To investigate the feasibility of using L-PRP on anastomosis to prevent septic complications from occuring.
ID
Source
Brief title
Condition
- Anal and rectal conditions NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The occurrence of septic complications; anastomotic leak, presacral
abscess/sinus, perineal wound problems.
Secondary outcome
- Registration of other complications
- Cost-effectiveness analysis
Background summary
In Holland there is an increasing incidence of rectal cancer. Surgical
treatment of rectal cancer is a total mesorectal excision (TME). Within the
TME, an abdominoperineal resection (APR) of a low anterior resection (LAR) can
be performed. Concerning LAR, the continuity of the colon is restored by
establishing a low anastomosis. The most important problems after LAR are
septic complications as anastomotic leakage, abdominal or pelvic abscesses,
wound infections and and persisting presacral sinus.
The incidence of septic complications after LAR varies between 10 and 20
percent. Anastomotic leakage occurs in around 10 percent of the cases and goes
hand in hand with significant morbidity and mortality. The mortality rate for
an anastomotic leak is around 30 percent. To this day a proper solution for the
prevention of septic complications after LAR for rectal cancer still remains to
be found.
Promising results have been published concerning the role of Leucocytes -
Platelet Rich Plasma (L-PRP) in the process of wound healing. Our hypothesis is
that this will also be the case in the healing of the low anastomosis after low
anterior resection, and thus that L-PRP will help to prevent septic
complications from occuring in these patients.
Study objective
To investigate the feasibility of using L-PRP on anastomosis to prevent septic
complications from occuring.
Study design
Pilot study
Intervention
- The application of L-PRP in a single dose, applied onto the anastomosis
Study burden and risks
All patients will undergo the standardized low anterior resection with
omentoplasty. In all patients, a single dose of L-PRP will be applied onto the
anastomosis which has no additional risks. All patients will get the standard
follow-up after low anterior resection.
Henri Dunantstraat 5
Heerlen 6419 PC
NL
Henri Dunantstraat 5
Heerlen 6419 PC
NL
Listed location countries
Age
Inclusion criteria
Patients eligible for undergoing a low anterior resection
Exclusion criteria
Patients who are physically incapable of undergoing invasive surgery like low anterior resection
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL40558.096.12 |