Telemedicine in postoperative follow‐up of STOMa PAtients: a randomized clinical trial (the STOMPA trial)

摘要

Background A stoma has severe impact on the patient's quality of life (QoL). Postoperative home community follow‐up by teleconsultation (TC) and stoma nurses may reduce the burden of travel and improve QoL. Methods A university hospital and five district medical centres participated. Patients with a stoma were randomized to follow‐up by either TC (intervention) or hospital (control). Stoma nurses performed the clinical examination at the TC studio, aided remotely by hospital nurses and surgeons. The primary endpoint was the EQ‐5D? index score; secondary endpoints were the Stoma Quality‐of‐Life Scale, the OutPatient Experiences Questionnaire, and use of hospital resources. Results A total of 110 patients were randomized to hospital (58 patients) or TC (52) follow‐up; 64 patients (hospital 38, TC 26) were followed for more than 12?months and 246 consultations (hospital 151, TC 95) were performed. There were no differences in QoL: EQ‐5D? index score ( P =?0·301) and EQ‐5D? visual analogue scale (VAS) score ( P =?0·775); Work/Social Function ( P =?0·822); Sexuality/Body Image ( P =?0·253) and Stoma Function ( P =?0·074). Hospital follow‐up performed better for organization of care (staff collaboration, P =?0·004; met same persons, P =?0·003) and communication (surgeon understandable, P ?0·001; surgeon caring P =?0·003). TC did not increase the number of hospital consultations ( P =?0·684) and reduced the number of journeys of more than 8?h ( P =?0·007). Conclusion Telemedicine follow‐up by stoma nurses did not improve the QoL of patients, but decreased the readmission rate and burden of travel. Registration number NCT01600508 ( https://www.clinicaltrials.gov ).