Condition category
Urological and Genital Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

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

Trial website

Contact information



Primary contact

Dr Theodoor E Nieboer


Contact details

Geert Grooteplein 10
6500 HB
+31 (0)62 455 5126

Additional identifiers

EudraCT number number

Protocol/serial number


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


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


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

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


Benign gynecological diseases such as bleeding disorders or dysmenorrhoea


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



Drug names

Primary outcome measure

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


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

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

Participant type


Age group




Target number of participants


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


Recruitment end date



Countries of recruitment


Trial participating centre

Geert Grooteplein 10
6500 HB

Sponsor information


Maxima Medical Center (Netherlands)

Sponsor details

Postbus 7777
5500 MB

Sponsor type

Hospital/treatment centre



Funder type

Hospital/treatment centre

Funder name

Maxima Medical Center (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Basic results (scientific)

Publication list

1. 2007 results in
2. 2012 results in

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