Ectopic PregnancyNCT03253588
Laparoscopic Tubal Preservation Surgery
An observational study of Ectopic Pregnancy, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ectopic Pregnancy
- What is being tested?
- laparoscopic salpingotomy or salpingostomy
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 21 Feb 2017to 15 Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: women diagnosed with ectopic pregnancies and underwent laparoscopic tubal preservation surgery (including salpingostomy and salpingotomy)
Who may be able to join
- women who had laparoscopic tubal preservation surgery (including salpingostomy and salpingotomy) for ectopic pregnancy between January 2009 and November 2016
Who cannot join
- women with ectopic pregnancy at sites other than fallopian tube (i.e. interstitial, ovary, abdomen)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Outcome of Laparoscopic Tubal Preservation Surgery for Ectopic Pregnancy
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.
- Conditions
- Ectopic Pregnancy
- Being tested
- laparoscopic salpingotomy or salpingostomy
- Medical subject headings
- Pregnancy, Ectopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic salpingotomy or salpingostomyProcedure or surgery
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: between January 2009 and November 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2017
- Study start21 Feb 2017
- Primary completion15 Sep 2017
- Study completion15 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ectopic PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stella Ting Wan Hua, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03253588
- Sponsor's protocol ID
- 106002-E
- Status last verified
- Jul 2019
- First submitted
- 15 Aug 2017
- Last updated
- 30 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcome of Laparoscopic Tubal Preservation Surgery for Ectopic Pregnancy
- ClinicalTrials.gov ID
- NCT03253588
- Acronym / sponsor ID
- 106002-E
- Conditions
- Ectopic Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 21 Feb 2017 (actual)
- Primary completion
- 15 Sep 2017 (actual)
- Study completion
- 15 Oct 2017 (actual)
- First posted
- 18 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- women diagnosed with ectopic pregnancies and underwent laparoscopic tubal preservation surgery (including salpingostomy and salpingotomy)
Key inclusion criteria (1 listed)
- women who had laparoscopic tubal preservation surgery (including salpingostomy and salpingotomy) for ectopic pregnancy between January 2009 and November 2016
Key exclusion criteria (1 listed)
- women with ectopic pregnancy at sites other than fallopian tube (i.e. interstitial, ovary, abdomen)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laparoscopic salpingotomy or salpingostomyA 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). | Procedure or surgery | – |
Primary outcome
peri- and post-operative parameters
Time frame: between January 2009 and November 2016
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)
1 secondary outcome
factors affecting the surgical success rate
Time frame: between January 2009 and November 2016
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ectopic Pregnancy, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
peri- and post-operative parameters (time frame: between January 2009 and November 2016). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2019.