Surgical Complications Clinical Trial
Official title:
Peritoneal/Serum Lactate Ratio in Relaparotomy
Laparotomy performed for both emergency of elective surgery may by complicated by
intrabdominal collection, anastomotic leakage, infarction and others. This conditions are
able to induce peritoneal inflammation. Inflamed peritoneum are able to produce excess of
lactate that the investigators can measure by collecting fluid from peritoneal drainage.
Drainage were left in abdomen for monitoring intrabdominal condition until the passage of
stool or flatus. Minimum drainage of serum is present daily also in uncomplicated post
operative period.
Serum lactate relates with increased systemic anaerobic metabolism such as SIRS, sepsis and
systemic hypoperfusion and it is easy to measure with a blood gas analysis.
The investigators hypothesized that the increases of peritoneal/ serum lactate ratio could
be an earlier, sensible, non-invasive, and economical marker of post surgical complications.
The decision whether and when to perform a relaparotomy in secondary peritonitis is largely
subjective and based on professional experience. Actually no existing scoring system aids in
this decision.
The aim of this study is to demonstrate that this ratio could be and useful tool for the
surgeon in this decisional process.
Post operative intraabdominal sepsis due to surgical complications is associated with an
important mortality and morbidity. Early diagnosis is crucial to improve outcome.
Relaparotomy could be necessary to eradicate the intraabdominal focus of sepsis or
hypoperfusion. The relaparotomy must be performed early after the diagnosis of surgical
complications before the onset of multi organ failure.
This prospective observational study includes the post operative period of consecutive
patients requiring both major elective surgery and urgent laparotomy.
Demographic data, presence and nature of underlying disease and surgical diagnosis will be
recorded on admission and study inclusion.
Daily after study inclusion, the investigators measure: venous blood gases, blood lactate
and lactate presents in the fluid collected from the abdomen. Possum and SAPSII scores will
be calculated daily or when a patient develops a rapid clinical deterioration.
The investigators follow patients with complicated or uncomplicated post operative period.
Post operative complications are defined as: mesenteric ischemia, need for reintervention,
anastomotic leakage or fistula, secondary peritonitis and death.
The primary end point is to demonstrate the correlation between surgical complications and
serum/abdominal lactate ratio.
The second end point is to verify the correlation between need to relaparotomy and Possum an
SAPSII scores.
;
Time Perspective: Prospective
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01612754 -
Prospective Trial on Noise Reduction in Surgical Operating Theaters
|
N/A | |
Completed |
NCT01593657 -
Mindful Movement and Breathing to Improve Outcomes of Gynecologic Surgery
|
N/A | |
Completed |
NCT04281680 -
Impact of Pasireotide on Postoperative Pancreatic Fistulas Following Distal Resections
|
||
Active, not recruiting |
NCT04487548 -
Perioperative Smoking Cessation BUndle in a Tertiary Care Hospital - Can Turning Virtual Improve Outcomes?
|
N/A |