Markers of anastomotic leakage

Anastomotic leakage is one of the most dreaded complications following
colorectal surgery. Pathofysiology of anastomotic leakage is characterized by
intestinal content leaking into the abdominal cavity, resulting in
inflammation, sepsis, and eventually death. Diagnosis is challenging: clinical
signs and symptoms are often non-specific, leakage is frequently missed on CT
imaging and adequate laboratory tests are lacking. Therefore, sensitive and
specific markers are needed to detect anastomotic leakage early after
colorectal surgery. An accurate marker can improve clinical management.
Laparotomy or drainage of intraabdominale abcesses can be performed at an
earlier timepoint and needless surgery can be prevented, reducing morbidity and
mortality.

The aim of this pilotstudy is to find (an) accurate marker(s) of anastomotic
leakage at an early postoperative timepoint.

1) The highest incidence of anastomotic leakage is reported between
postoperative day 3 and 7. Therefore, venous blood is collected daily (2-3 ml
at a time), starting at day 0 (on which surgery is performed) until
postoperative day 7.
2) In patients with ostomy and great risk of anastomotic leakage (tumor < 6 cm
from the anorectal verge, history of smoking, alcohol abuse, preoperative
radio/chemotherapy), a cotton roll (diameter 1.5 cm) is inserted in the rectum
daily, starting at postoperative day 1 until postoperative day 7. The cotton
roll is inserted by a nurse in the morning and is removed at the end of the day
(about 8 hours in situ).
3) In patients in which ostomy is not performed, faeces is collected daily,
starting at postoperative day 1 until postoperative day 7.
4) In order to quantify intestinal tissue concentrations of the potential
markers, a small part (distal 2 cm) of the tissue specimen that is removed for
medical reasons, is stored at -80, and will be analyzed later on.

Voor de studie zal per patiënt 8 maal (veneus) bloed worden afgenomen. Minimaal
2 afnames hiervan zullen al gebeuren ten behoeve van de reguliere zorg. De
belasting en het risico van deze venapuncties is minimaal.
Voor de studie zal 7 dagen postoperatief rectaal een tampon worden ingebracht
(ongeveer 8 uur per dag). Het betreft een dunne tampon (ongeveer 1,5 cm
doorsnede). Het risico hiervan is minimaal, de belasting voor de patiënt kan
variëren van minimaal tot matig.

Venapunction is performed 8 times in each patient. At least 2 of these would
have been done for regular healthcare purposes. Minimal burden and risks is
associated with these venapunctions.
Daily insertion of a cotton roll in the rectum is performed daily during 7 days
(about 8 hours a day in situ). Minimal risk is associated with this procedure
and the burden per patient is considered minimal to moderate.