Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT01236625
First received: November 4, 2010
Last updated: November 1, 2012
Last verified: September 2010
History of Changes
  Purpose

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


Condition Intervention
Tissue Adhesions
 Procedure: Adhesiolysis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:

MedlinePlus related topics: Adhesions
U.S. FDA Resources

Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Inadvertent Enterotomy [ Time Frame: Day of surgery (one day) ] [ Designated as safety issue: No ]
    Every unintended and iatrogenic full thickness defect of the bowel.

  • Seromuscular Injury [ Time Frame: Day of surgery (one day) ] [ Designated as safety issue: No ]
    Every visible damage to the serosa, without leakage or exposure of the bowel lumen.

  • Miscellaneous Organ Damage [ Time Frame: Day of surgery (one day) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    Time required to dissect adhesive tissue.


Secondary Outcome Measures:
  • Hospital stay [ Time Frame: From surgery to discharge ] [ Designated as safety issue: No ]
    Number of days from surgery until discharge

  • Reinterventions [ Time Frame: 30 days after discharge ] [ Designated as safety issue: No ]
    Emergency reoperation related to a complication of initial surgery within max. 30 days after discharge.

  • In- hospital Costs [ Time Frame: From surgery to discharge ] [ Designated as safety issue: No ]
    Direct costs comprising costs from operation, stay on ward and Intesive Care Unit, medication use, diagnostics.

  • Parenteral Feeding [ Time Frame: From surgery to discharge ] [ Designated as safety issue: No ]
    Number of days that patient required parenteral feeding.

  • Short term readmissions [ Time Frame: 30 days after discharge ] [ Designated as safety issue: No ]
    Readmissions to the hospital related to complication of surgery.

  • Quality of life [ Time Frame: 6 months post surgery ] [ Designated as safety issue: No ]
    Quality of life as measured with SF-36, Gastro- intestinal tract complaints and DASI index.


Enrollment: 752
Study Start Date: June 2008
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Operation cancelled
  • Bad quality of data
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01236625

Locations
Netherlands
Radboud University Nijmegen Medical Center
Nijmegen, Gelderland, Netherlands, 6500HB
Sponsors and Collaborators
Radboud University
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
  More Information

Additional Information:
main publication  This link exits the ClinicalTrials.gov site
publication as part of study  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT01236625     History of Changes
Other Study ID Numbers: RU-RTB-0003
Study First Received: November 4, 2010
Last Updated: November 1, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
Tissue Adhesions
Adhesiolysis
Inadvertent enterotomy
Prospective cohort study
Quality of life

Additional relevant MeSH terms:
Tissue Adhesions
Postoperative Complications
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013