Salpingotomy versus salpingectomy in women with tubal pregnancy (ESEP study): An open-label, multicentre, randomised controlled trial

Femke Mol, Norah M. Van Mello, Annika Strandell, Karin Strandell, Davor Jurkovic, Jackie Ross, Kurt T. Barnhart, Tamer M. Yalcinkaya, Harold R. Verhoeve, Giuseppe C M Graziosi, Carolien A M Koks, Ingmar Klinte, Lars Hogström, Ineke C A H Janssen, Harry Kragt, Annemieke Hoek, Trudy C M Trimbos-Kemper, Frank J M Broekmans, Wim N P Willemsen, Willem M. Ankum & 4 others Ben W. Mol, Madelon Van Wely, Fulco Van Der Veen, Petra J. Hajenius

Research output: Contribution to journalArticle

63 Citations (Scopus)

Abstract

Background: Tubal ectopic pregnancy can be surgically treated by salpingectomy, in which the affected Fallopian tube is removed, or salpingotomy, in which the tube is preserved. Despite potentially increased risks of persistent trophoblast and repeat ectopic pregnancy, salpingotomy is often preferred over salpingectomy because the preservation of both tubes is assumed to offer favourable fertility prospects, although little evidence exists to support this assumption. We aimed to assess whether salpingotomy would improve rates of ongoing pregnancy by natural conception compared with salpingectomy. Methods: In this open-label, multicentre, international, randomised controlled trial, women aged 18 years and older with a laparoscopically confirmed tubal pregnancy and a healthy contralateral tube were randomly assigned via a central internet-based randomisation program to receive salpingotomy or salpingectomy. The primary outcome was ongoing pregnancy by natural conception. Differences in cumulative ongoing pregnancy rates were expressed as a fecundity rate ratio with 95% CI, calculated by Cox proportional-hazards analysis with a time horizon of 36 months. Secondary outcomes were persistent trophoblast and repeat ectopic pregnancy (expressed as relative risks [RRs] with 95% CIs) and ongoing pregnancy after ovulation induction, intrauterine insemination, or IVF. The researchers who collected data for fertility outcomes were masked to the assigned intervention, but patients and the investigators who analysed the data were not. All endpoints were analysed by intention to treat. We also did a (non-prespecified) meta-analysis that included the findings from the present trial. This trial is registered, number ISRCTN37002267. Findings: 446 women were randomly assigned between Sept 24, 2004, and Nov 29, 2011, with 215 allocated to salpingotomy and 231 to salpingectomy. Follow-up was discontinued on Feb 1, 2013. The cumulative ongoing pregnancy rate was 60.7% after salpingotomy and 56.2% after salpingectomy (fecundity rate ratio 1.06, 95% CI 0.81-1.38; log-rank p=0.678). Persistent trophoblast occurred more frequently in the salpingotomy group than in the salpingectomy group (14 [7%] vs 1 [<1%]; RR 15.0, 2.0-113.4). Repeat ectopic pregnancy occurred in 18 women (8%) in the salpingotomy group and 12 (5%) women in the salpingectomy group (RR 1.6, 0.8-3.3). The number of ongoing pregnancies after ovulation induction, intrauterine insemination, or IVF did not differ significantly between the groups. 43 (20%) women in the salpingotomy group were converted to salpingectomy during the initial surgery because of persistent tubal bleeding. Our meta-analysis, which included our own results and those of one other study, substantiated the results of the trial. Interpretation: In women with a tubal pregnancy and a healthy contralateral tube, salpingotomy does not significantly improve fertility prospects compared with salpingectomy.

LanguageEnglish
Pages1483-1489
Number of pages7
JournalThe Lancet
Volume383
Issue number9927
DOIs
Publication statusPublished - 1 Jan 2014

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Mol, F., Van Mello, N. M., Strandell, A., Strandell, K., Jurkovic, D., Ross, J., ... Hajenius, P. J. (2014). Salpingotomy versus salpingectomy in women with tubal pregnancy (ESEP study): An open-label, multicentre, randomised controlled trial. The Lancet, 383(9927), 1483-1489. https://doi.org/10.1016/S0140-6736(14)60123-9
Mol, Femke ; Van Mello, Norah M. ; Strandell, Annika ; Strandell, Karin ; Jurkovic, Davor ; Ross, Jackie ; Barnhart, Kurt T. ; Yalcinkaya, Tamer M. ; Verhoeve, Harold R. ; Graziosi, Giuseppe C M ; Koks, Carolien A M ; Klinte, Ingmar ; Hogström, Lars ; Janssen, Ineke C A H ; Kragt, Harry ; Hoek, Annemieke ; Trimbos-Kemper, Trudy C M ; Broekmans, Frank J M ; Willemsen, Wim N P ; Ankum, Willem M. ; Mol, Ben W. ; Van Wely, Madelon ; Van Der Veen, Fulco ; Hajenius, Petra J. / Salpingotomy versus salpingectomy in women with tubal pregnancy (ESEP study) : An open-label, multicentre, randomised controlled trial. In: The Lancet. 2014 ; Vol. 383, No. 9927. pp. 1483-1489.
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abstract = "Background: Tubal ectopic pregnancy can be surgically treated by salpingectomy, in which the affected Fallopian tube is removed, or salpingotomy, in which the tube is preserved. Despite potentially increased risks of persistent trophoblast and repeat ectopic pregnancy, salpingotomy is often preferred over salpingectomy because the preservation of both tubes is assumed to offer favourable fertility prospects, although little evidence exists to support this assumption. We aimed to assess whether salpingotomy would improve rates of ongoing pregnancy by natural conception compared with salpingectomy. Methods: In this open-label, multicentre, international, randomised controlled trial, women aged 18 years and older with a laparoscopically confirmed tubal pregnancy and a healthy contralateral tube were randomly assigned via a central internet-based randomisation program to receive salpingotomy or salpingectomy. The primary outcome was ongoing pregnancy by natural conception. Differences in cumulative ongoing pregnancy rates were expressed as a fecundity rate ratio with 95{\%} CI, calculated by Cox proportional-hazards analysis with a time horizon of 36 months. Secondary outcomes were persistent trophoblast and repeat ectopic pregnancy (expressed as relative risks [RRs] with 95{\%} CIs) and ongoing pregnancy after ovulation induction, intrauterine insemination, or IVF. The researchers who collected data for fertility outcomes were masked to the assigned intervention, but patients and the investigators who analysed the data were not. All endpoints were analysed by intention to treat. We also did a (non-prespecified) meta-analysis that included the findings from the present trial. This trial is registered, number ISRCTN37002267. Findings: 446 women were randomly assigned between Sept 24, 2004, and Nov 29, 2011, with 215 allocated to salpingotomy and 231 to salpingectomy. Follow-up was discontinued on Feb 1, 2013. The cumulative ongoing pregnancy rate was 60.7{\%} after salpingotomy and 56.2{\%} after salpingectomy (fecundity rate ratio 1.06, 95{\%} CI 0.81-1.38; log-rank p=0.678). Persistent trophoblast occurred more frequently in the salpingotomy group than in the salpingectomy group (14 [7{\%}] vs 1 [<1{\%}]; RR 15.0, 2.0-113.4). Repeat ectopic pregnancy occurred in 18 women (8{\%}) in the salpingotomy group and 12 (5{\%}) women in the salpingectomy group (RR 1.6, 0.8-3.3). The number of ongoing pregnancies after ovulation induction, intrauterine insemination, or IVF did not differ significantly between the groups. 43 (20{\%}) women in the salpingotomy group were converted to salpingectomy during the initial surgery because of persistent tubal bleeding. Our meta-analysis, which included our own results and those of one other study, substantiated the results of the trial. Interpretation: In women with a tubal pregnancy and a healthy contralateral tube, salpingotomy does not significantly improve fertility prospects compared with salpingectomy.",
author = "Femke Mol and {Van Mello}, {Norah M.} and Annika Strandell and Karin Strandell and Davor Jurkovic and Jackie Ross and Barnhart, {Kurt T.} and Yalcinkaya, {Tamer M.} and Verhoeve, {Harold R.} and Graziosi, {Giuseppe C M} and Koks, {Carolien A M} and Ingmar Klinte and Lars Hogstr{\"o}m and Janssen, {Ineke C A H} and Harry Kragt and Annemieke Hoek and Trimbos-Kemper, {Trudy C M} and Broekmans, {Frank J M} and Willemsen, {Wim N P} and Ankum, {Willem M.} and Mol, {Ben W.} and {Van Wely}, Madelon and {Van Der Veen}, Fulco and Hajenius, {Petra J.}",
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Mol, F, Van Mello, NM, Strandell, A, Strandell, K, Jurkovic, D, Ross, J, Barnhart, KT, Yalcinkaya, TM, Verhoeve, HR, Graziosi, GCM, Koks, CAM, Klinte, I, Hogström, L, Janssen, ICAH, Kragt, H, Hoek, A, Trimbos-Kemper, TCM, Broekmans, FJM, Willemsen, WNP, Ankum, WM, Mol, BW, Van Wely, M, Van Der Veen, F & Hajenius, PJ 2014, 'Salpingotomy versus salpingectomy in women with tubal pregnancy (ESEP study): An open-label, multicentre, randomised controlled trial', The Lancet, vol. 383, no. 9927, pp. 1483-1489. https://doi.org/10.1016/S0140-6736(14)60123-9

Salpingotomy versus salpingectomy in women with tubal pregnancy (ESEP study) : An open-label, multicentre, randomised controlled trial. / Mol, Femke; Van Mello, Norah M.; Strandell, Annika; Strandell, Karin; Jurkovic, Davor; Ross, Jackie; Barnhart, Kurt T.; Yalcinkaya, Tamer M.; Verhoeve, Harold R.; Graziosi, Giuseppe C M; Koks, Carolien A M; Klinte, Ingmar; Hogström, Lars; Janssen, Ineke C A H; Kragt, Harry; Hoek, Annemieke; Trimbos-Kemper, Trudy C M; Broekmans, Frank J M; Willemsen, Wim N P; Ankum, Willem M.; Mol, Ben W.; Van Wely, Madelon; Van Der Veen, Fulco; Hajenius, Petra J.

In: The Lancet, Vol. 383, No. 9927, 01.01.2014, p. 1483-1489.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Salpingotomy versus salpingectomy in women with tubal pregnancy (ESEP study)

T2 - Lancet

AU - Mol, Femke

AU - Van Mello, Norah M.

AU - Strandell, Annika

AU - Strandell, Karin

AU - Jurkovic, Davor

AU - Ross, Jackie

AU - Barnhart, Kurt T.

AU - Yalcinkaya, Tamer M.

AU - Verhoeve, Harold R.

AU - Graziosi, Giuseppe C M

AU - Koks, Carolien A M

AU - Klinte, Ingmar

AU - Hogström, Lars

AU - Janssen, Ineke C A H

AU - Kragt, Harry

AU - Hoek, Annemieke

AU - Trimbos-Kemper, Trudy C M

AU - Broekmans, Frank J M

AU - Willemsen, Wim N P

AU - Ankum, Willem M.

AU - Mol, Ben W.

AU - Van Wely, Madelon

AU - Van Der Veen, Fulco

AU - Hajenius, Petra J.

PY - 2014/1/1

Y1 - 2014/1/1

N2 - Background: Tubal ectopic pregnancy can be surgically treated by salpingectomy, in which the affected Fallopian tube is removed, or salpingotomy, in which the tube is preserved. Despite potentially increased risks of persistent trophoblast and repeat ectopic pregnancy, salpingotomy is often preferred over salpingectomy because the preservation of both tubes is assumed to offer favourable fertility prospects, although little evidence exists to support this assumption. We aimed to assess whether salpingotomy would improve rates of ongoing pregnancy by natural conception compared with salpingectomy. Methods: In this open-label, multicentre, international, randomised controlled trial, women aged 18 years and older with a laparoscopically confirmed tubal pregnancy and a healthy contralateral tube were randomly assigned via a central internet-based randomisation program to receive salpingotomy or salpingectomy. The primary outcome was ongoing pregnancy by natural conception. Differences in cumulative ongoing pregnancy rates were expressed as a fecundity rate ratio with 95% CI, calculated by Cox proportional-hazards analysis with a time horizon of 36 months. Secondary outcomes were persistent trophoblast and repeat ectopic pregnancy (expressed as relative risks [RRs] with 95% CIs) and ongoing pregnancy after ovulation induction, intrauterine insemination, or IVF. The researchers who collected data for fertility outcomes were masked to the assigned intervention, but patients and the investigators who analysed the data were not. All endpoints were analysed by intention to treat. We also did a (non-prespecified) meta-analysis that included the findings from the present trial. This trial is registered, number ISRCTN37002267. Findings: 446 women were randomly assigned between Sept 24, 2004, and Nov 29, 2011, with 215 allocated to salpingotomy and 231 to salpingectomy. Follow-up was discontinued on Feb 1, 2013. The cumulative ongoing pregnancy rate was 60.7% after salpingotomy and 56.2% after salpingectomy (fecundity rate ratio 1.06, 95% CI 0.81-1.38; log-rank p=0.678). Persistent trophoblast occurred more frequently in the salpingotomy group than in the salpingectomy group (14 [7%] vs 1 [<1%]; RR 15.0, 2.0-113.4). Repeat ectopic pregnancy occurred in 18 women (8%) in the salpingotomy group and 12 (5%) women in the salpingectomy group (RR 1.6, 0.8-3.3). The number of ongoing pregnancies after ovulation induction, intrauterine insemination, or IVF did not differ significantly between the groups. 43 (20%) women in the salpingotomy group were converted to salpingectomy during the initial surgery because of persistent tubal bleeding. Our meta-analysis, which included our own results and those of one other study, substantiated the results of the trial. Interpretation: In women with a tubal pregnancy and a healthy contralateral tube, salpingotomy does not significantly improve fertility prospects compared with salpingectomy.

AB - Background: Tubal ectopic pregnancy can be surgically treated by salpingectomy, in which the affected Fallopian tube is removed, or salpingotomy, in which the tube is preserved. Despite potentially increased risks of persistent trophoblast and repeat ectopic pregnancy, salpingotomy is often preferred over salpingectomy because the preservation of both tubes is assumed to offer favourable fertility prospects, although little evidence exists to support this assumption. We aimed to assess whether salpingotomy would improve rates of ongoing pregnancy by natural conception compared with salpingectomy. Methods: In this open-label, multicentre, international, randomised controlled trial, women aged 18 years and older with a laparoscopically confirmed tubal pregnancy and a healthy contralateral tube were randomly assigned via a central internet-based randomisation program to receive salpingotomy or salpingectomy. The primary outcome was ongoing pregnancy by natural conception. Differences in cumulative ongoing pregnancy rates were expressed as a fecundity rate ratio with 95% CI, calculated by Cox proportional-hazards analysis with a time horizon of 36 months. Secondary outcomes were persistent trophoblast and repeat ectopic pregnancy (expressed as relative risks [RRs] with 95% CIs) and ongoing pregnancy after ovulation induction, intrauterine insemination, or IVF. The researchers who collected data for fertility outcomes were masked to the assigned intervention, but patients and the investigators who analysed the data were not. All endpoints were analysed by intention to treat. We also did a (non-prespecified) meta-analysis that included the findings from the present trial. This trial is registered, number ISRCTN37002267. Findings: 446 women were randomly assigned between Sept 24, 2004, and Nov 29, 2011, with 215 allocated to salpingotomy and 231 to salpingectomy. Follow-up was discontinued on Feb 1, 2013. The cumulative ongoing pregnancy rate was 60.7% after salpingotomy and 56.2% after salpingectomy (fecundity rate ratio 1.06, 95% CI 0.81-1.38; log-rank p=0.678). Persistent trophoblast occurred more frequently in the salpingotomy group than in the salpingectomy group (14 [7%] vs 1 [<1%]; RR 15.0, 2.0-113.4). Repeat ectopic pregnancy occurred in 18 women (8%) in the salpingotomy group and 12 (5%) women in the salpingectomy group (RR 1.6, 0.8-3.3). The number of ongoing pregnancies after ovulation induction, intrauterine insemination, or IVF did not differ significantly between the groups. 43 (20%) women in the salpingotomy group were converted to salpingectomy during the initial surgery because of persistent tubal bleeding. Our meta-analysis, which included our own results and those of one other study, substantiated the results of the trial. Interpretation: In women with a tubal pregnancy and a healthy contralateral tube, salpingotomy does not significantly improve fertility prospects compared with salpingectomy.

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U2 - 10.1016/S0140-6736(14)60123-9

DO - 10.1016/S0140-6736(14)60123-9

M3 - Article

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SP - 1483

EP - 1489

JO - Lancet

JF - Lancet

SN - 0140-6736

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ER -