Determination of Albumina as an Early Predictor of Postoperative Infections in Colorectal Surgery

NCT03643523 | Unknown

• 1 other identifier: ALB-CIR
• Study Type: observational
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

Colorectal surgery has traditionally been associated with significant morbidity and prolonged hospital stay. Overall complication rates have been reported to be 26-35%. Infectious complications, in particular, represent a major cause of morbidity and mortality after colorectal surgery. Postoperative intra-abdominal infections after colorectal surgery are mainly due to anastomotic leakage. They occur in 5 to 15% of patients and carry a short term mortality of around 20%. They also have a major impact on the outcome of surgery as they prolong in hospital stay, increase treatment costs and worsen long-term survival in cancer patients. If diagnosed early, they can be treated effectively and their impact on surgery outcome is thus minimised. There is a growing interest to find a biological marker useful for early detection of anastomotic leak; such a marker could play a pivotal role in the modern fast-track multimodal protocols, allowing safe and early discharge of patients after colorectal surgery. Although C reactive protein (CRP) and procalcitonin (PCT) have been proposed as predictors for adverse outcomes in colorectal surgery, they both display the critical limitations of slow kinetics. Conversely, serum albumin (ALB) is a maintenance protein that is rapidly down regulated by inflammatory signals. There some studies about the use of postoperative ALB drop as a marker of predictor for clinical outcome. These studies are either retrospective or mix patients with different types of surgical procedures performed. This study aimed to test the hypotheses that early postoperative albumin drop can predict anastomotic leaks and also can predict postoperative infectious complications earlier than other biological markers.

Conditions

Albumin; Double

Keywords

anastomitic leak, infectious complications, colorectal surgery

Outcome Measures

Primary Outcomes (1)

• Determination of serum albumine levels

  One year

Study Arms (1)

ALbumin level

Detection of serum albumin levels in postoperatory of colorectal surgery

Diagnostic Test: Albumine detection

Interventions

Albumine detection DIAGNOSTIC_TEST

Control of serum albumine levels in postoperatori of colorectal surgery

ALbumin level

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients operated on scheludec colorectal surgery with primary anastomosis

You may qualify if:

• Patients older than 18 years
• Patients undergoing major colorectal surgery (expected to last 2 hours or more)
• Performing primary anastomosis
• Scheluded surgery
• Patients who give their written informed consent

Sponsors & Collaborators

• Corporacion Parc Tauli: lead

Central Study Contacts

Mora Dr. Laura

CONTACT

34639101033; mora.lopez.laura@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: August 21, 2018
• First Posted: August 22, 2018
• Study Start: January 15, 2019
• Primary Completion: February 1, 2019
• Study Completion: December 31, 2019
• Last Updated: August 22, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share