NCT06307886

Brief Summary

Comparison of five-year survival and disease-free survival in patients diagnosed with endometrium cancer who underwent total laparoscopic hysterectomy with and without a uterine manipulator

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for all trials

Timeline
28mo left

Started Sep 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress54%
Sep 2023Sep 2028

Study Start

First participant enrolled

September 1, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 13, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Expected
Last Updated

January 7, 2025

Status Verified

December 1, 2024

Enrollment Period

2 years

First QC Date

March 6, 2024

Last Update Submit

January 4, 2025

Conditions

Endometrial Cancer

Outcome Measures

Primary Outcomes (2)

  • five year survival in patients diagnosed with endometrial cancer

    5 year

  • disease-free survival in patients diagnosed with endometrial cancer

    5 year

Study Arms (1)

patients diagnosed with endometrium cancer

Procedure: Patients Diagnosed With Endometrium Cancer Who Underwent Total Laparoscopic Hysterectomy With manipulatorProcedure: lPatients Diagnosed With Endometrium Cancer Who Underwent Total Laparoscopic Hysterectomy without uterine manipulator

Interventions

Patients Diagnosed With Endometrium Cancer Who Underwent Total Laparoscopic Hysterectomy With manipulatorPROCEDURE

patients who underwent laparoscopic hysterectomy with using uterine manipulator

patients diagnosed with endometrium cancer
lPatients Diagnosed With Endometrium Cancer Who Underwent Total Laparoscopic Hysterectomy without uterine manipulatorPROCEDURE

patients who underwent laparoscopic hysterectomy without using uterine manipulator

patients diagnosed with endometrium cancer

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients Diagnosed With Endometrium Cancer Who Underwent Total Laparoscopic Hysterectomy With and Without Uterine Manipulator

You may qualify if:

  • patients suitable for laparoscopic surgery patients ages 18-75 patients diagnosed figo stage 1 and 2 endometrial cancer

You may not qualify if:

  • patients not suitable for laparoscopic surgery patients diagnosed figo stage 3 and 4 endometrial cancer pregnant patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziosmanpasa Training and research hospital

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Central Study Contacts

Süleyman Salman, Professor

CONTACT

+905059345470sleymansalman@gmail.com

havva betül bacak, Specialist

CONTACT

+905333610088hbbacak90@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2024

First Posted

March 13, 2024

Study Start

September 1, 2023

Primary Completion

September 1, 2025

Study Completion (Estimated)

September 1, 2028

Last Updated

January 7, 2025

Record last verified: 2024-12

Locations

TU(1)