NCT01537731

Brief Summary

Previous studies have shown that chronic pain after hysterectomy is common. The aim of this study is to investigate the incidence of chronic pain after vaginal or laparoscopic hysterectomy for benign reasons. The aim of this prospective study is also to study the role of anesthetics, surgery and other possible predictors for pain 6 months after hysterectomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
225

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2009

Longer than P75 for all trials

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

April 1, 2009

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 23, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

October 9, 2013

Status Verified

October 1, 2013

Enrollment Period

4.5 years

First QC Date

January 10, 2012

Last Update Submit

October 8, 2013

Conditions

Chronic Postsurgical Pain

Outcome Measures

Primary Outcomes (1)

  • Presence of persistent postsurgical pain as measured at 6 months after surgery.

    five years

Secondary Outcomes (2)

  • Severity, location, characteristics of persistent postsurgical pain.

    five years

  • Effect of postsurgical pain on activity, sleep.

    five years

Study Arms (1)

hysterectomy

Patient who previously underwent vaginal or laparoscopic hysterectomy

Procedure: vaginal or laparoscopic hysterectomy

Interventions

vaginal or laparoscopic hysterectomyPROCEDURE

vaginal hysterectomy or laparoscopic hysterectomy

hysterectomy

Eligibility Criteria

Age18 Years - 69 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Women who undergo vaginal or laparoscopic hysterectomy for benign conditions.

You may qualify if:

  • Patients who undergo vaginal or laparoscopic hysterectomy for benign conditions
  • Age 18-69 years
  • Gender: female
  • ASA status 1-3

You may not qualify if:

  • Body Mass Index over 35
  • Diabetes mellitus
  • Liver disease
  • Preoperative use of opioids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampere University Hospital

Tampere, 33521, Finland

Location

Related Publications (1)

  • Pokkinen SM, Nieminen K, Yli-Hankala A, Kalliomaki ML. Persistent posthysterectomy pain: A prospective, observational study. Eur J Anaesthesiol. 2015 Oct;32(10):718-24. doi: 10.1097/EJA.0000000000000318.

    PMID: 26258656DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

January 10, 2012

First Posted

February 23, 2012

Study Start

April 1, 2009

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

October 9, 2013

Record last verified: 2013-10

Locations

FI(1)