Benign Ovarian TumorsNCT06201221
Single-port Laparoscopy in Children and Adolescents
An observational study of Benign Ovarian Tumors, run by Fujian Maternity and Child Health Hospital at 1 site in China.
Trial summary
To compare the safety evaluation, efficacy evaluation, long-term aesthetics and psychological satisfaction of single-port and multiport laparoscopy for children and adolescents with BOT in China. Read more about this study
- Who is it for?
- Ages 1 year to 18 years, women only
- Conditions the study is for
- Benign Ovarian Tumors
- What is being tested?
- single-port laparoscopy surgery and multiport laparoscopy surgery
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 1 Dec 2023
- 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 1 year to 18 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: All patients aged ≤18 years and pathologically diagnosed with BOT were collected from the electronic medical records of six gynecological oncology medical centers in Fujian, China between January 2019 and January 2023.
Who may be able to join
- Patients ≤18 years old
- Postoperative pathological diagnosis confirmed benign ovarian tumor
- Multi-hole laparoscopic or single-hole laparoscopic surgery
- Medical records and pathological data were complete and available
Who cannot join
- Patients with malignant pathological diagnosis
- Patients undergoing open surgery
- Incomplete medical records or pathological data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Advantages of Single-port Laparoscopy in the Treatment of Benign Ovarian Tumors in Children and Adolescents: A Multicenter Retrospective Study
To compare the safety evaluation, efficacy evaluation, long-term aesthetics and psychological satisfaction of single-port and multiport laparoscopy for children and adolescents with BOT in China.
- Conditions
- Benign Ovarian Tumors
- Being tested
- single-port laparoscopy surgery, multiport laparoscopy surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single-port laparoscopy surgeryProcedure or surgery
The two groups underwent different surgical procedures.
multiport laparoscopy surgeryProcedure or surgery
The two groups underwent different surgical procedures.
| Study group | Role | What they receive |
|---|---|---|
| Single-port Laparoscopy group | Single-port Laparoscopy in the Treatment of Benign Ovarian Tumors in Children and Adolescents Receives: Procedure: single-port laparoscopy surgery | |
| Multiport Laparoscopy group | Multiport Laparoscopy in the Treatment of Benign Ovarian Tumors in Children and Adolescents Receives: Procedure: multiport laparoscopy surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operation duration
The time elapsed from the initial incision to final skin closure
Measured: 3 hours
Secondary outcomes (2)
The Visual Analog Scale (VAS) score
Postoperative pain was evaluated by The Visual Analog Scale (VAS) score. The scale has a maximum score of 10 and a minimum score of 0, with higher scores meaning worse outcomes
Measured: 24 hours after surgery
5-point Likert scale
5-point Likert scale to assess the satisfaction at 1 month and 1 year post-operatively. The scale has a maximum score of 5 and a minimum score of 1, with higher scores meaning better outcomes
Measured: 1 month and 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start1 Jan 2019
- Primary completion1 Jan 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Ovarian TumorsStudies 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
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Maternity and Child Health Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Quanzhou First Hospital, First Affiliated Hospital of Fujian Medical University
- Responsible party
- Principal investigator, Yebin Feng, Fujian Maternity and Child Health Hospital
- Investigators
- Pengming Sun, Ph.D, Principal investigator, Fujian Maternity and Child Health Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06201221
- Sponsor's protocol ID
- FujianMCHH-Tong01
- Status last verified
- Dec 2023
- First submitted
- 9 Dec 2023
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- 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 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advantages of Single-port Laparoscopy in the Treatment of Benign Ovarian Tumors in Children and Adolescents: A Multicenter Retrospective Study
- ClinicalTrials.gov ID
- NCT06201221
- Acronym / sponsor ID
- FujianMCHH-Tong01
- Conditions
- Benign Ovarian Tumors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Fujian Maternity and Child Health HospitalUniversity, hospital or other
- Collaborators
- Quanzhou First Hospital, First Affiliated Hospital of Fujian Medical University
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 11 Jan 2024 (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.
To compare the safety evaluation, efficacy evaluation, long-term aesthetics and psychological satisfaction of single-port and multiport laparoscopy for children and adolescents with BOT in China.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-port Laparoscopy group | – | Procedure: single-port laparoscopy surgerySingle-port Laparoscopy in the Treatment of Benign Ovarian Tumors in Children and Adolescents |
| Multiport Laparoscopy group | – | Procedure: multiport laparoscopy surgeryMultiport Laparoscopy in the Treatment of Benign Ovarian Tumors in Children and Adolescents |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All patients aged ≤18 years and pathologically diagnosed with BOT were collected from the electronic medical records of six gynecological oncology medical centers in Fujian, China between January 2019 and January 2023.
Key inclusion criteria (4 listed)
- Patients ≤18 years old
- Postoperative pathological diagnosis confirmed benign ovarian tumor
- Multi-hole laparoscopic or single-hole laparoscopic surgery
- Medical records and pathological data were complete and available
Key exclusion criteria (3 listed)
- Patients with malignant pathological diagnosis
- Patients undergoing open surgery
- Incomplete medical records or pathological data
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 laparoscopy surgeryThe two groups underwent different surgical procedures. | Procedure or surgery | Single-port Laparoscopy group |
| multiport laparoscopy surgeryThe two groups underwent different surgical procedures. | Procedure or surgery | Multiport Laparoscopy group |
Primary outcome
Operation duration
Time frame: 3 hours
The time elapsed from the initial incision to final skin closure
2 secondary outcomes
The Visual Analog Scale (VAS) score
Time frame: 24 hours after surgery
5-point Likert scale
Time frame: 1 month and 1 year after surgery
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 11 Jan 2024.
- 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.
Pengming Sun, Ph.D principal investigator
Fujian Maternity and Child Health Hospital
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 Benign Ovarian Tumors, run by Fujian Maternity and Child Health Hospital at 1 site in China.
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 4 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 11 Jan 2024. 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 China. 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 duration (time frame: 3 hours). 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 11 Jan 2024.