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CompletedNCT03253588Updated Jul 30, 2019

Laparoscopic Tubal Preservation Surgery

An observational study in Ectopic Pregnancy, sponsored by Far Eastern Memorial Hospital. Completed at 1 site in Taiwan. Open to female participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-30.

Sponsored by Far Eastern Memorial Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
100
Ages
20 Years to 50 Years
Sex
Female
01

Study summary

Traditionally, salpingectomy has been the standard procedure for managing ectopic pregnancy. We would like to evaluate the safety and efficacy of laparoscopic tubal preservation surgery in treating ectopic pregnancies (salpingostomy or salpingotomy) while preserving the fertility outcome of the patients, as well as to identify the factors predicting the presence of persistent ectopic pregnancy after the surgery.

Read the detailed description

All surgically-treated ectopic pregnancies in women aged 20 and above between 01 January 2009 and 31 December 2016 were identified. Cases receiving laparoscopic salpingostomy or laparoscopic salpingotomy were extracted from the database, patient characteristics and surgical outcomes (changes of serumβ-hcg, presence of persistent ectopic pregnancy and subsequent management, subsequent pregnancy) were reviewed from their medical records. Univariate and multivariate logistic regression analysis were employed to predict the presence of persistent ectopic pregnancy after laparoscopic tubal preservation surgery.

02

Conditions studied

  • Ectopic Pregnancy

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03

In context

Pregnancy, Ectopic

83 studies on the registry are indexed under Pregnancy, Ectopic; 21 are open to participants now.

This study's enrollment of 100 is below the median of 150 across 39 observational studies indexed under Pregnancy, Ectopic.

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Lead sponsor

Far Eastern Memorial Hospital is the lead sponsor of 260 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

women diagnosed with ectopic pregnancies and underwent laparoscopic tubal preservation surgery (including salpingostomy and salpingotomy)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • women who had laparoscopic tubal preservation surgery (including salpingostomy and salpingotomy) for ectopic pregnancy between January 2009 and November 2016

Exclusion criteria

Exclusion Criteria:

  • women with ectopic pregnancy at sites other than fallopian tube (i.e. interstitial, ovary, abdomen)
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
100 participants (actual)
Patient registry
No

Interventions

  • Procedurelaparoscopic salpingotomy or salpingostomy

    A 3-port technique (2 x 5-mm and 1 x 10-mm trocars) was implemented. A diluted solution of vasopressin (20IU in 100 mL saline solution) was initially injected into the mesosalpinx of the affected tube, followed by a linear incision which allowed the removal of the gestational tissue. In case of a ruptured tubal pregnancy, the ectopic mass was evacuated directly from the ruptured site using a combination of forceps and suction device. The tubal lumen was either closed with a single-layer of continuous absorbable suture (salpingotomy) or left to heal by secondary intention (salpingostomy).

06

What researchers measure

Primary outcomes

  1. peri- and post-operative parameters

    success rate of tubal preservation surgery (defined by postoperative serum bcg \<5 IU/mL), postoperative complications (number of women who had adverse surgical outcome such as bladder injury, bowel injury, massive bleeding), pregnancy outcome (number of women who conceived successfully following the intervention)

    Time frame: between January 2009 and November 2016

Secondary outcomes

  1. factors affecting the surgical success rate

    relationship between patient's baseline characteristics and rate of persistent ectopic pregnancy (unvariate and multivariate analysis)

    Time frame: between January 2009 and November 2016

07

Study locations

1 site
  • Far Eastern Memorial Hospital
    Taipei, New Taipei City 220, Taiwan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2017 to primary completion in Sep 2017, 6 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 15, 2017
First posted
Aug 18, 2017
StartActual
Feb 21, 2017
Primary completionActual
Sep 15, 2017
CompletionActual
Oct 15, 2017
Last update
Jul 30, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03253588
Responsible party
Stella Ting Wan Hua (Principal Investigator, Far Eastern Memorial Hospital) — Principal investigator
First posted
Aug 18, 2017
Start date
Feb 21, 2017
Primary completion
Sep 15, 2017
Completion
Oct 15, 2017
Last update
Jul 30, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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