NCT01442961

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
188

participants targeted

Target at P75+ for not_applicable postoperative-pain

Timeline
Completed

Started Jan 2009

Longer than P75 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2011

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 29, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

April 10, 2013

Status Verified

April 1, 2013

Enrollment Period

4.2 years

First QC Date

September 19, 2011

Last Update Submit

April 9, 2013

Conditions

Postoperative Pain

Keywords

pain, postoperativehysterectomy, vaginalsurgery, gynecological

Outcome Measures

Primary Outcomes (1)

  • Postoperative consumption of an opioid (oxycodone)

    the consumption of oxycodone will be monitored by recording the amount of the drug received via a commercially available patient controlled analgesia (PCA) pump

    20 hours

Secondary Outcomes (1)

  • NRS (numeral rating scale) of pain

    20 hours

Study Arms (2)

laparoscopy

ACTIVE COMPARATOR

Intervention: Procedure: laparoscopy

Procedure: laparoscopy, laparoscopic hysterectomy

vaginal

ACTIVE COMPARATOR

Intervention: Procedure: vaginal

Procedure: vaginal : vaginal hysterectomy

Interventions

laparoscopy, laparoscopic hysterectomyPROCEDURE

laparoscopic hysterectomy

laparoscopy
vaginal : vaginal hysterectomyPROCEDURE

Vaginal hysterectomy

vaginal

Eligibility Criteria

Age18 Years - 69 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampere University Hospital

Tampere, Finland

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

LaparoscopyHysterectomy, Vaginal

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeHysterectomyGynecologic Surgical ProceduresUrogenital Surgical Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

September 19, 2011

First Posted

September 29, 2011

Study Start

January 1, 2009

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

April 10, 2013

Record last verified: 2013-04

Locations

FI(1)