Comparative Study Between Conventional and Telematic Patients Follow-up

Study Overview
=================
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.

Official Title
-----------------
Comparative Study Between Conventional and Telematic Follow-up of Patient Treated in a General Ang GI Surgery Department (TLM-CGD)

Conditions
-----------------
Telemedicine, General Surgery, Outpatients

Intervention / Treatment
-----------------
* Other: Telematic follow-up


Participation Criteria
=================
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be included and assigned randomly, using an informatic program, to one of the study arms before hospital discharge.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Face-to-face follow-up<br>Face-to-face follow-up after hospital discharge | |
| Experimental: Telematic follow-up<br>Telematic follow-up after hospital discharge | Other: Telematic follow-up<br>* Telematic follow-up by using a platform with videoconference<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Follow-up accomplishment | Percentage of patients that can finish the follow-up in the assigned group | From date of discharge until the date of follow-up, 30 days after discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emergency department consultation | Comparison between number of emergency department consultations in each group if related to the surgical procedure | From discharge until 30 days after the follow-up date | 
| Patient satisfaction | Assessment of the patient satisfaction related to the follow-up using the NHS Outpatients Questionnaire. The results will be the comparision of percentage of each answer in each group. | 30 days after the follow-up date |