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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Surgical Complications Relaparotomy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chirurgia Generale e d'Urgenza; Ospedale SG Bosco: aslTO2, Torino, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Post operative period of abdominal surgery (elective surgery of:colon-rectum, ileum, stomach and, pancreas)
Post operative period after Urgent laparotomy for both traumatic and/or non traumatic acute abdomen
Patients with signs of sepsis in the post operative period
Patients with signs of systemic hypoperfusion in the post operative

Exclusion criteria

Liver surgery
Drainage of bile, blood and dejection from abdominal drainage
Sepsis/ systemic hypoperfusion due to extraabdominal infection site

Sponsors and collaborators

Lead sponsor

Ospedale S. Giovanni Bosco

Other

Registry information

Official study title

Peritoneal/Serum Lactate Ratio in Relaparotomy

Acronym: lactate

Important dates

Study start: 2010
Primary completion: 2010
Study completion: 2010
First posted: Jul 14, 2010
Registry last updated: Jan 4, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed