Clinical trial NCT03304509: Comparative Study Between Conventional and Telematic Patients Follow-up
Official title: Comparative Study Between Conventional and Telematic Follow-up of Patient Treated in a General Ang GI Surgery Department (TLM-CGD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Telemedicine
General Surgery
Outpatients
Lead sponsor: Germans Trias i Pujol Hospital
Sponsor class: OTHER
First posted: 2017-10-09
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be included and assigned randomly, using an informatic program, to one of the study arms before hospital discharge.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a parallel group clinical trial comparing two types of follow-up in patients operated and treated in a General and GI surgery department. Face-to-face vs telematic follow-up by using a platform that offers videoconferencing will be compared.

Patients will be included and assigned randomly to each group using an informatics program until 100 patients are reached in each arm of the study ("n" total = 200 patients) The main and secondary outcomes will be evaluated 30 days after the date of the follow-up.

Detailed description: This is a parallel group clinical trial comparing two types of follow-up in patients operated and treated in a General and GI surgery department. Face-to-face vs telematic follow-up by using a platform that offers videoconferencing will be compared.

The hypothesis is that a follow-up based on a telematic visit will no add extra comorbidities while could reduce costs and increase patients satisfaction.

Patients will be included and assigned randomly to each group using an informatics program until 100 patients are reached in each arm of the study ("n" total = 200 patients) Information regarding the type of follow-up and the instructions to perform the telematic visit will be provided to patients before discharge. The follow-up date will be set according to the established protocol for each type of pathology.

In case of clinical complications patients will be referred to the emergency department or will be visited in face-to-face basis.

The main and secondary outcomes will be evaluated 30 days after the date of the follow-up.

Eligibility criteria: Inclusion Criteria:

* Patients treated or operated in the General and GI Surgery department in "Hospital Germans Trias i Pujol"

Exclusion Criteria:

* Proctological Surgery
* Personal conditions that not allow a correct comprehension or developement of the study
* Patients with postoperative complications greater than Clavien-Dindo grade II
* Not being in possession of the necessary informatic devices in case of telematic follow-up
* Not having a basic informatic knowledge in case of telematic follow-up

Primary outcomes:
measure: Follow-up accomplishment
timeFrame: From date of discharge until the date of follow-up, 30 days after discharge
Secondary outcomes:
measure: Emergency department consultation
timeFrame: From discharge until 30 days after the follow-up date
measure: Patient satisfaction
timeFrame: 30 days after the follow-up date
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Barcelona
Study officials:
affiliation: General and GI Surgical Department Staff
name: Manel Cremades, MD
role: PRINCIPAL_INVESTIGATOR
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