NCT05373238

Brief Summary

Patients who are scheduled for laparoscopic hysterectomy will be included in the study. After the operation, those who are well and without major distress will be discharged from the hospital before 24 hours. Those who have pain or have additional health problems will be observed further. Our aim is to compare these two groups in terms of early complications and operation characteristics.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
194

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 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

October 15, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 5, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 13, 2022

Completed
Last Updated

October 12, 2022

Status Verified

October 1, 2022

Enrollment Period

7 months

First QC Date

May 5, 2022

Last Update Submit

October 7, 2022

Conditions

Surgery--Complications

Outcome Measures

Primary Outcomes (1)

  • Complication in 30 days

    Number of patients with surgical complications, postoperative complications, wound complications

    30 days

Secondary Outcomes (2)

  • Postop hb

    30 day

  • Postop htc

    30 day

Study Arms (2)

Early Discharge

\< discharge before 24 hours

Procedure: Early discharge

Late Discharge

discharge after 24 hours

Procedure: Early discharge

Interventions

Early dischargePROCEDURE

Early discharge

Early DischargeLate Discharge

Eligibility Criteria

Age35 Years - 80 Years
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Female patients aged 35-80 scheduled for laparoscopic hysterectomy

You may qualify if:

  • Patients Scheduled For Hysterectomy

You may not qualify if:

  • Diagnosis of Malignancy
  • Those with intraoperative complication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif University

Istanbul, Turkey (Türkiye)

Location

Study Officials

  • Gurkan Kiran

    Bezmialem Vakif University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 5, 2022

First Posted

May 13, 2022

Study Start

October 15, 2021

Primary Completion

April 30, 2022

Study Completion

April 30, 2022

Last Updated

October 12, 2022

Record last verified: 2022-10

Locations

TU(1)