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Completed

NCT Number: NCT03304509

Comparative Study Between Conventional and Telematic Patients Follow-up

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.

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Key information

Conditions

Telemedicine General Surgery Outpatients

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telematic follow-up

Other

Telematic follow-up by using a platform with videoconference

Primary outcomes

  1. Follow-up accomplishment

    Time frame: From date of discharge until the date of follow-up, 30 days after discharge

    Percentage of patients that can finish the follow-up in the assigned group

Secondary outcomes

  1. Emergency department consultation

    Time frame: From discharge until 30 days after the follow-up date

    Comparison between number of emergency department consultations in each group if related to the surgical procedure

  2. Patient satisfaction

    Time frame: 30 days after the follow-up date

    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.

Sponsors and collaborators

Lead sponsor

Germans Trias i Pujol Hospital

Other

Registry information

Official study title

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

Acronym: TLM-CGD

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 9, 2017
Registry last updated
Aug 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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