Clincosm LogoSign in Get a demo

Comparisons of Human Fibrin Glue (Tisseel) Versus Suture and Robotic Versus Traditional Laparoscopy for Ovarian Cystectomy

Sponsor
Far Eastern Memorial Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05946889
Collaborator
(none)
150
Enrollment
1
Location
1.7
Anticipated Duration (Months)
87.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Objective: To compare the effects of suture versus human fibrin glue during robotic or laparoscopic ovarian cystectomy

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Methods: The medical records of all consecutive women who received robotic or laparoscopic ovarian cystectomy between January 2016 and May 2022 were reviewed. Perioperative outcome and ovarian size were compared.

    Expected results: We can get the effects of suture versus human fibrin glue during robotic or laparoscopic ovarian cystectomy. The above information should be important for consultation.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    Comparisons of Human Fibrin Glue (Tisseel) Versus Suture and Robotic Versus Traditional Laparoscopy for Ovarian Cystectomy
    Anticipated Study Start Date :
    Jul 10, 2023
    Anticipated Primary Completion Date :
    Aug 31, 2023
    Anticipated Study Completion Date :
    Aug 31, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Suture

    Women with ovarian cyst who received robotic/laparoscopic ovarian cystectomy with suture
    Human Fibrin Glue

    Women with ovarian cyst who received robotic/laparoscopic ovarian cystectomy with human fibrin glue

    Outcome Measures

    Primary Outcome Measures

    1. Ovarian size [24 months]

      the ovarian size after ovarian cystectomy during follow-up

    Secondary Outcome Measures

    1. Blood loss [1 week]

      Estimated blood loss during perioperative period (including abdominal drainage)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    Female
    Inclusion Criteria:

    • 20 years old women

    • women who received robotic or laparoscopic ovarian cystectomy between January 2016 and May 2022 were reviewed.

    Exclusion Criteria:
    • Patients who underwent myomectomy at the same time.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital Banqiao New Taipei Taiwan 22050

    Sponsors and Collaborators

    • Far Eastern Memorial Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sheng-Mou Hsiao, Chief, Department of Obstetrics & Gynecology, Far Eastern Memorial Hospital
    ClinicalTrials.gov Identifier:
    NCT05946889
    Other Study ID Numbers:
    • 111192-E
    First Posted:
    Jul 14, 2023
    Last Update Posted:
    Jul 14, 2023
    Last Verified:
    Jul 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Ovarian Cysts

    Study Results

    No Results Posted as of Jul 14, 2023