Surgery--ComplicationsNCT04383860
Sutures in Orbital Implants in Retinoblastoma Patients
A study testing 5-0 suture and 4-0 suture in people with Surgery--Complications and Retinoblastoma Bilateral, run by Sun Yat-sen University.
Trial summary
The purpose of this study is to evaluate different sutures for orbital implants in retinoblastoma patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Surgery--Complications, Retinoblastoma Bilateral
- What is being tested?
- 5-0 suture and 4-0 suture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 1 Jul 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- diagnosed as retinoblastoma
- enucleation and orbital implantation in the same surgery
Who cannot join
- death during follow-up
About this study
Official title: Choice of Sutures in Orbital Implants in Retinoblastoma Patients
The purpose of this study is to evaluate different sutures for orbital implants in retinoblastoma patients.
Read the detailed description
To evaluate the effectiveness and complications of 4-0 and 5-0 sutures for orbital implants in retinoblastoma patients.
- Conditions
- Surgery--Complications, Retinoblastoma Bilateral
- Being tested
- 5-0 suture, 4-0 suture
- Keywords
- Retinoblastoma, suture, complications
- Medical subject headings
- Retinoblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-0 sutureProcedure or surgery
Also called 5-0 suture administration
5-0 suture administration during surgery
4-0 sutureProcedure or surgery
Also called 4-0 suture administration
4-0 suture administration during surgery
| Study group | Role | What they receive |
|---|---|---|
| 5-0 suture | Experimental | 5-0 suture administration during surgery Receives: Procedure: 5-0 suture |
| 4-0 suture | Active comparator | 4-0 suture administration during surgery Receives: Procedure: 4-0 suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of participants with complications
complications, such as orbital implant exposure in the follow-up visit
Measured: 2 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 posted12 May 2020
- Study start1 Jan 2015
- Primary completion31 Dec 2017
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery--ComplicationsStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huijing Ye, Sun Yat-sen University
- Investigators
- Huijing Ye, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04383860
- Sponsor's protocol ID
- 202001
- Status last verified
- Jun 2021
- First submitted
- 7 May 2020
- Last updated
- 15 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Choice of Sutures in Orbital Implants in Retinoblastoma Patients
- ClinicalTrials.gov ID
- NCT04383860
- Acronym / sponsor ID
- 202001
- Conditions
- Surgery--Complications, Retinoblastoma Bilateral
- Keywords
- Retinoblastoma, suture, complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 12 May 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.
The purpose of this study is to evaluate different sutures for orbital implants in retinoblastoma patients.
Detailed description
To evaluate the effectiveness and complications of 4-0 and 5-0 sutures for orbital implants in retinoblastoma patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5-0 suture | Experimental | Procedure: 5-0 suture5-0 suture administration during surgery |
| 4-0 suture | Active comparator | Procedure: 4-0 suture4-0 suture administration during surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- diagnosed as retinoblastoma
- enucleation and orbital implantation in the same surgery
Key exclusion criteria (1 listed)
- death during follow-up
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 |
|---|---|---|
| 5-0 sutureAlso: 5-0 suture administration5-0 suture administration during surgery | Procedure or surgery | 5-0 suture |
| 4-0 sutureAlso: 4-0 suture administration4-0 suture administration during surgery | Procedure or surgery | 4-0 suture |
Primary outcome
Rate of participants with complications
Time frame: 2 year after surgery
complications, such as orbital implant exposure in the follow-up visit
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 15 Jun 2021.
- 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.
Huijing Ye principal investigator
Sun Yat-sen University
Questions about this trial
What is this clinical trial studying?
A study testing 5-0 suture and 4-0 suture in people with Surgery--Complications and Retinoblastoma Bilateral, run by Sun Yat-sen University.
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 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 15 Jun 2021. 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?
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?
Rate of participants with complications (time frame: 2 year after surgery). 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 15 Jun 2021; AzTrials last refreshed its copy on 26 Oct 2026.