The Effect of Adhesiolysis During Elective Abdominal Surgery on Per- and Postoperative Complication, Quality of Life and Socioeconomic Costs

Study Overview
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Brief Summary
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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

Official Title
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A Prospective Study on the Effect of Adhesiolysis During Elective Laparotomy or Laparoscopy on Per- and Postoperative Complication, Quality of Life and Socioeconomic Costs

Conditions
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Tissue Adhesions

Intervention / Treatment
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* Procedure: Adhesiolysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Planned elective laparotomy or laparoscopy Mentally competent 18 years or older Exclusion Criteria: Operation cancelled Bad quality of data

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No adhesiolysis<br>All patient undergoing elective laparotomy or laparoscopy with no need for adhesiolysis during the procedure. | |
| Adhesiolysis<br>All patient undergoing elective laparotomy or laparoscopy requiring adhesiolysis during the procedure. | Procedure: Adhesiolysis<br>* Blunt or sharp dissection of adhesive tissue.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inadvertent Enterotomy | Every unintended and iatrogenic full thickness defect of the bowel. | Day of surgery (one day) | 
| Seromuscular Injury | Every visible damage to the serosa, without leakage or exposure of the bowel lumen. | 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. | 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 | 30 days | 
| Adhesiolysis Time | Time required to dissect adhesive tissue. | Day of surgery (one day) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital stay | Number of days from surgery until discharge | From surgery to discharge | 
| Reinterventions | Emergency reoperation related to a complication of initial surgery within max. 30 days after discharge. | 30 days after discharge | 
| In- hospital Costs | Direct costs comprising costs from operation, stay on ward and Intesive Care Unit, medication use, diagnostics. | From surgery to discharge | 
| Parenteral Feeding | Number of days that patient required parenteral feeding. | From surgery to discharge | 
| Short term readmissions | Readmissions to the hospital related to complication of surgery. | 30 days after discharge | 
| Quality of life | Quality of life as measured with SF-36, Gastro- intestinal tract complaints and DASI index. | 6 months post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tissue Adhesions, Adhesiolysis, Inadvertent enterotomy, Prospective cohort study, Quality of life