Official title: LAPAD - A prospective study on the effect of adhesiolysis during elective laparotomy or laparoscopy on per- and postoperative complication, quality of life and socioeconomic costs Background: With improved surgical technology and ageing of the population the number of reoperations in the abdomen dramatically increases. The risk for a repeat laparotomy or laparoscopy is a high as 30% in the first ten years after a laparotomy. In over 95% of reoperations adhesiolysis is required to gain access to the abdominal cavity and operation area. Adhesiolysis significantly increases the risk for inadvertent organ damage, such as enterotomies, leading to higher morbidity, mortality and socioeconomic costs. Purpose: To define the impact of adhesiolysis on per- and postoperative complications, quality of life and socioeconomic costs. Design: Prospective observational study. Primary outcomes: * adhesiolysis time * inadvertent enterotomy * seromuscular injury * miscellaneous organ damage * Serious adverse events of operation (anastomotic leakage, delayed diagnosed perforation, wound infection, abdominal infection, haemorrhage, pneumonia, urinary tract infection, abscess, fistula, sepsis, death) Secondary outcomes: * Hospital stay * Intensive care admission * Reinterventions * In-hospital costs * Parenteral feeding * Short term readmissions (30 days) * Quality of life (Gastro- intestinal tract complaints, Short Form- 36(SF-36), DASI (Duke Activity Score Index(DASI) ) Estimated enrollment: 800 start study: 1 june 2008 Inclusion completion date: 1 june 2010 Estimated study completion date: 1 february 2011
Study Type
OBSERVATIONAL
Enrollment
752
Blunt or sharp dissection of adhesive tissue.
Radboud University Nijmegen Medical Center
Nijmegen, Gelderland, Netherlands
Inadvertent Enterotomy
Every unintended and iatrogenic full thickness defect of the bowel.
Time frame: Day of surgery (one day)
Seromuscular Injury
Every visible damage to the serosa, without leakage or exposure of the bowel lumen.
Time frame: Day of surgery (one day)
Miscellaneous Organ Damage
Unintended iatrogenic damage to intra- peritoneal organs and structures other than bowel. E.g. Spleen, liver, pancreas or ureter.
Time frame: Day of surgery (one day)
Serious Adverse Events
Complications marked as SAE: anastomotic leakage, delayed diagnosed perforation, wound infection, abdominal infection, haemorrhage, pneumonia, urinary tract infection, abscess, fistula, sepsis, death
Time frame: 30 days
Adhesiolysis Time
Time required to dissect adhesive tissue.
Time frame: Day of surgery (one day)
Hospital stay
Number of days from surgery until discharge
Time frame: From surgery to discharge
Reinterventions
Emergency reoperation related to a complication of initial surgery within max. 30 days after discharge.
Time frame: 30 days after discharge
In- hospital Costs
Direct costs comprising costs from operation, stay on ward and Intesive Care Unit, medication use, diagnostics.
Time frame: From surgery to discharge
Parenteral Feeding
Number of days that patient required parenteral feeding.
Time frame: From surgery to discharge
Short term readmissions
Readmissions to the hospital related to complication of surgery.
Time frame: 30 days after discharge
Quality of life
Quality of life as measured with SF-36, Gastro- intestinal tract complaints and DASI index.
Time frame: 6 months post surgery
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