Condition category
Pregnancy and Childbirth
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
17/07/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.esepstudy.nl

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

http://www.amc.nl

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

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes