Immersive Virtual Reality Fitness Games to Improve Recovery After Colorectal Surgery: A Randomized Single Blind Controlled Pilot Trial.

Introduction: Early mobilization after surgery is crucial for reducing postoperative complications and restoring patients' fitness and ability to care for themselves. Immersive, activity-promoting fitness games in virtual reality (VR) can be used as a low-cost motivational adjunct to standard physiotherapy to promote recovery after surgery. In addition, they have potentially positive effects on mood and well-being, which are often compromised after colorectal surgery. The purpose of this pilot study was to evaluate the feasibility and clinical outcomes of a VR-based intervention that provides additional mobilization. Methods: Patients undergoing curative surgery for colorectal cancer were randomly assigned to an intervention group or a control group. Participants in the intervention group (VR group) received daily bedside fitness exercises using immersive, activity-promoting, virtual reality fitness games in addition to standard care during their postoperative hospital stay. Results: A total of 62 patients were randomized. The feasibility outcomes were in line with the predefined goals. In the VR group, an improvement in overall mood (+0.76 points; 95% confidence interval [CI] 0.39 to 1.12; P < 0.001) and a shift toward positive feelings were observed. The median length of hospital stay was 7.0 days in the VR group compared with 9.0 days in the control group, but the difference (2.0 days) did not reach statistical significance (95% CI -0.0001 to 3.00; P = 0.076). Surgical outcomes, health status, and measures of distress did not differ between groups. Conclusions: The study demonstrated the feasibility of a VR intervention that improved overall mood and showed a desirable effect on feelings and length of hospital stay after colorectal surgery. The results should stimulate further research investigating the potential of VR as an adjunct to physiotherapy to enhance mobilization after surgery.

Immersive virtual reality fitness games for enhancement of recovery after colorectal surgery: study protocol for a randomised pilot trial.

BACKGROUND: Physical inactivity after surgery is an important risk factor for postoperative complications. Compared to conventional physiotherapy, activity-promoting video games are often more motivating and engaging for patients with physical impairments. This effect could be enhanced by immersive virtual reality (VR) applications that visually, aurally and haptically simulate a virtual environment and provide a more interactive experience. The use of VR-based fitness games in the early postoperative phase could contribute to improved mobilisation and have beneficial psychological effects. Currently, there is no data on the use of VR-based fitness games in the early postoperative period after colorectal surgery. METHODS: This pilot trial features a single-centre, randomised, two-arm study design with a 1:1 allocation. Patients undergoing elective abdominal surgery for colorectal cancer or liver metastases of colorectal cancer will be recruited. Participants will be randomly assigned to an intervention group or a control group. Patients randomised to the intervention group will perform immersive virtual reality-based fitness exercises during their postoperative hospital stay. Feasibility and clinical outcomes will be assessed. DISCUSSION: Early mobilisation after surgery is crucial for reducing many postoperative complications. VR-based interventions are easy to use and often inexpensive, especially compared to interventions that require more medical staff and equipment. VR-based interventions could serve as an alternative or complement to regular physiotherapy and enhance mobilisation after surgery. The proposed pilot study will be the first step to evaluate the feasibility of VR-based interventions in the perioperative period, with the aim of improving the postoperative rehabilitation of cancer patients. TRIAL REGISTRATION: The trial has been registered in the German Clinical Trials Register (DRKS) Nr. DRKS00024888 , on April 13, 2021, WHO Universal Trial Number (UTN) U1111-1261-5968.

A randomised pilot trial of virtual reality-based relaxation for enhancement of perioperative well-being, mood and quality of life.

A cancer diagnosis and subsequent treatment can trigger distress, negatively impact coping resources, and affect well-being as well as quality of life. The aim of this pilot study was to investigate feasibility and clinical effects of a VR intervention on quality of life, well-being and mood in cancer patients undergoing surgery compared to a non-VR intervention and a control group. 54 patients with colorectal cancer or liver metastases from colorectal cancer undergoing elective curatively intended surgery were recruited and randomised to one of two intervention groups or a control group receiving standard treatment. Participants assigned to one of the intervention groups either received a VR-based intervention twice daily or listened to music twice daily. Adherence to the intervention was 64.6% in the music group and 81.6% in the VR group. The VR intervention significantly reduced heart rate (- 1.2 bpm; 95% CI - 2.24 to - 0.22; p = 0.02) and respiratory rate (- 0.7 brpm; 95% CI - 1.08 to - 0.25; p = 0.01). Self-reported overall mood improved in both groups (VR: + 0.79 pts; 95% CI 0.37-1.21; p = 0.001; music: + 0.59 pts; 95% CI 0.22-0.97; p = 0.004). There was no difference in quality of life between the three groups. Both interventions groups reported changes in feelings. Adherence rates favoured the VR intervention over the music group. Observed clinical outcomes showed stronger intragroup effects on mood, feelings, and vital signs in the VR group. The study demonstrated feasibility of a VR intervention in cancer patients undergoing surgery and should encourage further research investigating the potential of VR interventions to positively influence well-being and mood in cancer patients.

Intraoperative endoluminal pyloromyotomy for reduction of delayed gastric emptying after pylorus preserving partial pancreaticoduodenectomy (PORRIDGE trial): study protocol for a randomised controlled trial.

BACKGROUND: Pylorus-preserving pancreaticoduodenectomy (ppPD) is a standard surgical procedure for the treatment of resectable neoplasms of the periampullary region. One of the most common postoperative complications after ppPD is delayed gastric emptying (DGE) which reduces quality of life, prevents a timely return to a solid oral diet and prolongs the length of hospital stay. In a retrospective analysis, intraoperative endoluminal pyloromyotomy was associated with a reduced rate of DGE. The aim of this study is to investigate the effect of intraoperative endoluminal pyloromyotomy on postoperative DGE after ppPD in a randomised and controlled setting. METHODS: This randomised trial features parallel group design with a 1:1 allocation ratio and a superiority hypothesis. Patients with a minimum age of 18 years and an indication for ppPD are eligible to participate in this study and will be randomised intraoperatively to receive either endoluminal pyloromyotomy or atraumatic stretching of the pylorus. The sample size calculation (n=64 per study arm) is based on retrospective data. The primary endpoint is the rate of DGE within 30 days. Secondary endpoints are quality of life, operation time, estimated blood loss, length of hospital stay, morbidity and mortality. DISCUSSION: DGE after ppPD is a common complication with an incomplete understood aetiology. Prevention of DGE could improve outcomes and enhance quality of life after one of the most common procedures in pancreatic surgery. This trial will expand the existing evidence on intraoperative pyloromyotomy, and the results will provide additional data on a simple surgical technique that could reduce the incidence of postoperative DGE. TRIAL REGISTRATION: German Clinical Trials Register DRKS00013503 . Registered on 27 December 2017.

Intraoperative endoluminal pyloromyotomy as a novel approach to reduce delayed gastric emptying after pylorus-preserving pancreaticoduodenectomy-a retrospective study.

BACKGROUND: Delayed gastric emptying (DGE) is one of the most common complications after pylorus-preserving partial pancreaticoduodenectomy (ppPD). The aim of this retrospective study was to assess whether an intraoperative pyloromyotomy during ppPD prior to the creation of duodenojejunostomy reduces DGE. METHODS: Patients who underwent pylorus-preserving pancreaticoduodenectomy between January 2015 and December 2017 were divided into two groups on the basis of whether an intraoperative pyloromyotomy was performed (pyloromyotomy (PM) group) or not (no pyloromyotomy (NP) group). The primary endpoint was DGE according to the ISGPS definition. The confirmatory analysis of the primary endpoint was performed with multivariate analysis. RESULTS: One hundred and ten patients were included in the statistical analysis. Pyloromyotomy was performed in 44 of 110 (40%) cases. DGE of any grade was present in 62 patients (56.4%). The DGE rate was lower in the PM group (40.9%) compared with the NP group (66.7%), and pyloromyotomy was associated with a reduced risk for DGE in univariate (OR 0.35, 95% CI 0.16-0.76; P = 0.008) and multivariate analyses (OR 0.32, 95% CI 0.13-0.77; P = 0.011). The presence of an intra-abdominal complication was an independent risk factor for DGE in the multivariate analysis (OR 5.54, 95% CI 2.00-15.36; P = 0.001). CONCLUSION: Intraoperative endoluminal pyloromyotomy during ppPD was associated with a reduced risk for DGE in this retrospective study. Pyloromyotomy should be considered a simple technique that can potentially reduce DGE rates after ppPD.