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

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

Study Overview

• Status: Completed
• Conditions: Tissue Adhesions
• Intervention / Treatment: Procedure: Adhesiolysis

• Study Type: Observational
• Enrollment (Actual): 752

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6500HB
      • Radboud University Nijmegen Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Operation cancelled
• Bad quality of data

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General 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. doi: 10.1007/BF02234701.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Helpful Links

• main publication
• publication as part of study

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: November 4, 2010
• First Submitted That Met QC Criteria: November 5, 2010
• First Posted (Estimate): November 7, 2010

Study Record Updates

• Last Update Posted (Estimate): November 2, 2012
• Last Update Submitted That Met QC Criteria: November 1, 2012
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: Quality of life; Adhesiolysis; Prospective cohort study; Tissue Adhesions; Inadvertent enterotomy
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix; Postoperative Complications; Tissue Adhesions
• Other Study ID Numbers: RU-RTB-0003