NCT06278753

Brief Summary

For the evaluation of the lower urinary tract after laparoscopic hysterectomy, routine standard saline cystoscopy and carbon dioxide cystoscopy will be compared.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
540

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 26, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

February 12, 2025

Status Verified

February 1, 2025

Enrollment Period

2.5 years

First QC Date

January 4, 2022

Last Update Submit

February 8, 2025

Conditions

Bladder InjuryUreter InjurySurgical InjuryComplication of Surgical Procedure

Keywords

laparoscopic hysterectomylower urinary tract injurycystoscopy

Outcome Measures

Primary Outcomes (1)

  • It was aimed to evaluate the effectiveness and reliability of carbon dioxide cystoscopy.

    one year

Secondary Outcomes (1)

  • It was aimed to evaluate the speed and image quality of carbon dioxide cystoscopy in detecting intravesical masses.

    one year

Study Arms (2)

Standard cystoscopy

Standard cystoscopy arm

carbon dioxide cystoscopy

carbon dioxide cystoscopy arm

Diagnostic Test: carbon dioxide cystoscopy

Interventions

carbon dioxide cystoscopyDIAGNOSTIC_TEST

Using carbon dioxide medium for filling bladder

carbon dioxide cystoscopy

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailscystoscopy after laparoscopic hysterectomy
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who will undergo laparoscopic hysterectomy for benign reasons in our hospital

You may qualify if:

  • laparoscopic hysterectomy for benign reasons planned patients
  • The operation will be performed in our hospital
  • Reporting preoperative endometrial and cervical samplings as benign
  • After discharge, control examinations will be carried out in our hospital.

You may not qualify if:

  • Abdominal, robotic or vaginal hysterectomies
  • malignant reporting of preoperative cervical and endometrial samplings
  • Patients do not want to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tepecik Training and Research Hospital

Izmir, Eurasia, 35090, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Intraoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 4, 2022

First Posted

February 26, 2024

Study Start

July 1, 2021

Primary Completion

January 1, 2024

Study Completion

April 1, 2024

Last Updated

February 12, 2025

Record last verified: 2025-02

Locations

TU(1)