Project Status

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Chief Investigators

Emergency laparotomy has been associated with high morbility  rate , long hospital stay and high mortality rate. A Retrospective study performed in USA with 37553 patients including in it,  showed a mortality rate of 14 percent after emergency laparotomy(1) . Other study in Danmark with 4920 patients in it, confirmed high mortality rate after emergency laparotomy , with a 19.5 percent (2).  A study designed in United Kingdom identified  the importance of emergency laparotomy cares standardisation to reduce high morbimortality rate(3). Implementation  of  enhancement recovery after surgery(ERAS) measures have been widely studied in elective surgery since Ljunquist deployed  them (4). ERAS measures scope within elective surgery has  dramatically reduced hospital stay by up to 30 percent without readmission increase. Medical postoperative complications have also declined with ERAS measures scope. But, nevertheless, these measures haven´t  been used as much in emergency surgery due to mainly , impossiblity of preoperative measures application because their emergency condition and on the other hand ,  patients´diversity, different comorbidities and different systemic impacts such as shock, sepsis and systemic inflammatory response syndrome(SIRS) ( 1, 5) . Use of ERAS measures  in patients suffering from colon obstruction due to neoplasm was associated  with a 20 percentage decrease of hospital stay. Postoperative complications decreased a 20 percentage in ERAS group compared with conventional measures in Clavien-Dindo scale type II, III and IV, although,  there weren´t significant (p=0.12)( 6) .ERAS measures aplication in colon cáncer obstruction has been studied in several studies. There are 3 cohort studies comparing ERAS vs conventional care in Emergency colon obstruction surgery ( 7. 8, 9). In all of them, a reduction of hospital stay was demostrated in ERAS group ( 2 days, 3 days and 3 days, respectively).  In the three studies, a postoperative complications decrease rate was shown.  Dimitrov et cols(10) study confirmed decrease rate in hospital stay and postoperative complications in ERAS Group in cáncer colon obstruction.

Hypothesis

This study has been designed to support the working hypothesis that emergency surgery in a colon obstruction neoplasm is better than stent bridge due to better oncological outcomes.

The primary objective is to  analyse the importance of ERAS program implementation in emergency colon obstruction surgery

The secondary objectives are to (1) the analysis of survival at 1 year, overall survival, disease-related survival and disease-free survival(2)  evaluate the relationship between stent bridge and colon perforation and   (3) evaluate the quality of life. The data generated from this prospective, multicentre, observational cohort study will help to verify or better understand the suspected benefits of ERAS protocols regarding long-term survival in patients who have undergone colorectal surgery. The data will also help future research studies.

Methods and Analisys

Design

A prospective, multicentre, observational cohort study in patients who meet the inclusion criteria.

Setting

This study will be conducted with different European hospitals promoved by Spanish multimodal rehabilitation group(GERM). All hospital selected received prior standarised the protocol of the study and they have to ask for local committee approbal

Inclusion criteria

• All adult patients (aged >18 years) with a diagnosis of Malignant obstruction  colorectal cancer. Informed consent will be obtained from all subjects who will participate in the study voluntarily.
• ASA I, II and III
• No more than 5 days from symptoms onset.
• Absence of proximal colon severe dilatation( no more than 8 centimeters), severe malnutrition.
•   No Inmunocompromised patients
•  Patients suffer from segmentary colectomy, with or without anastomosis with o witjhout lateral ileostomy
• Patients suffer from Hartmann procedure.

Exclusion criteria

• Patient refusal.
• Patients under 18 years of age.
•  ASA IV
•  Stent colocation
•  ICU stay more than 2 days
• Peritonitis
• Out of protocol  if patient would need total parenteral nutrition(NPT) during postoperative  or Clavien-Dindo more or equal  than II.

The research project will be monitored closely by a certified external auditor to ensure that study activities are carried out in accordance with the protocol, good clinical practice and applicable regulatory requirements. Local study documents can be selected for a local audit at participating hospitals. Data quality will also be audited