To compare the quality of life after removal of the uterus by means of open (abdominal) or minimally invasive (laparoscopic) approach

ISRCTN ISRCTN15214439
DOI https://doi.org/10.1186/ISRCTN15214439
Secondary identifying numbers MMC2112
Submission date
17/09/2011
Registration date
09/11/2011
Last edited
21/05/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Theodoor E Nieboer
Scientific

Geert Grooteplein 10
Nijmegen
6500 HB
Netherlands

Phone +31 (0)62 455 5126
Email b.nieboer@obgyn.umcn.nl

Study information

Study designSingle-centre randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA randomized trial to compare the quality of life after removal of the uterus by means of open (abdominal) or minimally invasive (laparoscopic) approach
Study objectivesIt 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(s)Local Medical Ethical Committee of the Maxima Medical Centre Veldhoven, 25/07/2002, ref: METC-MMC 0217
Health condition(s) or problem(s) studiedBenign gynecological diseases such as bleeding disorders or dysmenorrhoea
InterventionAbdominal 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 typeProcedure/Surgery
Primary outcome measureQuality of life, measured 2, 4, 6 and 12 weeks post surgery by means of the Short Form 36 health survey
Secondary outcome measures1. Operation time
2. Blood loss
3. Hospital stay
Overall study start date01/08/2002
Completion date01/07/2009

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants59
Key inclusion criteriaPatients scheduled for hysterectomy for benign conditions in which a vaginal hysterectomy was not possible
Key exclusion criteria1. 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
Date of first enrolment01/08/2002
Date of final enrolment01/07/2009

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Geert Grooteplein 10
Nijmegen
6500 HB
Netherlands

Sponsor information

Maxima Medical Center (Netherlands)
Hospital/treatment centre

Postbus 7777
Veldhoven
5500 MB
Netherlands

ROR logo "ROR" https://ror.org/02x6rcb77

Funders

Funder type

Hospital/treatment centre

Maxima Medical Center (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/03/2007 Yes No
Results article results 01/01/2012 Yes No