Clinical trial NCT01236625: The Effect of Adhesiolysis During Elective Abdominal Surgery on Per- and Postoperative Complication, Quality of Life and Socioeconomic Costs
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tissue Adhesions
Keywords: Tissue Adhesions
Adhesiolysis
Inadvertent enterotomy
Prospective cohort study
Quality of life
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2010-11-07
Enrollment: 752
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patient undergoing elective laparotomy or laparoscopy in the department of surgery of the Radboud University Nijmegen Medical Centre (tertiary referral 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


Eligibility criteria: Inclusion Criteria:

* Planned elective laparotomy or laparoscopy
* Mentally competent
* 18 years or older

Exclusion Criteria:

* Operation cancelled
* Bad quality of data

Primary outcomes:
measure: Inadvertent Enterotomy
timeFrame: Day of surgery (one day)
measure: Seromuscular Injury
timeFrame: Day of surgery (one day)
measure: Miscellaneous Organ Damage
timeFrame: Day of surgery (one day)
measure: Serious Adverse Events
timeFrame: 30 days
measure: Adhesiolysis Time
timeFrame: Day of surgery (one day)
Secondary outcomes:
measure: Hospital stay
timeFrame: From surgery to discharge
measure: Reinterventions
timeFrame: 30 days after discharge
measure: In- hospital Costs
timeFrame: From surgery to discharge
measure: Parenteral Feeding
timeFrame: From surgery to discharge
measure: Short term readmissions
timeFrame: 30 days after discharge
measure: Quality of life
timeFrame: 6 months post surgery
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Center
state: Gelderland
Study officials:
affiliation: Radboud University Nijmegen Medical Center
name: Harry van Goor, MD, PhD, FRCS
role: STUDY_DIRECTOR
affiliation: Radboud University Nijmegen Medical Center
name: Richard PG ten Broek, BsC
role: PRINCIPAL_INVESTIGATOR
References:
citation: van Goor H. Consequences and complications of peritoneal adhesions. Colorectal Dis. 2007 Oct;9 Suppl 2:25-34. doi: 10.1111/j.1463-1318.2007.01358.x.
citation: 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. doi: 10.1046/j.1365-2168.2000.01394.x.
citation: 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. doi: 10.1007/BF02234701.
citation: Strik C, Stommel MW, Schipper LJ, van Goor H, Ten Broek RP. Risk factors for future repeat abdominal surgery. Langenbecks Arch Surg. 2016 Sep;401(6):829-37. doi: 10.1007/s00423-016-1414-3. Epub 2016 Apr 13.
citation: Strik C, Stommel MW, Schipper LJ, van Goor H, Ten Broek RP. Long-term impact of adhesions on bowel obstruction. Surgery. 2016 May;159(5):1351-9. doi: 10.1016/j.surg.2015.11.016. Epub 2016 Jan 6.
citation: Strik C, ten Broek RP, van der Kolk M, van Goor H, Bonenkamp JJ. Health-related quality of life and hospital costs following esophageal resection: a prospective cohort study. World J Surg Oncol. 2015 Sep 4;13:266. doi: 10.1186/s12957-015-0678-3.
citation: Strik C, Stommel MW, Ten Broek RP, van Goor H. Adhesiolysis in Patients Undergoing a Repeat Median Laparotomy. Dis Colon Rectum. 2015 Aug;58(8):792-8. doi: 10.1097/DCR.0000000000000405.
citation: ten Broek RP, Strik C, van Goor H. Preoperative nomogram to predict risk of bowel injury during adhesiolysis. Br J Surg. 2014 May;101(6):720-7. doi: 10.1002/bjs.9479.