Ectopic PregnancyNCT05890066
Single-port Versus Multi-port Laparoscopic Surgery for Ectopic Pregnancy
A study testing single-port laparoscopy in people with Ectopic Pregnancy, run by Hung Vuong Hospital.
Trial summary
This study aims to compare the effectiveness and Safety of Single-port Versus Multi-port Laparoscopic Surgery in the Treatment of Ectopic Pregnancy 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?
- single-port laparoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 31 May 2024
- 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
- 18 years old or older pregnant women who are indicated for laparoscopic surgery in the treatment of ectopic pregnancy.
- Agree to participate and give a consent
Who cannot join
- Allergic reactions to anesthetics
- Hemodynamic instability
- Ruptured ectopic pregnancy
Trial locations and contacts
No sites are listed yet.
NGOC T LAM, PhD contact
About this study
Official title: Effectiveness and Safety of Single-port Versus Multi-port Laparoscopic Surgery in the Treatment of Ectopic Pregnancy
This study aims to compare the effectiveness and Safety of Single-port Versus Multi-port Laparoscopic Surgery in the Treatment of Ectopic Pregnancy
Read the detailed description
Single-port laparoscopic surgery has become one of the treatment options for ectopic pregnancy with certain advantages such as reduced numbers of incision and scars, and increased patient's satisfaction post-surgery. At Hung Vuong hospital, the investigators do not have data about the application potential of single-port laparoscopic surgery for ectopic pregnancy treatment. Therefore, the investigators carry out this project to compare the effectiveness and safety of single-port versus traditional multi-port laparoscopic surgery in the treatment of ectopic pregnancy.
- Conditions
- Ectopic Pregnancy
- Being tested
- single-port laparoscopy
- Keywords
- Laparoscopic surgery, Single-port laparoscope, Multi-port laparoscope
- Medical subject headings
- Pregnancy, Ectopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single-port laparoscopyProcedure or surgery
Compare the effectiveness and safety between single-port and multi-port laparoscopic surgery
| Study group | Role | What they receive |
|---|---|---|
| 4-port laparoscopic surgery | No intervention | Patients with ectopic pregnancy will receive 4-Port laparoscopic surgery |
| 1-port laparoscopic surgery | Experimental | Patients with ectopic pregnancy will receive 1-port laparoscopic surgery Receives: Procedure: single-port laparoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood loss
Measure the amount of blood loss
Measured: Immediately post surgery
Surgical time
How long will it take for single-port vs multi-port surgical procedures
Measured: Immediately post surgery
Secondary outcomes (3)
Pain intensity
Use visual analogue scale to measure
Measured: Within 4 weeks post surgery
Surgical complications
Organ damages, surgical site infections, pneumoperitoneum
Measured: Within 4 weeks post surgery
Hospital stay
How long will be the recovery time
Measured: Within 4 weeks post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2023
- Study start1 Nov 2023 (estimated)
- Primary completion31 May 2024 (estimated)
- Study completion31 May 2024 (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.
- 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
- Model description
- The study is a parallel-group randomized control trial with 2 arms. Arm 1 includes patients who will be treated by traditional multi-port laparoscopic surgery. Aim 2 includes patients who will be treated by single-port laparoscopic surgery. All patients are randomized using computer-generated sequences with allocation ratio 1:1. This is a non-blinded study where all patients and surgical teams know the treatment option.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hung Vuong Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tri Bao Nguyen, Hung Vuong Hospital
- Investigators
- Nghiem X Huynh, Doctor, Study director, Hung Vuong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05890066
- Sponsor's protocol ID
- 5863
- Status last verified
- Jun 2023
- First submitted
- 25 May 2023
- Last updated
- 7 Jun 2023
- 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 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Single-port Versus Multi-port Laparoscopic Surgery in the Treatment of Ectopic Pregnancy
- ClinicalTrials.gov ID
- NCT05890066
- Acronym / sponsor ID
- 5863
- Conditions
- Ectopic Pregnancy
- Keywords
- Laparoscopic surgery, Single-port laparoscope, Multi-port laparoscope
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hung Vuong HospitalUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 6 Jun 2023 (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.
This study aims to compare the effectiveness and Safety of Single-port Versus Multi-port Laparoscopic Surgery in the Treatment of Ectopic Pregnancy
Detailed description
Single-port laparoscopic surgery has become one of the treatment options for ectopic pregnancy with certain advantages such as reduced numbers of incision and scars, and increased patient's satisfaction post-surgery. At Hung Vuong hospital, the investigators do not have data about the application potential of single-port laparoscopic surgery for ectopic pregnancy treatment. Therefore, the investigators carry out this project to compare the effectiveness and safety of single-port versus traditional multi-port laparoscopic surgery in the treatment of ectopic pregnancy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study is a parallel-group randomized control trial with 2 arms. Arm 1 includes patients who will be treated by traditional multi-port laparoscopic surgery. Aim 2 includes patients who will be treated by single-port laparoscopic surgery. All patients are randomized using computer-generated sequences with allocation ratio 1:1. This is a non-blinded study where all patients and surgical teams know the treatment option.
| Arm | Type | Receives |
|---|---|---|
| 4-port laparoscopic surgery | No intervention | –Patients with ectopic pregnancy will receive 4-Port laparoscopic surgery |
| 1-port laparoscopic surgery | Experimental | Procedure: single-port laparoscopyPatients with ectopic pregnancy will receive 1-port laparoscopic surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years old or older pregnant women who are indicated for laparoscopic surgery in the treatment of ectopic pregnancy.
- Agree to participate and give a consent
Key exclusion criteria (3 listed)
- Allergic reactions to anesthetics
- Hemodynamic instability
- Ruptured ectopic pregnancy
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 |
|---|---|---|
| single-port laparoscopyCompare the effectiveness and safety between single-port and multi-port laparoscopic surgery | Procedure or surgery | 1-port laparoscopic surgery |
Primary outcome
Blood loss
Time frame: Immediately post surgery
Measure the amount of blood loss
Surgical time
Time frame: Immediately post surgery
How long will it take for single-port vs multi-port surgical procedures
3 secondary outcomes
Pain intensity
Time frame: Within 4 weeks post surgery
Surgical complications
Time frame: Within 4 weeks post surgery
Hospital stay
Time frame: Within 4 weeks post surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
- 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.
NGOC T LAM, PhD contact
Nghiem X Huynh, Doctor study director
Hung Vuong Hospital
Questions about this trial
What is this clinical trial studying?
A study testing single-port laparoscopy in people with Ectopic Pregnancy, run by Hung Vuong Hospital.
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: status not confirmed, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Tri B Nguyen, Doctor (0983739959, ngoc.lam@ttu.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood loss (time frame: Immediately post surgery). 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 7 Jun 2023.