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
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
-
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.
-
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.