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.

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.

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.