LAPAD: The Effect of Adhesiolysis During Elective Abdominal Surgery on Per- and Postoperative Complication, Quality of Life and Socioeconomic Costs
Study Details
Study Description
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:
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adhesiolysis time
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inadvertent enterotomy
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seromuscular injury
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miscellaneous organ damage
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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:
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Hospital stay
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Intensive care admission
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Reinterventions
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In-hospital costs
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Parenteral feeding
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Short term readmissions (30 days)
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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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No adhesiolysis All patient undergoing elective laparotomy or laparoscopy with no need for adhesiolysis during the procedure. |
|
| Adhesiolysis All patient undergoing elective laparotomy or laparoscopy requiring adhesiolysis during the procedure. |
Procedure: Adhesiolysis
Blunt or sharp dissection of adhesive tissue.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Planned elective laparotomy or laparoscopy
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Mentally competent
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18 years or older
Exclusion Criteria:
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Operation cancelled
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Bad quality of data
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Radboud University Nijmegen Medical Center | Nijmegen | Gelderland | Netherlands | 6500HB |
Sponsors and Collaborators
- Radboud University Medical Center
Investigators
- Study Director: Harry van Goor, MD, PhD, FRCS, Radboud University Nijmegen Medical Center
- Principal Investigator: Richard PG ten Broek, BsC, Radboud University Nijmegen Medical Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Parker MC, Ellis H, Moran BJ, Thompson JN, Wilson MS, Menzies D, McGuire A, Lower AM, Hawthorn RJ, O'Briena F, Buchan S, Crowe AM. Postoperative adhesions: ten-year follow-up of 12,584 patients undergoing lower abdominal surgery. Dis Colon Rectum. 2001 Jun;44(6):822-29; discussion 829-30.
- Van Der Krabben AA, Dijkstra FR, Nieuwenhuijzen M, Reijnen MM, Schaapveld M, Van Goor H. Morbidity and mortality of inadvertent enterotomy during adhesiotomy. Br J Surg. 2000 Apr;87(4):467-71.
- van Goor H. Consequences and complications of peritoneal adhesions. Colorectal Dis. 2007 Oct;9 Suppl 2:25-34. Review.
- RU-RTB-0003