Randomised controlled trial of salpingostomy versus salpingectomy for tubal pregnancy, the impact of future fertility

ISRCTN	ISRCTN37002267
DOI	https://doi.org/10.1186/ISRCTN37002267
Secondary identifying numbers	N0116151801

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mrs P J Hajenius
Scientific

Department of Obstetrics and Gynaecology
Academic Medical Center
University of Amsterdam
P.O. Box 22700
Amsterdam
1100 DE
Netherlands

Phone	+31 (0)20 5663654
Email	esep@amc.uva.nl

Study design	Randomised active-controlled parallel-group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Randomised controlled trial of salpingostomy versus salpingectomy for tubal pregnancy, the impact of future fertility
Study acronym	ESEP study - European Surgery in Ectopic Pregnancy
Study objectives	Whether the potential advantage of salpingostomy (opening the fallopian tube to remove pregnancy) i.e. better fertility prognosis as compared to salpingectomy (removing the fallopian tube with the pregnancy), outweighs the potential disadvantages of this treatment i.e. persistent trophoblast and an increased risk for ectopic pregnancy.
Ethics approval(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	Tubal pregnancy
Intervention	Salpingostomy versus salpingectomy.
Intervention type	Other
Primary outcome measure	Time to occurrence of a spontaneous intra uterine pregnancy.
Secondary outcome measures	Persistent trophoblast and repeat ectopic pregnancy. A cost-effectiveness analysis will be performed.
Overall study start date	01/10/2004
Completion date	01/01/2010

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	450
Key inclusion criteria	Women with tubal pregnancy and a healthy contra-lateral tube.
Key exclusion criteria	1. Aged less than 18 years 2. Shock 3. Pregnant after In Vitro Fertilisation and Embryo Transfer (IVF-ET) 4. Known tubal pathology 5. No fertility wish
Date of first enrolment	01/10/2004
Date of final enrolment	01/01/2010

Academic Medical Center

Amsterdam
1100 DE
Netherlands

European Surgery in Ectopic Pregnancy Study Group
University/education

PO Box 22700
Academic Medical Center
University of Amsterdam
Amsterdam
1100 DE
Netherlands

Government

King's College Hospital NHS Trust R&D Consortium (UK)

No information available

NHS R&D support funding (UK)

No information available

Netherlands Organisation for Health Research and Development
Private sector organisation / Other non-profit organizations

Alternative name(s): Netherlands Organisation for Health Research and Development
Location: Netherlands

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

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Protocol article	protocol	26/06/2008	Yes	No
Results article	results	26/04/2014	Yes	No
Results article	results	01/09/2015	Yes	No