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
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
Scientific
Geert Grooteplein 10
Nijmegen
6500 HB
Netherlands
| Phone | +31 (0)62 455 5126 |
|---|---|
| b.nieboer@obgyn.umcn.nl |
Study information
| Study design | Single-centre randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 objectives | 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(s) | Local Medical Ethical Committee of the Maxima Medical Centre Veldhoven, 25/07/2002, ref: METC-MMC 0217 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/08/2002 |
| Completion date | 01/07/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 59 |
| Key inclusion criteria | Patients scheduled for hysterectomy for benign conditions in which a vaginal hysterectomy was not possible |
| Key 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 |
| Date of first enrolment | 01/08/2002 |
| Date of final enrolment | 01/07/2009 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
6500 HB
Netherlands
Sponsor information
Hospital/treatment centre
Postbus 7777
Veldhoven
5500 MB
Netherlands
"ROR" |
https://ror.org/02x6rcb77 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
