Patient number
Item
Patient number
integer
C1830427 (UMLS CUI [1])
CRF number
Item
CRF number
integer
C1516308 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Date
Item
Date of visit
date
C0011008 (UMLS CUI [1])
Surgery date
Item
Date of surgery
date
C0011008 (UMLS CUI [1])
Surgery Start time
Item
Please give the time the surgery procedure started
time
C0543467 (UMLS CUI [1,1])
C2114713 (UMLS CUI [1,2])
Surgery end time
Item
Please give the time the surgical procedure was completed
time
C0543467 (UMLS CUI [1,1])
C2711097 (UMLS CUI [1,2])
Time from incision to suture
Item
Time from incision to suture
float
C2116297 (UMLS CUI [1,1])
C0009068 (UMLS CUI [1,2])
Hysterectomy
Item
Type of surgery:Hysterectomy
boolean
C0020699 (UMLS CUI [1])
Salpingo-oophorectomy
Item
Type of surgery:unilateral salpingo-oophorectomy
boolean
C0041692 (UMLS CUI [1])
Salpingo-oophorectomy
Item
Type of surgery:bilateral salpingectomy with oophorectomy
boolean
C0195495 (UMLS CUI [1])
Right hemicolectomy
Item
Type of surgery: Right hemicolectomy
boolean
C0192861 (UMLS CUI [1])
Transverse colectomy
Item
Type of surgery:Transverse colectomy
boolean
C0192863 (UMLS CUI [1])
Left colectomy
Item
Type of surgery: left colectomy
boolean
C0192865 (UMLS CUI [1])
Stripping of pelvic peritoneum
Item
Type of surgery: Stripping of pelvic peritoneum
boolean
C0230295 (UMLS CUI [1,1])
C0185047 (UMLS CUI [1,2])
Excision of periaortic lymph nodes
Item
Type of surgery: Excision of periaortic lymph nodes
boolean
C0193874 (UMLS CUI [1])
Appendectomy
Item
Type of surgery: Appendectomy
boolean
C0003611 (UMLS CUI [1])
Splenectomy
Item
Type of surgery:Splenectomy
boolean
C0037995 (UMLS CUI [1])
Rectosigmoidectomy
Item
Type of surgery: Rectosigmoidectomy
boolean
C0193063 (UMLS CUI [1])
Colostomy
Item
Type of surgery: Colostomy Procedure
boolean
C0009410 (UMLS CUI [1])
Resection of small intestines
Item
Type of surgery: Resection of small intestines
boolean
C0192571 (UMLS CUI [1])
Diaphragm stripping
Item
Type of surgery: Diaphragm stripping
boolean
C0198438 (UMLS CUI [1,1])
C0185047 (UMLS CUI [1,2])
Omentectomy
Item
Type of surgery: supracolic omentectomy
boolean
C0198614 (UMLS CUI [1,1])
C0446612 (UMLS CUI [1,2])
Omentectomy
Item
Type of surgery:infracolic omentectomy
boolean
C0456314 (UMLS CUI [1])
Pelvic lymph node excision
Item
Type of surgery:Complete pelvic lymph node excision
boolean
C0398429 (UMLS CUI [1])
Lymph node sampling
Item
Type of surgery:Sampling of lymph node
boolean
C0398417 (UMLS CUI [1])
Other surgery
Item
Please specifiy any other type of surgery performed
text
C0205394 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
Item
Was there a residue after surgery?
text
C0543478 (UMLS CUI [1])
Code List
Was there a residue after surgery?
CL Item
makroscopic no residue (0)
CL Item
<1cm residual tumor (1)
CL Item
≥1cm residual tumor (2)
Item
Outcome of surgery and HIPEC
text
C0184788 (UMLS CUI [1])
Code List
Outcome of surgery and HIPEC
CL Item
without complications (1)
CL Item
with complications (Please fill in AE-Form and specify complications below) (2)
Surgery outcome
Item
Please specify any complications during surgery and HIPEC such as: i.e adhesions
text
C0184788 (UMLS CUI [1])
Tumor biopsy
Item
Biopsy sample of tumor tissue collected (separate consent required)
boolean
C0677862 (UMLS CUI [1])
Procedure performed
Item
Has the HIPEC Procedure been performed? If "No", please specify the reason why below.
boolean
C0184661 (UMLS CUI [1,1])
C0884358 (UMLS CUI [1,2])
Procedure not performed
Item
Please specify the reason why the HIPEC-Procedure has not been performed
text
C0184661 (UMLS CUI [1,1])
C0445106 (UMLS CUI [1,2])
Procedure date
Item
Date the HIPEC-Procedure has been performed
date
C0184661 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Procedure Start time
Item
Time procedure was started
time
C0184661 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Procedure end time
Item
Time procedure was completed
time
C0184661 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
Used dose in planned escalation scheme
text
C3816728 (UMLS CUI [1])
Code List
Used dose in planned escalation scheme
CL Item
II/II 80mg/sqm (2)
CL Item
III/III 100mg/sqm (3)
Dose escalation
Item
Total dose applied (calculated from dose in mg multiplicated with body surface in square meter)
integer
C3816728 (UMLS CUI [1])
Reaction
Item
Was there a reaction during application? If "yes", please fill in AE form
boolean
C0443286 (UMLS CUI [1])
Total volume applied
Item
Please give the total volume applied during perfusion
integer
C2826310 (UMLS CUI [1])
Comments
Item
Please specify any particularities occurred during HIPEC Procedure
text
C0947611 (UMLS CUI [1])
Blood sampling
Item
Blood sampling to validate concentration of cisplatin (ng/ml)
boolean
C0005834 (UMLS CUI [1])
Item
Measuring point (from start of perfusion)
text
C0242485 (UMLS CUI [1,1])
C1442880 (UMLS CUI [1,2])
Code List
Measuring point (from start of perfusion)
CL Item
0min (before application of chemo) (1)
Measuring point
Item
Measuring point valid?
boolean
C0242485 (UMLS CUI [1,1])
C1442880 (UMLS CUI [1,2])
Concentration of Cisplatin
Item
Concentration of Cisplatin
text
C0365714 (UMLS CUI [1])
Comments
Item
Comments on any particularities during blood sampling and testing. Please specify measuring point
text
C0947611 (UMLS CUI [1])
Sample of perfusate
Item
Sample of perfusate taken?
boolean
C0200345 (UMLS CUI [1,1])
C0029704 (UMLS CUI [1,2])
Item
Measuring point (from start of perfusion)
text
C0242485 (UMLS CUI [1,1])
C1442880 (UMLS CUI [1,2])
Code List
Measuring point (from start of perfusion)
CL Item
0min (before application of chemo) (1)
Measuring point
Item
Measuring point valid?
boolean
C0242485 (UMLS CUI [1,1])
C1442880 (UMLS CUI [1,2])
Concentration of Cisplatin
Item
Concentration of Cisplatin
text
C0365714 (UMLS CUI [1])
Comments
Item
Comments on any particularities during perfusate sampling and testing. Please specify measuring point
text
C0947611 (UMLS CUI [1])
CTCAE
Item
Recording of CTCAE: Have any AE occurred perioperative or since the last Visit? If "Yes" please fill in AE-Form
boolean
C1516728 (UMLS CUI [1])
Concomitant agent
Item
Has concomitant medication been subject to change? If "Yes" please fill in Concomitant medication form.
boolean
C2347852 (UMLS CUI [1])
Confirmation
Item
Confirmatin of investigator: I hereby confirm that I personally checked this CRF for completeness and correctness. All data and statements in this CRF are ,according to best knowlwdge ,complete and correct.
boolean
C0750484 (UMLS CUI [1])
Name of Investigator
Item
Name of Investigator
text
C2826892 (UMLS CUI [1])
Signature
Item
Signature of investigator
text
C1519316 (UMLS CUI [1])
Date of completion
Item
Date of completion of this form
date
C0011008 (UMLS CUI [1])