The effect of the laparoscopic reconstruction of a caesarean scar (Niche)

ISRCTN	ISRCTN02271575
DOI	https://doi.org/10.1186/ISRCTN02271575
Secondary identifying numbers	ABR: NL37922.029.11

Submission date: 23/04/2013
Registration date: 27/02/2014
Last edited: 14/09/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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 the case of a large niche, a laparoscopic resection (surgery in which only small incisions are made) and closure of the niche are 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, intracavitary accumulation of fluid and niche characteristics.

Who can participate?
Women with niche-related abnormal uterine blood loss, dysmenorrhoea (painful periods) or accumulation of intracavitary fluid with 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, and 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, h.brolmann@vumc.nl

Contact information

Prof H.A.M. Brölmann
Scientific

Department of Obstetrics and Gynaecology
VU University Medical Center
Postbus 7057
Amsterdam
1007 MB
Netherlands

Study information

Study design	Observational study of an intervention (prospective cohort study)
Primary study design	Observational
Secondary study design	Cohort study
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	The effect of the laparoscopic reconstruction of a caesarean scar (Niche): an observational pilot study
Study acronym	LapNiche
Study objectives	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(s)	Ethical Board VUmc, 02/10/2011, ref.:2011/297
Health condition(s) or problem(s) studied	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 is 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
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 study start date	01/01/2009
Completion date	31/01/2018

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	50
Total final enrolment	133
Key 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
Key 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
Date of first enrolment	01/01/2009
Date of final enrolment	12/12/2015

Locations

Countries of recruitment

Netherlands

Study participating centre

Department of Obstetrics and Gynaecology

Amsterdam
1007 MB
Netherlands

Sponsor information

VU University Medical Center (Netherlands)
Hospital/treatment centre

C/O Prof. Dr. H.A.M. Brolmann
Department of Obstetrics and Gynaecology
Amsterdam
1007 MB
Netherlands

Website	http://www.vumc.com/
"ROR"	https://ror.org/00q6h8f30

Funders

Funder type

Hospital/treatment centre

Time of the researchers is paid by the institution VU University Medical Center (VUmc) (Netherlands).

No information available

As it is an observational study of usual care the direct costs are reimbursed by the insurance company.