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

Tissue Adhesions Clinical Trial

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

Status Completed

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

Clinical Trial Description

n/a

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Postoperative Complications
• Tissue Adhesions

• NCT number: NCT01236625
• Study type: Observational
• Source: Radboud University
• Status: Completed
• Phase: N/A
• Start date: June 2008
• Completion date: February 2011