In this study the effect of the pneumoperitoneum on the intestine of children is objectified by measuring the iFABP levels in the urine, as an indicator for the ischemia or damage to the intestine. To exclude any iFABP increase due to intestinal…
ID
Source
Brief title
Condition
- Gastrointestinal conditions NEC
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Peroperative measurements of:
• Urinary iFABP: as a measurement of the ischemia in the intestines (Detection
limit 40pg/ml pg/ml). Urinary samples are taken each 10 minutes during the
pneumoperitoneum, because of the half time of 11 minutes for iFABP. A control
sample is taken before the start of the pneumoperitoneum and the last sample is
taken 10 minutes after surgery.
• Urinary Creatinin: to calculate iFABP/ creatinin ratio (cut off point 2.2
pg/nmol). In the same samples as iFABP
• Intra-abdominal pressure and insufflation flow on monitor are registered in
the same 10 minutes interval as the urine samples
Secondary outcome
Post-operative measurement of:
• Urinary iFABP: Urinary samples by active urination of the patient, after the
removal of the urinary catheter (the time is noted), until 24h after the
surgery.
• Urinary Creatinin: In the same samples as iFABP
• Restoration of Gastro-intestinal function (per 6h in the first 24h; daily in
the first week) (First defecation, first oral feeding, and full oral feeding)
• Hospital stay in days
Background summary
During laparoscopic surgery there is a pneumoperitoneum created with carbon
dioxide to create a working space in the abdomen to visualize the target organs
and a proper operating field. An intra-abdominal pressure lower than 14 mmHg is
considered safe in a healthy adult patient, however, this in children lower
pressures are preferred, but there is no limit objectified in which
complications are more prone to occur.
The complications that can occur because of the pneumoperitoneum are based on
the physiological changes resulting from the increased abdominal pressure and
the carbon dioxide used to create the pneumoperitoneum. Low mesenteric blood
supply (due to high abdominal pressure) leads to intestinal injury and the
excretion of iFABP in the circulation. This substance will be excreted in the
urine, and the intestinal damage can be detected in the urine.
in this study the effect of the pneumoperitoneum on the paediatric intestine
will be objectified, in which urinary iFABP will serve as an indicator for
intestinal damage.
Study objective
In this study the effect of the pneumoperitoneum on the intestine of children
is objectified by measuring the iFABP levels in the urine, as an indicator for
the ischemia or damage to the intestine. To exclude any iFABP increase due to
intestinal damage of the surgical procedure (by manipulation and resection) we
chose to research these levels in children during a laparoscopic Nissen
fundoplication.
Primary Objective:
• Is there an effect of the pneumoperitoneum during laparoscopic procedures in
the paediatric intestine, by elevation in urinary iFABP concentration and
urinary iFABP/creatine ratio?
Secondary Objectives:
• Is there a relation between perioperative urinary iFABP concentration and
postoperative gastro-intestinal functions, measured by enteral feeding
postoperative?
• Is there a relation between perioperative urinary iFABP/creatine ratio and
postoperative gastro-intestinal functions, measured by enteral feeding
postoperative?
• Is there a relation between perioperative urinary iFABP concentration and
postoperative gastro-intestinal functions, measured by defecation habits
postoperative?
• Is there a relation between perioperative urinary iFABP/creatine ratio and
postoperative gastro-intestinal functions, measured by defecation habits
postoperative?
Study design
This is an observational prospective cohort study.
The urinary catheter is placed when the patient, and a control sample from the
urine is taken before the surgery. After the pneumoperitoneum is completed
there will be a sample taken every 10 minutes. The last sample during the
surgery is taken 10 minutes after the desufflation of the pneumoperitoneum. The
urinary bladder catheter is removed after the last sample, when the patient is
still under anaesthesia.
The other control measurements, such as intra-abdominal pressure, blood
pressure and urinary output are taken at the same interval points, during the
surgery. Postoperative gastro-intestinal measurements are documented at the
ward, and when the patient is released home, they will document this with their
parents on the questionnaire, for one week postoperative. Any complications
after the surgery will be documented for this research.
Study burden and risks
The patients will all receive a bladder catheter (CAD) just before the surgery
(when they are under anaesthesia), therefore, there will be no pain of
introducing the catheter. The CAD will stay in situ during the surgery and will
be removed before the patient is awake. The urinary samples can be drawn from
the CAD, which will cause no extra handling of the patient. The risks on
complications from a CAD (urinary track infection and false route) are low.
During regular elective laparoscopic Nissen fundoplication there is no specific
need for a CAD, however, the anaesthesiologist often requests this to have a
proper haemodynamic evaluation during the surgery. The insertion of a CAD
before the introduction of the trocars ensures the bladder to be empty, and
therefore, a safer introduction of the first subumbilical trocar.
The patients/ parents should also fill out a short questionnaire during one
week postoperative, on the enteral feeding and defecation of the patient.
By measuring the iFABP levels during the surgery in upper abdominal surgery (in
which the intestines are not manipulated) a clear effect of the
pneumoperitoneum on the paediatric intestine is visualized. This is useful for
the further use of the pneumoperitoneum and perhaps adaptation of the
insufflation pressures during the laparoscopic procedures in children.
P Debyelaan 25
6229 HX Maastricht
NL
P Debyelaan 25
6229 HX Maastricht
NL
Listed location countries
Age
Inclusion criteria
Age <16 years
Elective laparoscopic Nissen fundoplication
Exclusion criteria
Diagnosis of necrotizing enterocolitis, because of prior elevated iFABP
Emergency surgery
Inflammatory bowel disease, or other bowel disorders, which can cause iFABP elevations.
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 | NL35743.068.11 |