Contact information
Type
Scientific
Primary contact
Mrs P J Hajenius
ORCID ID
Contact details
Department of Obstetrics and Gynaecology
Academic Medical Center
University of Amsterdam
P.O. Box 22700
Amsterdam
1100 DE
Netherlands
+31 (0)20 5663654
esep@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0116151801
Study information
Scientific title
Randomised controlled trial of salpingostomy versus salpingectomy for tubal pregnancy, the impact of future fertility
Acronym
ESEP study - European Surgery in Ectopic Pregnancy
Study hypothesis
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
Ethics approval received from the local medical ethics committee
Study design
Randomised active-controlled parallel-group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Tubal pregnancy
Intervention
Salpingostomy versus salpingectomy.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/10/2004
Overall trial end date
01/01/2010
Reason abandoned
Eligibility
Participant inclusion criteria
Women with tubal pregnancy and a healthy contra-lateral tube.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
450
Participant 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
Recruitment start date
01/10/2004
Recruitment end date
01/01/2010
Locations
Countries of recruitment
Netherlands, Sweden, United Kingdom
Trial participating centre
Academic Medical Center
Amsterdam
1100 DE
Netherlands
Sponsor information
Organisation
European Surgery in Ectopic Pregnancy Study Group
Sponsor details
PO Box 22700
Academic Medical Center
University of Amsterdam
Amsterdam
1100 DE
Netherlands
+31 (0)20 5663654
esep@amc.uva.nl
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
King's College Hospital NHS Trust R&D Consortium (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D support funding (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Netherlands Organisation for Health Research and Development
Alternative name(s)
Netherlands Organisation for Health Research and Development
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
Netherlands
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
2008 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/18582372
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24499812
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26173606
Publication citations
-
Protocol
Mol F, Strandell A, Jurkovic D, Yalcinkaya T, Verhoeve HR, Koks CA, van der Linden PJ, Graziosi GC, Thurkow AL, Hoek A, Hogström L, Klinte I, Nilsson K, van Mello NM, Ankum WM, van der Veen F, Mol BW, Hajenius PJ, , The ESEP study: salpingostomy versus salpingectomy for tubal ectopic pregnancy; the impact on future fertility: a randomised controlled trial., BMC Womens Health, 2008, 8, 11, doi: 10.1186/1472-6874-8-11.
-
Results
Mol F, van Mello NM, Strandell A, Strandell K, Jurkovic D, Ross J, Barnhart KT, Yalcinkaya TM, Verhoeve HR, Graziosi GC, Koks CA, Klinte I, Hogström L, Janssen IC, Kragt H, Hoek A, Trimbos-Kemper TC, Broekmans FJ, Willemsen WN, Ankum WM, Mol BW, van Wely M, van der Veen F, Hajenius PJ, , Salpingotomy versus salpingectomy in women with tubal pregnancy (ESEP study): an open-label, multicentre, randomised controlled trial., Lancet, 2014, 383, 9927, 1483-1489, doi: 10.1016/S0140-6736(14)60123-9.
-
Results
Mol F, van Mello NM, Strandell A, Jurkovic D, Ross JA, Yalcinkaya TM, Barnhart KT, Verhoeve HR, Graziosi GC, Koks CA, Mol BW, Ankum WM, van der Veen F, Hajenius PJ, van Wely M; European Surgery in Ectopic Pregnancy (ESEP) study group; European Surgery in Ectopic Pregnancy ESEP study group, Cost-effectiveness of salpingotomy and salpingectomy in women with tubal pregnancy (a randomized controlled trial), Hum Reprod, 2015 , doi: 10.1093/humrep/dev162.