Condition category
Urological and Genital Diseases
Date applied
17/09/2011
Date assigned
09/11/2011
Last edited
21/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Hysterectomy (removal of the uterus) is the most frequently performed gynecological operation. In abdominal hysterectomy, the uterus is removed through a 10-14 cm cut (incision) in the abdomen. In laparoscopic hysterectomy, small instruments and a camera are introduced into the abdomen through 3-4 small incisions of less than 1 cm each. Using these instruments, the uterus can be released from the surrounding tissues and blood supply and can be removed through the vagina. Laparoscopic hysterectomy might be better for patients in terms of pain, hospital stay, blood loss and cosmetic results. We want to find out if there are benefits 4 years after surgery.

Who can participate?
Women scheduled for hysterectomy for benign (non-cancerous) disease.

What does the study involve?
The participants were randomly allocated to undergo either abdominal or laparoscopic hysterectomy. Operation time, blood loss, pain and number of days in the hospital were recorded. Participants were asked to fill in a quality of life questionnaire 2, 4, 6 and 12 weeks and 4 years after the surgery.

What are the possible benefits and risks of participating?
This study will help us find out whether there is any long-term advantage of laparoscopic hysterectomy over abdominal hysterectomy.

Where is the study run from?
Maxima Medical Center in Veldhoven, Netherlands.

When is the study starting and how long is it expected to run for?
The study started in 2002 and ran for about 2 years.

Who is funding the study?
Maxima Medical Center, Netherlands.

Who is the main contact?
Dr Th. E. Nieboer
b.nieboer@obgyn.umcn.nl

Trial website

Contact information

Type

Scientific

Primary contact

Dr Theodoor E Nieboer

ORCID ID

Contact details

Geert Grooteplein 10
Nijmegen
6500 HB
Netherlands
+31 (0)62 455 5126
b.nieboer@obgyn.umcn.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MMC2112

Study information

Scientific title

A randomized trial to compare the quality of life after removal of the uterus by means of open (abdominal) or minimally invasive (laparoscopic) approach

Acronym

Study hypothesis

It is expected that quality of life is better after laparoscopic than after abdominal hysterectomy. This study with a long term follow-up of 4 years was conducted to evaluate whether any long term differences would remain between the two approached.

Ethics approval

Local Medical Ethical Committee of the Maxima Medical Centre Veldhoven, 25/07/2002, ref: METC-MMC 0217

Study design

Single-centre randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Benign gynecological diseases such as bleeding disorders or dysmenorrhoea

Intervention

Abdominal versus laparoscopic hysterectomy.

Abdominal hysterectomies were performed through a transverse (Pfannenstiel) incision and surgery was carried by means of the standard extrafascial technique.

Laparoscopic hysterectomies were all intentionally total laparoscopic hysterectomy. This means that the whole procedure was carried out laparoscopically, except the removal of the uterus, which was carried out via the vagina.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Quality of life, measured 2, 4, 6 and 12 weeks post surgery by means of the Short Form 36 health survey

Secondary outcome measures

1. Operation time
2. Blood loss
3. Hospital stay

Overall trial start date

01/08/2002

Overall trial end date

01/07/2009

Reason abandoned

Eligibility

Participant inclusion criteria

Patients scheduled for hysterectomy for benign conditions in which a vaginal hysterectomy was not possible

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

59

Participant exclusion criteria

1. Size of the uterus greater than 18 weeks gestation
2. A suspicion of malignancy
3. A previous lower midline incision
4. The need for simultaneous interventions like prolapse repair
5. Inability to speak Dutch
6. Furthermore, patients using antidepressant drugs or with a history of psychiatric disease or other severe medical issues

Recruitment start date

01/08/2002

Recruitment end date

01/07/2009

Locations

Countries of recruitment

Netherlands

Trial participating centre

Geert Grooteplein 10
Nijmegen
6500 HB
Netherlands

Sponsor information

Organisation

Maxima Medical Center (Netherlands)

Sponsor details

Postbus 7777
Veldhoven
5500 MB
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Maxima Medical Center (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17368247
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22183215

Publication citations

  1. Results

    Kluivers KB, Hendriks JC, Mol BW, Bongers MY, Bremer GL, de Vet HC, Vierhout ME, Brolmann HA, Quality of life and surgical outcome after total laparoscopic hysterectomy versus total abdominal hysterectomy for benign disease: a randomized, controlled trial., J Minim Invasive Gynecol, 14, 2, 145-152, doi: 10.1016/j.jmig.2006.08.009.

  2. Results

    Nieboer TE, Hendriks JC, Bongers MY, Vierhout ME, Kluivers KB, Quality of life after laparoscopic and abdominal hysterectomy: a randomized controlled trial., Obstet Gynecol, 2012, 119, 1, 85-91, doi: 10.1097/AOG.0b013e31823d3b00.

Additional files

Editorial Notes