Ectopic PregnancyNCT04315779
Comparison of Two Different Approaches in the Surgical Treatment of Tubal Ectopic Pregnancy
A study testing Salpingectomy in people with Ectopic Pregnancy, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
In this study we aim to compare conventional laparoscopy and natural orifice transluminal endoscopic surgery in the surgical treatment of ectopic pregnancy. All the patients, with an indication of surgery for ectopic pregnancy, will be asked to participate in this clinical trial. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ectopic Pregnancy
- What is being tested?
- Salpingectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Feb 2020to 19 May 2021
- Phase
- Interventional
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults over 18 years of age,
- Diagnosis of tubal ectopic pregnancy
- Patient's preference to undergo salpingectomy
Who cannot join
- Patients with contraindication to endoscopic surgery
- Refusal to sign informed consent.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ege University University Hospital, Department of Obstetrics and Gynecology
Bornova, İzmir, 35100
Gokay Ozceltik, +905330922020, gokayozceltik@hotmail.com
About this study
Official title: Comparison of Conventional Laparoscopy and Natural Orifice Transluminal Endoscopic Surgery in the Surgical Treatment of Tubal Ectopic Pregnancy
In this study we aim to compare conventional laparoscopy and natural orifice transluminal endoscopic surgery in the surgical treatment of ectopic pregnancy.
All the patients, with an indication of surgery for ectopic pregnancy, will be asked to participate in this clinical trial.
Read more
Indication of surgery will be based on clinical findings, ultrasound scans and serum hcg levels. There will be no exclusion criteria.
Duration of surgery, successful completion of the operation, intraoperative data and postoperative data will be collected.
All the patients will be asked to fill out quality of recovery-40 (QoR-40) questionnaire and 36-item short form health survey (SF-36) before surgery.
QoR-40 questionnaire will be repeated 24 hours after surgery and repeated every 24 hours until discharge. SF-36 will be repeated at 1-month follow-up visit. Patients will be also evaluated at postoperative 3-months, and female sexual function index will be asked to be filled-out.
- Conditions
- Ectopic Pregnancy
- Being tested
- Salpingectomy
- Keywords
- natural orifice transluminal endoscopic surgery, laparoscopy, ectopic pregnancy, minimally invasive surgery, quality of life, sexual function
- Medical subject headings
- Pregnancy, Ectopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalpingectomyProcedure or surgery
Patients will undergo removal of the affected tube
| Study group | Role | What they receive |
|---|---|---|
| Conventional laparoscopy | Active comparator | In this arm, patients will be treated via conventional laparoscopy Receives: Procedure: Salpingectomy |
| Transvaginal natural orifice transluminal endoscopic surgery | Active comparator | In this arm, patients will be treated via transvaginal natural orifice transluminal endoscopic surgery Receives: Procedure: Salpingectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful completion of surgery as intended
The completion of the surgery with the route planned without having to change the surgical route
Measured: Intraoperative, from the beginning to the end of surgical intervention
Operating time
Measured: Intraoperative
Reoperation rate
Measured: During follow-up, after surgery until hcg level drops below 5 U/L, up to 1 month
Complication rate
Measured: During follow-up, after surgery until hcg level drops below 5 U/L, up to 1 month
Secondary outcomes (5)
Quality of Recovery-40 questionnaire
The Quality of Recovery 40 questionnaire will be self-administered by patients at different time points
Measured: Preoperatively and Postoperative every 24 hours until discharge, expected to be up to 3 days following surgery
Quality of life change
Short form 36 item health survery (SF-36) questionnaire will be self-administered by patients at different time points
Measured: Preoperative, Postoperative 1-month
Postoperative pain scores
Postoperative pain will be assessed on a 10-cm visual analog scale at different time points
Measured: Postoperative 2 hours, 6 hours, 12 hours, 24 hours, and every 24 hours until discharge (if the patient stays longer than 1 day at the hospital), , expected to be up to 3 days following surgery
Sexual function
Female sexual function index (FSFI) questionnaire will be self-administered by patients at postoperative 3-months
Measured: Postoperative 3 months
The need for additional analgesic use
Patients will be routinely administered pethidine hydrochloride 3x50 mg parenteral on the day of surgery. Starting from postoperative day 1 patients will be administered paracetamol 500 mg oral upon their request. In case of inadequate pain relief and the need for additional analgesic use will ve recorded.
Measured: Postoperative period until discharge, expected to be up to 3 days following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2020
- Study start19 Feb 2020
- Primary completion19 Feb 2021 (estimated)
- Study completion19 May 2021 (estimated)
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.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gokay Ozceltik, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04315779
- Sponsor's protocol ID
- 20-2.1T/40
- Status last verified
- Mar 2020
- First submitted
- 17 Mar 2020
- Last updated
- 20 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Conventional Laparoscopy and Natural Orifice Transluminal Endoscopic Surgery in the Surgical Treatment of Tubal Ectopic Pregnancy
- ClinicalTrials.gov ID
- NCT04315779
- Acronym / sponsor ID
- 20-2.1T/40
- Conditions
- Ectopic Pregnancy
- Keywords
- natural orifice transluminal endoscopic surgery, laparoscopy, ectopic pregnancy, minimally invasive surgery, quality of life, sexual function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 19 Feb 2020 (actual)
- Primary completion
- 19 Feb 2021 (estimated)
- Study completion
- 19 May 2021 (estimated)
- First posted
- 20 Mar 2020 (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.
In this study we aim to compare conventional laparoscopy and natural orifice transluminal endoscopic surgery in the surgical treatment of ectopic pregnancy.
All the patients, with an indication of surgery for ectopic pregnancy, will be asked to participate in this clinical trial.
Indication of surgery will be based on clinical findings, ultrasound scans and serum hcg levels. There will be no exclusion criteria.
Duration of surgery, successful completion of the operation, intraoperative data and postoperative data will be collected.
All the patients will be asked to fill out quality of recovery-40 (QoR-40) questionnaire and 36-item short form health survey (SF-36) before surgery.
QoR-40 questionnaire will be repeated 24 hours after surgery and repeated every 24 hours until discharge. SF-36 will be repeated at 1-month follow-up visit. Patients will be also evaluated at postoperative 3-months, and female sexual function index will be asked to be filled-out.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional laparoscopy | Active comparator | Procedure: SalpingectomyIn this arm, patients will be treated via conventional laparoscopy |
| Transvaginal natural orifice transluminal endoscopic surgery | Active comparator | Procedure: SalpingectomyIn this arm, patients will be treated via transvaginal natural orifice transluminal endoscopic surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults over 18 years of age,
- Diagnosis of tubal ectopic pregnancy
- Patient's preference to undergo salpingectomy
Key exclusion criteria (2 listed)
- Patients with contraindication to endoscopic surgery
- Refusal to sign informed consent.
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 |
|---|---|---|
| SalpingectomyPatients will undergo removal of the affected tube | Procedure or surgery | Conventional laparoscopy, Transvaginal natural orifice transluminal endoscopic surgery |
Primary outcome
Successful completion of surgery as intended
Time frame: Intraoperative, from the beginning to the end of surgical intervention
The completion of the surgery with the route planned without having to change the surgical route
Operating time
Time frame: Intraoperative
Reoperation rate
Time frame: During follow-up, after surgery until hcg level drops below 5 U/L, up to 1 month
Complication rate
Time frame: During follow-up, after surgery until hcg level drops below 5 U/L, up to 1 month
5 secondary outcomes
Quality of Recovery-40 questionnaire
Time frame: Preoperatively and Postoperative every 24 hours until discharge, expected to be up to 3 days following surgery
Quality of life change
Time frame: Preoperative, Postoperative 1-month
Postoperative pain scores
Time frame: Postoperative 2 hours, 6 hours, 12 hours, 24 hours, and every 24 hours until discharge (if the patient stays longer than 1 day at the hospital), , expected to be up to 3 days following surgery
Sexual function
Time frame: Postoperative 3 months
The need for additional analgesic use
Time frame: Postoperative period until discharge, expected to be up to 3 days following surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2020.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Salpingectomy in people with Ectopic Pregnancy, run by Ege University 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 20 Mar 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gokay Ozceltik (+905330922020, gokayozceltik@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful completion of surgery as intended (time frame: Intraoperative, from the beginning to the end of surgical intervention). The study lists 4 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 20 Mar 2020.