To determine the kinetics of several immune cell subsets to evaluate the immune response to tissue damage and surgical manipulation caused by laparoscopic surgery. Additionally we aim to identify prognostic parameters for postoperative ileus, which…
ID
Source
Brief title
Condition
- Gastrointestinal motility and defaecation conditions
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Absolute cell numbers of different leukocyte populations in peripheral blood.
The studied populations will consist of T-cells (both CD4+ and CD8+), B-cells,
NK-cells, Neutrophils, Eosinophils, Basophils and monocytes.
Secondary outcome
- Comparison of leukocyte subset kinetics between patients that got a
(prolonged) postoperative ileus and those that didn*t after elective
laparoscopic hemi- or partial colectomy for malignancy.
- First bowel sound, tolerance of oral food intake, passage of defecation and
passage of flatus after surgery
- Postoperative opioid consumption
- Patient characteristics: Date of birth, date of operation, age, sex, length,
weight, BMI, ASA-score, diabetes mellitus, smoking status, alcohol abuse,
preoperative medication use (antihypertensiva, antihypercholestrolemia,
corticosteroids, anticoagulants, NSAID*s), cardiac history, cardiac symptoms,
peripheral arterial disease, pulmonary history, pulmonary symptoms,
preoperative ileus, neoadjuvant radiotherapy, neoadjuvant chemo-radiation,
bowel preparation, prophylactic antibiotics.
- Surgical characteristics: Type of surgery, anastomosis (type, primary,
configuration, location, stapled/hand-sewed, omentoplasty), operation
indication, operation time, anaesthesia, intra-operative complications, blood
loss, date of admission, date of discharge, duration of hospitalization, drain
(place, type), stoma (place, type), donuts, air-leaking test (including
outcome), surgeons (amount and expertise) and postoperative complications.
Background summary
Postoperative ileus (POI) is a transient impairment of bowel motility and is an
important clinical problem that commonly arises after colorectal surgery and
usually presents with intolerance of oral food intake, abdominal distension,
nausea, vomiting, and absence of flatus and defecation. POI is considered to be
a physiological response to the surgical procedure. However, in approximately
30% of patients POI is prolonged, causing a significant increase in patient
pain and discomfort, morbidity, hospitalization days and health care costs
Both the innate and adaptive immune system have been shown to play an important
role in the development of POI. Unravelling the interactions and kinetics of
the involved leukocytes is of great importance to understand the mechanism
underlying generalized impairment of gut motility after surgery. Therefore the
aim of this study is to systematically investigate the immune response
following abdominal surgery, through advanced and innovative multicolour
(8-12-color) flow cytometry.
Study objective
To determine the kinetics of several immune cell subsets to evaluate the immune
response to tissue damage and surgical manipulation caused by laparoscopic
surgery. Additionally we aim to identify prognostic parameters for
postoperative ileus, which is caused by massive influx of immune cell subsets
to the interstitium of the intestine.
Study design
Proof of concept/pilot prospective cohort study
Study burden and risks
There is no serious extra risk for a patient that is participating is this
trial and no potential benefit from participating. Venepunction risks are
minimal.
Wytemaweg 80
Rotterdam 3015 CN
NL
Wytemaweg 80
Rotterdam 3015 CN
NL
Listed location countries
Age
Inclusion criteria
- elective laparoscopic hemi- or partial colectomy with an anastomosis for colorectal carcinoma or elective laparoscopic liver resection for benign or oncological indication
- >18 years of age
- signed informed consent
Exclusion criteria
- pre-existing immune deficiency
- use of immunosuppressant drugs
- previous colorectal resection or (chemo)radiation
- previous major liver surgery
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 | NL59338.078.16 |