Ectopic PregnancyNCT03974841
Cornual Wedge Resection Outcome
An observational study of Ectopic Pregnancy and Laparoscopic, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Cornual pregnancy is a rare form of ectopic pregnancy that accounts for 2% to 4% of ectopic pregnancies, with a mortality rate between 2.0% and 2.5%. Traditionally, interstitial pregnancies were treated by laparotomy with cornial resection or hysterectomy. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Ectopic Pregnancy, Laparoscopic, Cornual Pregnancy
- What is being tested?
- laparoscopic cornual resection
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2016to 1 Jan 2019
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: postoperative results of patients who underwent laparoscopic cornual resection for cornual ectopic pregnancy, Patients forming the study group will be operated in the center for the last 3 years.
Who may be able to join
- cornual ectopic pregnancy
- Patients undergoing laparoscopic cornual wedge resection
Who cannot join
- medical treatment area due to cornual pregnancy
- laparotomy
- conservatively managed patients
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kanuni Sultan Süleyman Training and Research Hospital
Istanbul, 33404
About this study
Official title: Cornual Wedge Resection for Interstitial Pregnancy and Postoperative Outcome
Cornual pregnancy is a rare form of ectopic pregnancy that accounts for 2% to 4% of ectopic pregnancies, with a mortality rate between 2.0% and 2.5%. Traditionally, interstitial pregnancies were treated by laparotomy with cornial resection or hysterectomy. However, nowadays, increasingly interstitial pregnancies are treated by laparoscopic cranial resection.
Although this technique can potentially protect the fertility of the patient, it carries a serious risk of bleeding and requires a surgical experience.
- Conditions
- Ectopic Pregnancy, Laparoscopic, Cornual Pregnancy
- Being tested
- laparoscopic cornual resection
- Medical subject headings
- Pregnancy, Ectopic, Pregnancy, Cornual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic cornual resectionProcedure or surgery
patients undergoing laparoscopic cornual resection due to cornual ectopic pregnancy
What is being measured
The primary outcome is the main question the study is designed to answer.
Operation time
The duration of surgery of patients undergoing laparoscopic cornual resection due to cornual ectopic pregnancy
Measured: surgery from start to end
amount of bleeding
The amount of hemorrhage in patients undergoing laparoscopic cornual resection due to cornual ectopic pregnancy
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start1 Jan 2016
- Primary completion1 Jan 2019
- Study completion1 Jan 2019
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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pınar Kadirogulları, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03974841
- Sponsor's protocol ID
- 2019.06
- Status last verified
- Jun 2019
- First submitted
- 3 Jun 2019
- Last updated
- 5 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cornual Wedge Resection for Interstitial Pregnancy and Postoperative Outcome
- ClinicalTrials.gov ID
- NCT03974841
- Acronym / sponsor ID
- 2019.06
- Conditions
- Ectopic Pregnancy, Laparoscopic, Cornual Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 5 Jun 2019 (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.
Cornual pregnancy is a rare form of ectopic pregnancy that accounts for 2% to 4% of ectopic pregnancies, with a mortality rate between 2.0% and 2.5%. Traditionally, interstitial pregnancies were treated by laparotomy with cornial resection or hysterectomy. However, nowadays, increasingly interstitial pregnancies are treated by laparoscopic cranial resection.
Although this technique can potentially protect the fertility of the patient, it carries a serious risk of bleeding and requires a surgical experience.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- postoperative results of patients who underwent laparoscopic cornual resection for cornual ectopic pregnancy, Patients forming the study group will be operated in the center for the last 3 years.
Key inclusion criteria (2 listed)
- cornual ectopic pregnancy
- Patients undergoing laparoscopic cornual wedge resection
Key exclusion criteria (3 listed)
- medical treatment area due to cornual pregnancy
- laparotomy
- conservatively managed patients
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 cornual resectionpatients undergoing laparoscopic cornual resection due to cornual ectopic pregnancy | Procedure or surgery | – |
Primary outcome
Operation time
Time frame: surgery from start to end
The duration of surgery of patients undergoing laparoscopic cornual resection due to cornual ectopic pregnancy
amount of bleeding
Time frame: 48 hours
The amount of hemorrhage in patients undergoing laparoscopic cornual resection due to cornual ectopic pregnancy
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 5 Jun 2019.
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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 and Laparoscopic, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
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 2 inclusion and 3 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 5 Jun 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 Turkey (Türkiye). 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?
Operation time (time frame: surgery from start to end). The study lists 2 primary outcomes in all. 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 5 Jun 2019.