Multicenter Prospective Cohort Study of the Patient-Reported Outcome Measures PRO-CTCAE and CAT EORTC QLQ-C30 in Major Abdominal Cancer Surgery (PATRONUS): A Student-Initiated German Medical Audit (SIGMA) Study

Abstract

Background The patient-reported outcomes (PRO) version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) and the computerized adaptive testing (CAT) version of the EORTC quality-of-life questionnaire QLQ-C30 have been proposed as new PRO measures in oncology; however, their implementation in patients undergoing cancer surgery has not yet been evaluated. Methods Patients undergoing elective abdominal cancer surgery were enrolled in a prospective multicenter study, and postoperative complications were recorded according to the Dindo–Clavien classification. Patients reported PRO data using the CAT EORTC QLQ-C30 and the PRO-CTCAE to measure 12 core cancer symptoms. Patients were followed-up for 6 months postoperatively. The study was carried out by medical students of the CHIR-Net SIGMA study network. Results Data of 303 patients were obtained and analyzed across 15 sites. PRO-CTCAE symptoms ‘poor appetite’, ‘fatigue’, ‘exhaustion’ and ‘sleeping problems’ increased after surgery and climaxed 10–30 days postoperatively. At 3–6 months postoperatively, no PRO-CTCAE symptom differed significantly to baseline. Patients reported higher ‘social functioning’ (p = 0.021) and overall quality-of-life scores (p < 0.05) 6 months after cancer surgery compared with the baseline level. There was a lack of correlation between postoperative complications or death and any of the PRO items evaluated. Feasibility endpoints for student-led research were met. Conclusion The two novel PRO questionnaires were successfully applied in surgical oncology. Postoperative complications do not affect health-reported quality-of-life or common cancer symptoms following major cancer surgery. The feasibility of student-led multicenter clinical research was demonstrated, but might be enhanced by improved student training.

Patient-Reported Outcomes Measures in Abdominal Cancer Surgery and Student-Led Surgical Research

“…In this issue of the Annals of Surgical Oncology, Mihaljevic and coauthors show the importance of patientreported outcomes measures (PROM) in abdominal cancer surgery, 1 while also offering an excellent example of student-driven, surgical research and stressing the importance of integrating medical students in a clinical trial.…”

Impact of an Operating Room Nurse Preoperative Dialogue on Anxiety, Satisfaction and Early Postoperative Outcomes in Patients Undergoing Major Visceral Surgery—A Single Center, Open-Label, Randomized Controlled Trial

“…After ERAS implementation, the philosophy is to strive for additional marginal gains, provided the interventions can be easily implemented into the complex perioperative care pathway. Nevertheless, our present intervention seems to target patient-reported outcome measures (PROMs) and PREMs more specifically than clinical postoperative outcomes [ 21 ]. Correlation between PROMs/PREMs and postoperative complications, however, seems weak.…”

“…Correlation between PROMs/PREMs and postoperative complications, however, seems weak. The recent PATRONUS study showed no correlation between postoperative complications and the PROMs evaluated in a large cohort of patients undergoing major oncologic surgery [ 21 ]. This data underline the different health perspectives between outcomes reported by the patient (PROMs/PREMs) and postoperative morbidity, usually reported by the physicians.…”

Using Drain-Free Flap Fixation Techniques Versus Traditional Wound Closure With Drain Placement to Prevent Seroma Formation and Its Complications in Breast Cancer Patients Undergoing Mastectomy: A Systematic Review and Meta-analysis

“…Recently, at least 17 studies have been conducted (Almond et al, 2010; Arafa et al, 2019; Awad et al, 2020; de Rooij et al, 2021; Eichler et al, 2016; Huang et al, 2021; Khater et al, 2015; Mazouni et al, 2015; Myint et al, 2020; Najeeb et al, 2019; Ohlinger et al, 2018; Ouldamer et al, 2015; Sakkary, 2012; ten Wolde et al, 2014; van Bastelaar et al, 2016, 2016; van Zeelst et al, 2022; Vettuparambil & Subramanya, 2021; Wu et al, 2020) comparing flap fixation techniques with conventional wound closure using a drain. In one systematic review, the researchers found that flap fixation using either quilting sutures or TissuGlu was more clinically effective than traditional wound closure with drain placement, but quilting sutures were not superior to the use of a surgical adhesive (CHIR-Net SIGMA Study Group & Mihaljevic, 2021). Other researchers have also reported a reduction in the incidence of seroma formation incidence when using flap fixation techniques (Awad et al, 2020; de Rooij et al, 2021; Khater et al, 2015; Myint et al, 2020; Ouldamer et al, 2015; Sakkary, 2012; ten Wolde et al, 2014; van Bastelaar et al, 2016; van Zeelst et al, 2022; Vettuparambil & Subramanya, 2021).…”

“…We found a statistically significant reduction in the incidence of seroma formation and surgical site infection in patients with breast cancer undergoing mastectomy using a flap fixation technique compared with drain placement. These results are based on several studies and have also been confirmed by another systematic review (CHIR-Net SIGMA Study Group & Mihaljevic, 2021); however, additional studies are warranted to evaluate other complications that will assist surgeons in making evidence-based decisions when performing mastectomy.…”