The Effect of Adhesiolysis During Elective Abdominal Surgery on Per- and Postoperative Complication, Quality of Life and Socioeconomic Costs (LAPAD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01236625|
Recruitment Status : Completed
First Posted : November 8, 2010
Last Update Posted : November 2, 2012
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
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.
To define the impact of adhesiolysis on per- and postoperative complications, quality of life and socioeconomic costs.
Prospective observational study.
- 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)
- Hospital stay
- Intensive care admission
- 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
|Condition or disease||Intervention/treatment|
|Tissue Adhesions||Procedure: Adhesiolysis|
|Study Type :||Observational|
|Actual Enrollment :||752 participants|
|Official Title:||A Prospective Study on the Effect of Adhesiolysis During Elective Laparotomy or Laparoscopy on Per- and Postoperative Complication, Quality of Life and Socioeconomic Costs|
|Study Start Date :||June 2008|
|Actual Primary Completion Date :||February 2011|
|Actual Study Completion Date :||February 2011|
All patient undergoing elective laparotomy or laparoscopy with no need for adhesiolysis during the procedure.
All patient undergoing elective laparotomy or laparoscopy requiring adhesiolysis during the procedure.
Blunt or sharp dissection of adhesive tissue.
- 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.
- Hospital stay [ Time Frame: From surgery to discharge ]Number of days from surgery until discharge
- Reinterventions [ Time Frame: 30 days after discharge ]Emergency reoperation related to a complication of initial surgery within max. 30 days after discharge.
- In- hospital Costs [ Time Frame: From surgery to discharge ]Direct costs comprising costs from operation, stay on ward and Intesive Care Unit, medication use, diagnostics.
- Parenteral Feeding [ Time Frame: From surgery to discharge ]Number of days that patient required parenteral feeding.
- Short term readmissions [ Time Frame: 30 days after discharge ]Readmissions to the hospital related to complication of surgery.
- Quality of life [ Time Frame: 6 months post surgery ]Quality of life as measured with SF-36, Gastro- intestinal tract complaints and DASI index.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01236625
|Radboud University Nijmegen Medical Center|
|Nijmegen, Gelderland, Netherlands, 6500HB|
|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|