Matthias Hornung, MD Study Director Dept. of Surgery, University Hospital Regensburg Jens M Werner, MD Principal Investigator Dept. of Surgery, University Hospital Regensburg
1. Disease free survival (Time Frame - Through study completion, an average of 3 years): Prospective analysis of disease free after CRS/HIPEC for peritoneal carcinomatosis
2. Overall survival (Time Frame - Through study completion, an average of 3 years): Prospective analysis of overall survival after CRS/HIPEC for peritoneal carcinomatosis
Secondary outcome:
1. Renal function (serum creatinine (mg/dl)) (Time Frame - Before as well as during the first 7 days postoperative): Screening for acute renal insufficiency by measuring serum chemistry (serum creatinine (mg/dl) before as well as during the first 7 postoperative days
2. Renal function (urea (mg/dl)) (Time Frame - Before as well as during the first 7 days postoperative): Screening for acute renal insufficiency by measuring serum chemistry (serum urea (mg/dl) before as well as during the first 7 days postoperative
3. Renal function (urine output (ml/24h)) (Time Frame - Before as well as during the first 7 days postoperative): Screening for acute renal insufficiency by measuring urine output (ml/24h) before as well as during the first 7 postoperative days
4. Microbiome (Bacterial 16S ribosomal RNA gene sequences will be amplified, sequenced, and analyzed in comparison to publicly available data obtained from healthy volunteers) (Time Frame - Before as well as at postoperative day 2 and 7): Longitudinal analysis of the microbial burden within samples will be quantified with droplet digital polymerase chain reaction. Bacterial 16S ribosomal RNA gene sequences will be amplified, sequenced, and analyzed in comparison to publicly available data obtained from healthy volunteers.
5. Cellular immune response (Frequency of NK cell subpopulations within lymphocyte populations measured by flow cytometry) (Time Frame - Before as well as at postoperative day 2 and 7): Longitudinal analysis of cellular immune responses in blood and peritoneal tissue by flow cytometry. Measuring frequency of NK cell populations within total lymphocyte population
6. Quality of life (Questionnaire-WHOQOL-BREF) (Time Frame - Before surgery and through study completion, an average of 3 years): Prospective analysis of quality of life after CRS/HIPEC for peritoneal carcinomatosis. Questionnaire-WHOQOL-BRE produces a quality of life profile. It is possible to derive four domain scores. There are also two items that are examined separately: question 1 asks about an individual's overall perception of quality of life and question 2 asks about an individual's overall perception of their health. The four domain scores denote an individual's perception of quality of life in each particular domain (Physical health (Score 7-35), Psychological (Score 6-30), Social relationships (Score 3-15), Environment (Score 8-40)). Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life). The mean score of items within each domain is used to calculate the domain score transformed to 4-20 or 20-100.
