Influence of perioperative step volume on complication rate and length of hospital stay after colorectal cancer surgery (IPOS trial): study protocol for a randomised controlled single-centre trial at a German university hospital.

BACKGROUND: Perioperative mobilisation and physical activity are critical components of postoperative rehabilitation. Physical inactivity is a significant risk factor for complications and prolonged hospitalisation. However, specific recommendations for preoperative and postoperative physical activity levels are currently lacking. Evidence suggests that daily step count before and after surgery may impact the length of hospital stay and complication rate.The goal of this study is to determine the effectiveness of perioperative step volume recommendations, measured by pedometers, in reducing the length of hospital stay and complication rate for patients undergoing colorectal cancer surgery. METHODS: This study is a single-centre randomised controlled trial with two arms, allocated at a 1:1 ratio. The trial includes individuals undergoing colorectal surgery for either suspected or confirmed colorectal malignancy. A total of 222 patients will be randomly assigned to either an intervention or a control group. Step counts will be measured using a pedometer. Patients assigned to the intervention group will be given a predetermined preoperative and postoperative step count goal. The analysis will be conducted on preoperative and postoperative physical activity, quality of life, health, duration of hospitalisation, complication rate and bowel function, among other factors. ETHICS AND DISSEMINATION: The trial was approved by the ethics committee of the Ludwig-Maximilians-University of Munich, Germany (reference number: 22-0758, protocol version 2022.02). Results will be published in peer-reviewed journals and shared at academic conferences. After the publication of the results, a fully anonymised data set and the statistical code can be made available on justified scientific request and after ethical approval has been granted. TRIAL REGISTRATION NUMBER: DRKS00030017.

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.

Continuous and interrupted abdominal-wall closure after primary emergency midline laparotomy (CONIAC-trial): study protocol for a randomised controlled single centre trial.

INTRODUCTION: The optimal closure of the abdominal wall after emergency midline laparotomy is still a matter of debate due to lack of evidence. Although closure of the fascia using a continuous, all-layer suture technique with slowly absorbable monofilament material is common, complications like burst abdomen and hernia are frequent. METHODS AND ANALYSIS: This randomised controlled trial with a 1:1 allocation evaluates the efficacy and safety of a continuous suture with or without additional interrupted retention sutures for closure of the abdominal fascia. Patients with an indication for a primary emergency midline laparotomy are eligible to participate in this study and will be randomised intraoperatively via block randomisation. Fascia closure in the intervention group will be done with a standard continuous suture with slowly absorbable monofilament material (MonoMax 1, B. Braun, Tuttlingen, Germany) and additional interrupted retention sutures every 2 cm of the fascia using rapidly absorbable braided material (Vicryl 2, Ethicon, Norderstedt, Germany). In the control group, the fascia is closed only with the standard continuous suture with slowly absorbable monofilament material. Sample size calculations (n=111 per study arm) are based on the available literature. The primary endpoint is the rate of dehiscence of the abdominal fascia (rate of burst abdomen within 30 days or rate of incisional hernia within 12 months). Secondary endpoints are wound infections, quality of life, length of hospital stay, morbidity and mortality. Patients as well as individuals involved in data collection, endpoint assessment, data analysis and quality of life assessment will be blinded. ETHICS AND DISSEMINATION: The study protocol, the patient information and the informed consent form have been approved by the ethics committee of the Ludwig-Maximilians-University, Munich, Germany (reference number: 20-1041). Study findings will be submitted for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: DRKS00024802. WHO UNIVERSAL TRIAL NUMBER: U1111-1259-1956.

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.

Semiautomatic analysis of tumor proportion in colon cancer: Lessons from a validation study.

The tumor stroma ratio (TSR) is a promising histopathologic prognostic biomarker, which could allow for more accurate risk stratification and improved patient management in colorectal cancer. The purpose of our research was to validate the results of a previous study, which had suggested that not only a low but also a high tumor proportion (TP) might be an independent risk factor for occurrence of distant metastasis and worse overall survival using a semiautomatic image analysis approach with the open-source software ImageJ. We investigated 253 pT3 and pT4 adenocarcinomas of no special type. The previously established thresholds (PES-cut-offs) used to classify the patients (previous 3-tiered-classification) according to the tumor proportion (TP) in a highTP (TP ≥ 54%), a mediumTP (TP < 54% ∩ TP >15%) and a lowTP (TP ≤ 15%) group did not show a significant risk stratification. Even the adjustment of these threshold revealed no significant results. Therefore, a receiver-operating characteristic (ROC) analysis was performed to establish the cut-off with the most significant predictive power and a "new 2-tiered-classification" using this cut-off (40% at MinTP) showed a significantly shorter absence of metastasis for patients with a low TP (p = 0.007). These results confirm that a low TP is associated with an adverse prognosis. This study did not confirm the previous assumption that a high TP might also be a risk factor for occurrence of metastasis. Furthermore, it demonstrates that this semiautomatic technique is not superior to the established method, so that approaches to enhance prognostic techniques should continue.

Virtual reality-based relaxation for enhancement of perioperative well-being and quality of life: protocol for a randomised pilot trial.

INTRODUCTION: Patients with cancer undergoing surgery often suffer from reduced quality of life and various forms of distress. Untreated distress can negatively affect coping resources as well as surgical and oncological outcomes. A virtual reality-based stress reduction intervention may increase quality of life and well-being and reduce distress in the perioperative phase for patients with cancer. This pilot trial aims to explore the feasibility of the proposed intervention, assess patient acceptability and obtain estimates of effect to provide data for sample size calculations. METHODS AND ANALYSIS: Patients with colorectal cancer and liver metastasis undergoing elective surgery will be recruited for this single-centre, randomised pilot trial with a three-arm design. A total of 54 participants will be randomised at 1:1:1 ratio to one of two intervention groups or a control receiving standard treatment. Those randomised to an intervention group will either receive perioperative virtual reality-based stress reduction exercises twice daily or listen to classical music twice daily. Primary feasibility outcomes are number and proportions of participants recruited, screened, consented and randomised. Furthermore, adherence to the intervention, compliance with the completion of the quality of life questionnaires and feasibility of implementing the trial procedures will be assessed. Secondary clinical outcomes are measurements of the effectiveness of the interventions to inform sample size calculations. ETHICS AND DISSEMINATION: The study protocol, the patient information and the informed consent form have been approved by the ethics committee of the Ludwigs-Maximilians-University, Munich, Germany (Reference Number: 19-915). Study findings will be submitted for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: DRKS00020909.

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.