Clinical Analysis of Pain After Hysterectomy

NCT01706549 | Completed Results

• 1 other identifier: R11190
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Patients undergone either laparoscopic or vaginal hysterectomy will called for a clinical examination 1-3 years after surgery, if they suffer from pain 6 months after surgery. The aims of the study are:

1. 1.to reveal whether the pain is postsurgical in nature, or if there are any other reasons for the pain.
2. 2.to reveal the type of pain, neuropathic, nociceptive or idiopathic.
3. 3.to reveal the impact of pain on quality of life.

Conditions

Postoperative Pain

Keywords

Chronic pain; Hysterectomy; Quality of life

Outcome Measures

Primary Outcomes (1)

• Type of Chronic Pain After Hysterectomy

  Number of participants with probable neuropathic, possible neuropathic, pain had subsided and other type of pain.

  1-3 years after hysterectomy

Secondary Outcomes (2)

• Quality of Life After Hysterectomy

  1-3 years after hysterectomy

• Is the Pain Due to Hysterectomy?

  1-3 years

Study Arms (1)

Posthysterectomy pain

Observational study on posthysterectomy pain

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women undergone hysterectomy for 1-3 years previously and suffering from persistent pain 6 months after surgery. The patients are invited to participate in this study, if they have participated in previous studies "Sevoflurane, Propofol, Postoperative pain" by Yli-Hankala and Pokkinen and study:" Vaginal hysterectomy, laparoscopic hysterectomy, postoperative pain" by Yli-Hankala and Pokkinen.

You may qualify if:

• hysterectomy 1-3 years previously
• suffering from pain 6months postsurgically

Sponsors & Collaborators

• Tampere University Hospital: lead

Study Sites (1)

Tampere University Hospital

Tampere, 33200, Finland

Location

MeSH Terms

Conditions

Pain, Postoperative; Chronic Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Limitations and Caveats

Low participation rate. Inadequate filling of questionnaires. Time from surgery to clinical examination varied from 10 to 44 months. No preoperative quality of life measure.

Results Point of Contact

• Title: MD Satu Pokkinen
• Organization: Tampere University Hospital

Satu.pokkinen@pshp.fi

+3583311611

Study Officials

• Satu Pokkinen, MD

  Tampere University Hospital

  PRINCIPAL INVESTIGATOR

• Maija-Liisa Kalliomäki, MD, PhD

  Tampere University Hospital

  STUDY DIRECTOR

• Kari Nieminen, MD, Doc

  Tampere University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2012
• First Posted: October 15, 2012
• Study Start: March 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 13, 2017
• Results First Posted: June 2, 2015

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)