LaparoscopeNCT06047730
Clinical Effect Evaluation of Laparoscopic Surgery for Ovarian Benign Tumors by Different Approaches
An observational study of Laparoscope and Malignant Ovarian Tumor, run by Yingchun Ma at 1 site in China.
Trial summary
Main purpose: To compare the intraoperative and postoperative recovery of laparoscopic surgery for ovarian benign tumors through different approaches; Secondary objective: Will vNOTES increase the risk of cesarean section during pregnancy and affect the quality of sexual life after surgery. Read more about this study
- Who is it for?
- Ages 10 to 80 years, women only
- Conditions the study is for
- Laparoscope, Malignant Ovarian Tumor, Single-site Surgery
- What is being tested?
- operation ways
- Type of treatment
- Surgery or procedure
- How many people
- 173 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 31 Mar 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 10 to 80 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: nothing
Who may be able to join
- Preoperative consideration was for benign ovarian tumors requiring surgical treatment.
Who cannot join
- (1) Ovarian malignant tumor or borderline tumor was considered before surgery or proved during surgery. (2) Severe endometriosis, previous severe pelvic inflammation, peritonitis, and other serious pelvic adhesions are considered. (3) Pregnancy status. (4) Postoperative follow-up is not convenient and lost visitors.
Trial locations and contacts
1 site in 1 country.
China1 site
Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University
Jinan, Shandong
About this study
Main purpose: To compare the intraoperative and postoperative recovery of laparoscopic surgery for ovarian benign tumors through different approaches; Secondary objective: Will vNOTES increase the risk of cesarean section during pregnancy and affect the quality of sexual life after surgery.
- Conditions
- Laparoscope, Malignant Ovarian Tumor, Single-site Surgery
- Being tested
- operation ways
- Keywords
- Transumbilical laparoendoscopic single-site surgery,Giant malignant ovarian tumor
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
operation waysProcedure or surgery
nothing
| Study group | Role | What they receive |
|---|---|---|
| multi-port laparoscopic surgery | Not described Receives: Procedure: operation ways | |
| transumbilical laparoendoscopic single-site surgery | Not described Receives: Procedure: operation ways | |
| vaginal natural orifice transluminal endoscopic surgery | Not described Receives: Procedure: operation ways |
What is being measured
The primary outcome is the main question the study is designed to answer.
peroperative bleeding
peroperative bleeding
Measured: during the operation time
Secondary outcomes (1)
postoperative exhaust time
postoperative exhaust time
Measured: within 3 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Jan 2017
- Primary completion1 Jul 2022
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaparoscopeStudies 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 only
- Time perspective
- Retrospective
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yingchun Ma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yingchun Ma, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06047730
- Sponsor's protocol ID
- V50KFC
- Status last verified
- Sep 2023
- First submitted
- 14 Sep 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effect Evaluation of Laparoscopic Surgery for Ovarian Benign Tumors by Different Approaches
- ClinicalTrials.gov ID
- NCT06047730
- Acronym / sponsor ID
- V50KFC
- Conditions
- Laparoscope, Malignant Ovarian Tumor, Single-site Surgery
- Keywords
- Transumbilical laparoendoscopic single-site surgery,Giant malignant ovarian tumor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Yingchun MaUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 21 Sep 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.
Main purpose: To compare the intraoperative and postoperative recovery of laparoscopic surgery for ovarian benign tumors through different approaches; Secondary objective: Will vNOTES increase the risk of cesarean section during pregnancy and affect the quality of sexual life after surgery.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| multi-port laparoscopic surgery | – | Procedure: operation ways |
| transumbilical laparoendoscopic single-site surgery | – | Procedure: operation ways |
| vaginal natural orifice transluminal endoscopic surgery | – | Procedure: operation ways |
Who may qualify
- Ages
- 10 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- nothing
Key inclusion criteria (1 listed)
- Preoperative consideration was for benign ovarian tumors requiring surgical treatment.
Key exclusion criteria (1 listed)
- (1) Ovarian malignant tumor or borderline tumor was considered before surgery or proved during surgery. (2) Severe endometriosis, previous severe pelvic inflammation, peritonitis, and other serious pelvic adhesions are considered. (3) Pregnancy status. (4) Postoperative follow-up is not convenient and lost visitors.
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 |
|---|---|---|
| operation waysnothing | Procedure or surgery | multi-port laparoscopic surgery, transumbilical laparoendoscopic single-site surgery, vaginal natural orifice transluminal endoscopic surgery |
Primary outcome
peroperative bleeding
Time frame: during the operation time
peroperative bleeding
1 secondary outcome
postoperative exhaust time
Time frame: within 3 days after operation
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 21 Sep 2023.
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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 Laparoscope and Malignant Ovarian Tumor, run by Yingchun Ma 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 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 21 Sep 2023. 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?
peroperative bleeding (time frame: during the operation time). 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 21 Sep 2023.