Condition category
Surgery
Date applied
23/04/2013
Date assigned
27/02/2014
Last edited
08/12/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Prof H.A.M. Brölmann

ORCID ID

Contact details

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

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 measures

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

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

http://www.vumc.com/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

08/12/2016: The overall trial end date has been updated from 12/12/2015 to 31/01/2018.