Comparative Study Between Conventional and Telematic Patients Follow-up (TLM-CGD)

Germans Trias i Pujol Hospital

Status: Completed

Conditions: General Surgery; Outpatients; Telemedicine

Treatments: Other: Telematic follow-up

Study type: Interventional

Funder types: Other

Identifiers

NCT03304509

GermansTIPH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

200 participants in 2 patient groups

Face-to-face follow-up

No Intervention group

Description:

Face-to-face follow-up after hospital discharge

Telematic follow-up

Experimental group

Description:

Telematic follow-up after hospital discharge

Treatment:

Other: Telematic follow-up