Plain English Summary
Background and study aims
In western countries, caesarean rates are rising. A niche is a cavity that can develop at the site of an old caesarean section scar which occurs in approximately 60% of the women who had a caesarean section. A niche can cause abnormal uterine blood loss, intracavitary accumulation of fluid and inaccessibility of the uterine cavity (i.e. for intra-uterine insemination or embryo transfer). Surgical therapy can possibly reduce these complaints. In general a hysteroscopic resection (surgery using a thin telescope called a hysteroscope and no incision is made) and / or coagulation of the vessels in the niche will be sufficient. However, in case of a large niche, a laparoscopic resection (surgery in which only small incisions are made) and closure of the niche is preferred. It is assumed that in these cases the risk of bladder injury during hysteroscopic niche resection is too high.
The main aim is to study the effectiveness of laparoscopic niche resection in the treatment of niche-related bleeding disorders. Other aims are to study the effect of laparoscopic niche resection on menstrual pain, quality of life and fertility, on intracavitary accumulation of fluid and on niche characteristics.
Who can participate?
Women with niche-related abnormal uterine blood loss, dysmenorrhoea (painful periods) or accumulation of
intracavitary fluid with a residual myometrium (middle layer of the uterine wall) < 3mm
What does the study involve?
All patients will undergo surgery (laparoscopic niche resection) and will be followed up for 6 months after the surgery.
What are the possible benefits and risks of participating?
We expect that laparoscopic reconstruction of a niche will reduce prolonged menstrual bleeding, associated menstrual pain and as a consequence will improve related quality of life. In addition, we expect the laparoscopic niche reconstruction to reduce the accumulation of intra-uterine fluid. We additionally expect the reconstruction to increase the thickness of the remaining myometrium between the bladder and the niche. Risks of the intervention include bleeding and bladder injury during the surgery and incomplete niche reconstruction.
Where is the study run from?
VU University Medical Center (Netherlands).
When is the study starting and how long is it expected to run for?
The study started in September 2009 and will continue until December 2015.
Who is funding the study?
VU University Medical Center (Netherlands).
Who is the main contact?
Prof. Dr. H.A.M. Brolmann
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ABR: NL37922.029.11
Study information
Scientific title
The effect of the laparoscopic reconstruction of a caesarean scar (Niche): an observational pilot study
Acronym
LapNiche
Study hypothesis
Laparoscopic niche resection will reduce the complaints and possibly increase fertility chances in women with a niche with residual myometrium < 3 mm and complaints of abnormal uterine blood loss / dysmenorrhoea or intracavitary accumulation of fluid.
Ethics approval
Ethical Board VUmc, 02/10/2011, ref.:2011/297
Study design
Observational study of an intervention (prospective cohort study)
Primary study design
Observational
Secondary study design
Cohort study
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
Abnormal Uterine Bleeding / Niche resection
Intervention
This is an observational study of an intervention, laparoscopic niche resection.
There is only one study arm. The laparoscopic niche resection/reconstruction is an operative laparoscopy where the roof of the niche is resected and the myometrial wound closed in two layers with Vicryl. The operation is performed under hysteroscopic guidance and lasts about 2-3 hours. The patient is followed up for 6 months after the intervention. Symptoms of postmenstrual spotting are assessed and a transvaginal ultrasound is made and compared to baseline values.
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measure
Reduction of abnormal uterine blood loss in days, measured at baseline and after 3, 6, 9 and 12 months
Secondary outcome measures
1. Quality of life (SF36)
2. Dysmenorrhoe
3. Fertility/pregnancy
4. Intracavitary accumulation of fluid
All above outcomes measured at baseline and after 3, 6, 9 and 12 months
Overall trial start date
01/01/2009
Overall trial end date
31/01/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. A niche with residual myometrium < 3 mm (as measured with SIS / GIS)
2. Complaints of abnormal uterine blood loss, dysmenorrhoea or accumulation of intracavitary fluid
3. Premenopausal women aged above 18
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
50
Participant exclusion criteria
1. Pregnancy
2. Age below 18
3. Other disorders that may induce spotting [polyps (everywhere in the uterus/cervix are exclusion criteria except those in the niche)], fibroids, known atypical endometrial cells, cervical dysplasia, cervical or pelvic infection, assumed malignancy, irregular cycle (>35 days or intercycle variation of 2 weeks or more)
4. Contra-indications for spinal or general anaesthesia
Recruitment start date
01/01/2009
Recruitment end date
12/12/2015
Locations
Countries of recruitment
Netherlands
Trial participating centre
Department of Obstetrics and Gynaecology
Amsterdam
1007 MB
Netherlands
Sponsor information
Organisation
VU University Medical Center (Netherlands)
Sponsor details
C/O Prof. Dr. H.A.M. Brolmann
Department of Obstetrics and Gynaecology
Amsterdam
1007 MB
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Time of the researchers is paid by the institution VU University Medical Center (VUmc) (Netherlands).
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
As it is an observational study of usual care the direct costs are reimbursed by the insurance company.
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
Basic results (scientific)
Publication list