Same Day Discharge After Laparoscopic Hysterectomy | NCT05373238

Studies
Same Day Discharge After Laparoscopic Hysterectomy

NCT05373238

Sponsor

Bezmialem Vakif University

Status

Completed

Last Update Posted

Oct 12, 2022Actual

Enrollment

194Actual

Phase

Not provided

Conditions

Surgery--Complications

Interventions

Early discharge

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 15, 2021Actual

Primary Completion Date

Apr 30, 2022Actual

Completion Date

Apr 30, 2022Actual

First Submitted Date

May 5, 2022

First Submission Date that Met QC Criteria

May 9, 2022

First Posted Date

May 13, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 7, 2022

Last Update Posted Date

Oct 12, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

194Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Early Discharge		< discharge before 24 hours	Procedure: Early discharge
Late Discharge		discharge after 24 hours	Procedure: Early discharge

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Early discharge	Procedure	Early discharge	Early Discharge Late Discharge

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Complication in 30 days	Number of patients with surgical complications, postoperative complications, wound complications	30 days

Secondary Outcomes

Measure	Description	Time Frame
Postop hb	Number of patients whose hemoglobin value declined beyond two parameters. (mg/dL)	30 day
Postop htc	Number of patients whose hematocrit value declined more than 5 percent (%)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients Scheduled For Hysterectomy

Exclusion Criteria:

Diagnosis of Malignancy
Those with intraoperative complication

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Female patients aged 35-80 scheduled for laparoscopic hysterectomy

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gurkan Kiran	Bezmialem Vakif University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bezmialem Vakif University		Istanbul			Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided