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Sutures in Orbital Implants in Retinoblastoma Patients

Sponsor
Sun Yat-sen University (Other)
Overall Status
Completed
CT.gov ID
NCT04383860
Collaborator
(none)
132
Enrollment
2
Arms
66
Actual Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate different sutures for orbital implants in retinoblastoma patients.

Condition or Disease Intervention/Treatment Phase
  • Procedure: 5-0 suture
  • Procedure: 4-0 suture
 N/A

Detailed Description

To evaluate the effectiveness and complications of 4-0 and 5-0 sutures for orbital implants in retinoblastoma patients.

Study Design

Study Type:
Interventional
Actual Enrollment :
132 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Choice of Sutures in Orbital Implants in Retinoblastoma Patients
Actual Study Start Date :
Jan 1, 2015
Actual Primary Completion Date :
Dec 31, 2017
Actual Study Completion Date :
Jul 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: 5-0 suture

5-0 suture administration during surgery

Procedure: 5-0 suture
5-0 suture administration during surgery
Other Names:
  • 5-0 suture administration

    		•
    Active Comparator: 4-0 suture

    4-0 suture administration during surgery

    Procedure: 4-0 suture
    4-0 suture administration during surgery
    Other Names:
  • 4-0 suture administration

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Rate of participants with complications [2 year after surgery]

      complications, such as orbital implant exposure in the follow-up visit

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • diagnosed as retinoblastoma

    • enucleation and orbital implantation in the same surgery

    Exclusion Criteria:
    • death during follow-up

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Sun Yat-sen University

    Investigators

    • Principal Investigator: Huijing Ye, Sun Yat-sen University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Huijing Ye, Principal Investigator, Sun Yat-sen University
    ClinicalTrials.gov Identifier:
    NCT04383860
    Other Study ID Numbers:
    • 202001
    First Posted:
    May 12, 2020
    Last Update Posted:
    Jun 15, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Huijing Ye, Principal Investigator, Sun Yat-sen University
    Retinoblastoma
    suture
    complications
    Additional relevant MeSH terms:
    Retinoblastoma

    Study Results

    No Results Posted as of Jun 15, 2021