NCT03809468

Brief Summary

Patients will be randomized to clinic or telephone follow up after outpatient TLH. surveys will document patient satisfaction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

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

First Submitted

Initial submission to the registry

January 16, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

January 16, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 18, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

October 29, 2020

Status Verified

October 1, 2020

Enrollment Period

1.5 years

First QC Date

January 16, 2019

Last Update Submit

October 28, 2020

Conditions

Abnormal Uterine Bleeding

Keywords

patient satisfaction, hysterectomy, follow up

Outcome Measures

Primary Outcomes (1)

  • patient satisfaction

    patient satisfaction scores

    6-8 weeks postop

Secondary Outcomes (1)

  • phone calls and visits (unplanned)

    6-8 weeks postop

Study Arms (2)

control

NO INTERVENTION

Routine follow up of a clinic visit at 1-2 weeks postop, and 6-8 weeks postop.

study

EXPERIMENTAL

phone call follow up instead of clinic visit follow up at 1-2 weeks, followed by 6-8 week clinic follow up

Other: phone call follow up

Interventions

phone call follow upOTHER

instead of a clinic visit, patients will be randomized to a phone call

study

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • women undergoing minimally invasive hysterectomy

You may not qualify if:

  • patients without adequate phone or transportation access
  • patients with concern for underlying malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

MeSH Terms

Conditions

MetrorrhagiaPatient Satisfaction

Condition Hierarchy (Ancestors)

Uterine HemorrhageUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Pamela Frazzini Padilla

    Cleveland Clinic Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2019

First Posted

January 18, 2019

Study Start

January 16, 2019

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

October 29, 2020

Record last verified: 2020-10

Locations

US(1)