A Prospective Study on the Effect of Adhesiolysis During Elective Laparotomy or Laparoscopy on Per- and Postoperative Complication, Quality of Life and Socioeconomic Costs
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tissue Adhesions
- Sponsor
- Radboud University Medical Center
- Enrollment
- 752
- Locations
- 1
- Primary Endpoint
- Inadvertent Enterotomy
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •Planned elective laparotomy or laparoscopy
- •Mentally competent
- •18 years or older
Exclusion Criteria
- •Operation cancelled
- •Bad quality of data
Outcomes
Primary Outcomes
Inadvertent Enterotomy
Time Frame: Day of surgery (one day)
Every unintended and iatrogenic full thickness defect of the bowel.
Seromuscular Injury
Time Frame: Day of surgery (one day)
Every visible damage to the serosa, without leakage or exposure of the bowel lumen.
Miscellaneous Organ Damage
Time Frame: Day of surgery (one day)
Unintended iatrogenic damage to intra- peritoneal organs and structures other than bowel. E.g. Spleen, liver, pancreas or ureter.
Serious Adverse Events
Time Frame: 30 days
Complications marked as SAE: anastomotic leakage, delayed diagnosed perforation, wound infection, abdominal infection, haemorrhage, pneumonia, urinary tract infection, abscess, fistula, sepsis, death
Adhesiolysis Time
Time Frame: Day of surgery (one day)
Time required to dissect adhesive tissue.
Secondary Outcomes
- Hospital stay(From surgery to discharge)
- Reinterventions(30 days after discharge)
- In- hospital Costs(From surgery to discharge)
- Parenteral Feeding(From surgery to discharge)
- Short term readmissions(30 days after discharge)
- Quality of life(6 months post surgery)