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

Abstract

Abstract 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).