389
Participants
Start Date
March 1, 2018
Primary Completion Date
March 1, 2025
Study Completion Date
October 1, 2028
Routine follow-up
Patients visit the outpatient clinic twice a year during the first two to three years and annually thereafter, until five years postoperative. CEA-levels are determined at 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 48 and 60 months after primary resection. Detection of liver metastases with ultrasound or CT is performed at 12, 24, 36, 48 and 60 months postoperative. At 6 and 18 months postoperative, a CT-scan is part of the study protocol, but ultrasound of the liver is allowed for other time intervals during follow-up. Colonoscopy is performed at 12 and 48 months postoperative.
Second look DLS
Second look DLS is performed within one month from negative CT at 6-9 months (depending last date of adjuvant chemotherapy) and normal CEA. Laparoscopic access to the abdominal cavity is obtained under general anaesthesia, followed by adhesiolysis if necessary. Complete staging is performed, with biopsy of any lesion suspicious of PM, and determining the peritoneal cancer index (PCI) in case of PM. Conversion to laparotomy not allowed for better exposure, but only for intra-operative complications.
Third look DLS
Third look DLS is performed within one month from negative CT at 18 months and normal CEA. Laparoscopic access to the abdominal cavity is obtained under general anaesthesia, followed by adhesiolysis if necessary. Complete staging is performed, with biopsy of any lesion suspicious of PM, and determining the peritoneal cancer index (PCI) in case of PM. Conversion to laparotomy not allowed for better exposure, but only for intra-operative complications.
Flevoziekenhuis, Almere Stad
Amsterdam UMC, location AMC, Amsterdam
Amsterdam UMC, location VUmc, Amsterdam
Antoni van Leeuwenhoek, Amsterdam
OLVG, Amsterdam
Catharina hospital, Eindhoven
University Medical Center Groningen, Groningen
St. Antonius hospital, Nieuwegein
Radboudumc, Nijmegen
University Medical Center Utrecht, Utrecht
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER