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

Tissue Adhesions Clinical Trial

— LAPAD  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01236625
• Other study ID #: RU-RTB-0003
• Status: Completed
• Phase: N/A
• First received: November 4, 2010
• Last updated: November 1, 2012
• Start date: June 2008
• Est. completion date: February 2011

Study information

• Verified date: September 2010
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 752
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Planned elective laparotomy or laparoscopy

• Mentally competent

• 18 years or older

Exclusion Criteria:

• Operation cancelled

• Bad quality of data

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Postoperative Complications
• Tissue Adhesions

Intervention

Procedure:
• Adhesiolysis
Blunt or sharp dissection of adhesive tissue.

Locations

Country	Name	City	State
Netherlands	Radboud University Nijmegen Medical Center	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

References & Publications (3)

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. — View 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. — View Citation

van Goor H. Consequences and complications of peritoneal adhesions. Colorectal Dis. 2007 Oct;9 Suppl 2:25-34. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inadvertent Enterotomy	Every unintended and iatrogenic full thickness defect of the bowel.	Day of surgery (one day)	No
Primary	Seromuscular Injury	Every visible damage to the serosa, without leakage or exposure of the bowel lumen.	Day of surgery (one day)	No
Primary	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)	No
Primary	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	No
Primary	Adhesiolysis Time	Time required to dissect adhesive tissue.	Day of surgery (one day)	No
Secondary	Hospital stay	Number of days from surgery until discharge	From surgery to discharge	No
Secondary	Reinterventions	Emergency reoperation related to a complication of initial surgery within max. 30 days after discharge.	30 days after discharge	No
Secondary	In- hospital Costs	Direct costs comprising costs from operation, stay on ward and Intesive Care Unit, medication use, diagnostics.	From surgery to discharge	No
Secondary	Parenteral Feeding	Number of days that patient required parenteral feeding.	From surgery to discharge	No
Secondary	Short term readmissions	Readmissions to the hospital related to complication of surgery.	30 days after discharge	No
Secondary	Quality of life	Quality of life as measured with SF-36, Gastro- intestinal tract complaints and DASI index.	6 months post surgery	No

External Links

•   main publication
•   publication as part of study