other Identifiers

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LAP-HYST-TRIAL

Identifier Type: -

Identifier Source: org_study_id

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