Vaginal Hysterectomy, Laparoscopic Hysterectomy, Postoperative Pain

NCT ID: NCT01442961

Last Updated: 2013-04-10

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

COMPLETED

Clinical Phase

NA

Total Enrollment

188 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2013-03-31

Brief Summary

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The previous studies have shown that recovery after laparoscopic or vaginal hysterectomy is faster than after abdominal approach. The aim of this study is to evaluate postoperative pain after vaginal or laparoscopic hysterectomy. The primary outcome measurement is opioid consumption.

Detailed Description

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Conditions

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Postoperative Pain

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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laparoscopy

Intervention: Procedure: laparoscopy

Group Type ACTIVE_COMPARATOR

laparoscopy, laparoscopic hysterectomy

Intervention Type PROCEDURE

laparoscopic hysterectomy

vaginal

Intervention: Procedure: vaginal

Group Type ACTIVE_COMPARATOR

vaginal : vaginal hysterectomy

Intervention Type PROCEDURE

Vaginal hysterectomy

Interventions

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laparoscopy, laparoscopic hysterectomy

laparoscopic hysterectomy

Intervention Type PROCEDURE

vaginal : vaginal hysterectomy

Vaginal hysterectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age 18 -69 years
* Gender . female
* ASA status 1-3
* Vaginal hysterectomy or laparoscopic hysterectomy

Exclusion Criteria

* Body mass Index over 35
* Diabetes Mellitus
* Liver disease
* Allergies to pharmaceuticals used in the Study
* Present use of opioids
* Vaginal prolapse
Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Tampere University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Arvi Yli-Hankala

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tampere University Hospital

Tampere, , Finland

Site Status

Countries

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Finland

Other Identifiers

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R09003

Identifier Type: -

Identifier Source: org_study_id

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