German Clinical Trials Register

Acronym/abbreviation of the study

MINT-ERAS

URL of the study

No Entry

Brief summary in lay language

The ERAS ("enhanced recovery after surgery") - pathway describes interprofessional management surrounding the surgery, which should make possible a fast recovery of the patient. ERAS includes patient-centered, evidence-based and procedure-specific treatment pathways designed to prevent organ malfunctions and prevent complications. Thus, after surgical intervention, physiological balance is rapidly restored postoperatively, which accelerates the entire recovery process of patients. The successful implementation of the ERAS treatment pathways has a reduced overall complication rate of up to half and a median two to three days shorter duration of inpatient stay compared to classic perioperative management in bowel operations. Early postoperative nutrition from the day of surgery, daily protein supplementation (600 kcal) to recompensate the postoperative catabolic phase and immediate, comprehensive mobilization after surgery (cumulatively six hours out of bed from post-op day 1) are essential success factors of the ERAS program. At the same time, the ERAS-goals in the areas food/protein intake and rapid, complete mobilization are big challenges to achieve, even in ERAS Centers of Excellence. Furthermore, ERAS-studys which investigate food intake and mobilization has so far largely recorded self-assessments of patients or nursing staff and no objective data. Last but not least, the goals set in the ERAS path are also predominantly general and not realistic for every patient; here a component of personalization and thus better motivation to achieve these goals is missing. Motivational interviewing is a well-known and evidence-based type of patient-centered conversation that was first described and developed by Miller and Rollnick in 1991. In the meantime, numerous studies have shown that motivational interviewing is an effective methodology suitable for everyday use in the context of family doctor and addiction medicine in the treatment of substance dependence, lifestyle and chronic diseases. Largely new and still little studied is the application in the context of complex abdominal surgery for optimal preparation and support of the postoperative recovery process. We hope to achieve a stronger implementation of the ERAS criteria in terms of postoperative exercise and nutrition through the motivational interviewing intervention. In addition, we see great potential in Motivational Interviewing as a basic attitude and ability of patient-centered and yet effective medicine, which should also be learnable and implementable in the dynamic inpatient everyday life of a university hospital. The aim of this randomized pilot study is to first examine whether these novel, patient-centered consultation and intervention can be implemented in an inpatient context for patients and the treatment team and whether they are accepted and positively evaluated by patients. By randomization, it will be examined exploratively whether patients who have participated in preoperative and postoperative intervention with motivational interviewing technique have significantly better achievement of the ERAS goals compared to the control group (patients whose conversations/visits take place without Motivational Interviewing elements). The focus is on a stronger achievement of early mobilization and sufficient nutrition, as defined as goals in the ERAS bowel-path in general and in the clinic-path of the Surgical Clinic: Mobilization from bed: 2h on the day of surgery, 6h from post-op day 1 to discharge; Nutrition: Protein supplementation of 600 kcal per day (e.g. 3x protein shakes with meals). Mobility is measured by three motion sensors (Garmin Vivosmart 4, Move 4 and ECG Move 4 of the company Movisens). The nutrition is tracked by photo documentation of the food ingested and the protein shakes. In addition, the objectively obtained data can also be used to draw conclusions as to whether the general target variables defined in the ERAS program are realistic for the vast majority of patients or whether individual target specifications should be individually adapted in order to be able to have a motivating effect.

Brief summary in scientific language

Perioperative management through ERAS ("enhanced recovery after surgery") means interprofessional, patient-centered work according to evidence-based, procedure-specific treatment pathways designed to prevent organ malfunctions and prevent complications. Thus, after surgical intervention, physiological homeostasis is rapidly restored postoperatively, which accelerates the entire recovery process of patients. The successful implementation of the ERAS treatment pathways has a reduced overall complication rate of up to half and a median two to three days shorter duration of inpatient stay compared to classic perioperative management in bowel operations. Early postoperative nutrition from the day of surgery, daily protein supplementation (600 kcal) to recompensate the postoperative catabolic phase and immediate, comprehensive mobilization after surgery (cumulatively six hours out of bed from post-op day 1) are essential success factors of the ERAS program. At the same time, the areas of food/protein intake and rapid, complete mobilization are the biggest challenges for achieving a high level of target compliance, even in ERAS Centers of Excellence. Furthermore, the ERAS compliance audit on food intake and mobilization scope has so far largely recorded self-assessments of patients or nursing staff and no objective data. Last but not least, the goals set in the ERAS path are also predominantly general and not realistic for every patient; here a component of personalization and thus better motivation to achieve these goals is missing. Motivational interviewing is a well-known and evidence-based type of patient-centered conversation that was first described and developed by Miller and Rollnick in 1991. In the meantime, numerous studies have shown that motivational interviewing is an effective methodology suitable for everyday use in the context of family doctor and addiction medicine in the treatment of substance dependence, lifestyle and chronic diseases. Largely new and still little studied is the application in the context of complex abdominal surgery for optimal preparation and support of the postoperative recovery process. We hope to achieve a stronger implementation of the ERAS criteria in terms of postoperative exercise and nutrition through the motivational interviewing intervention. In addition, we see great potential in MI as a basic attitude and ability of patient-centered and yet effective medicine, which should also be learnable and implementable in the dynamic inpatient everyday life of a university hospital. The MI-consultations in our study are carried out by two doctoral students with MI-Basic-Course certificate (+ Supervision and MITI evaluation by experienced MI coaches). The aim of this randomized pilot study is to first examine whether these novel, patient-centered consultation and intervention can be implemented in an inpatient context for patients and the treatment team and whether they are accepted and positively evaluated by patients. By randomization, it will be examined exploratively whether patients who have participated in preoperative and postoperative intervention with motivational interviewing technique have a significantly higher compliance with regard to the ERAS goals compared to the control group (patients whose conversations/visits take place without MI elements). The focus is on a stronger achievement of early mobilization and sufficient nutrition, as defined as goals in the ERAS bowel-path in general and in the clinic-path of the Surgical Clinic: Mobilization from bed: 2h on the day of surgery, 6h from post-op day 1 to discharge; Nutrition: Protein supplementation of 600 kcal per day (e.g. 3x protein shakes with meals). Mobility is measured by three motion sensors (Garmin Vivosmart 4, Move 4 and ECG Move 4 of the company Movisens). The nutrition is tracked by photo documentation of the food ingested and the protein shakes. In addition, the objectively obtained data can also be used to draw conclusions as to whether the general target variables defined in the ERAS program are realistic for the vast majority of patients or whether individual target specifications should be individually adapted in order to be able to have a motivating effect. Another goal of the pilot-study is to evaluate the novel study-design and generate first data to the endpoints. The findings of the pilot-study should be used to check the feasability and rationale of a multicentered follow-up study with an application for third-party funds.