Influence of intraperitoneal application of taurolidine on the perioperative metastases, tumor recurrence and survival rate after surgical resection of colorectal cancer

ISRCTN	ISRCTN43522674
DOI	https://doi.org/10.1186/ISRCTN43522674
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Prof Christoph Andreas Jacobi
Scientific

Charité - University Medicine Berlin
Department of Surgery
Schumannstraße 20/21
Berlin
10117
Germany

Phone	+49 30450522031
Email	christoph.jacobi@charite.de

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study acronym	IPAT-MET
Study objectives	Recurrence rates after colon resection for cancer are 16% to 18% (Surgical Therapy Study Group). The study hypothesis is that the intraoperative intraperitoneal lavage with taurolidine reduces the 5-year recurrence rate from 16% to 10%.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Colorectal cancer
Intervention	2000 patients with colorectal cancer will be randomised to receive either taurolidine or NaCl solution during resection. Tumor recurrence, metastases and survival rates will be investigated up to 5 years. Intraoperative instillation of 1% taurolidine versus 0.9% NaCl solution, evaluation of morbidity and mortality, side-effects, long-term follow-up after 3, 6, 12 month and 2, 3, 4 and 5 years.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Taurolidine
Primary outcome measure	Time to local and distant tumor relapse (disease free survival).
Secondary outcome measures	Global survival time.
Overall study start date	01/06/2005
Completion date	31/12/2006

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	2000
Key inclusion criteria	Patients with colorectal cancer and curative resection, age over 18 years, American Society of Anesthesiologists (ASA) classification <IV.
Key exclusion criteria	1. Ileus 2. Peritoneal carcinomatosis 3. Intraperitoneal abscess formation 4. Intestinal perforation 5. Peritonitis 6. Sepsis 7. Organ falure 8. ASA classification IV 9. R1 or R2 resection
Date of first enrolment	01/06/2005
Date of final enrolment	31/12/2006

Charité - University Medicine Berlin

Berlin
10117
Germany

Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
University/education

Department of Surgery
Schumannstraße 20/21
Berlin
10117
Germany

"ROR"	https://ror.org/001w7jn25

Industry

Funding of the Insurance (Gehrling-Konzern) Vers.Nr.: 70-5644584-4 by Böhringer Ingelheim (Germany)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan