The Effect of Adhesiolysis During Elective Abdominal Surgery on Per- and Postoperative Complication, Quality of Life and Socioeconomic Costs
- Conditions
- Tissue Adhesions
- Interventions
- Procedure: Adhesiolysis
- Registration Number
- NCT01236625
- Lead Sponsor
- Radboud University Medical Center
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 752
- Planned elective laparotomy or laparoscopy
- Mentally competent
- 18 years or older
- Operation cancelled
- Bad quality of data
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Adhesiolysis Adhesiolysis All patient undergoing elective laparotomy or laparoscopy requiring adhesiolysis during the procedure.
- Primary Outcome Measures
Name Time Method Inadvertent Enterotomy Day of surgery (one day) Every unintended and iatrogenic full thickness defect of the bowel.
Seromuscular Injury Day of surgery (one day) Every visible damage to the serosa, without leakage or exposure of the bowel lumen.
Miscellaneous Organ Damage 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 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 Day of surgery (one day) Time required to dissect adhesive tissue.
- Secondary Outcome Measures
Name Time Method Hospital stay From surgery to discharge Number of days from surgery until discharge
Reinterventions 30 days after discharge Emergency reoperation related to a complication of initial surgery within max. 30 days after discharge.
In- hospital Costs From surgery to discharge Direct costs comprising costs from operation, stay on ward and Intesive Care Unit, medication use, diagnostics.
Parenteral Feeding From surgery to discharge Number of days that patient required parenteral feeding.
Short term readmissions 30 days after discharge Readmissions to the hospital related to complication of surgery.
Quality of life 6 months post surgery Quality of life as measured with SF-36, Gastro- intestinal tract complaints and DASI index.
Trial Locations
- Locations (1)
Radboud University Nijmegen Medical Center
🇳🇱Nijmegen, Gelderland, Netherlands