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

Radboud University Medical Center

Status: Completed

Conditions: Tissue Adhesions

Treatments: Procedure: Adhesiolysis

Study type: Observational

Funder types: Other

Identifiers

NCT01236625

RU-RTB-0003

Details and patient eligibility

About

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

Enrollment: 752 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Operation cancelled
• Bad quality of data

Trial design

752 participants in 2 patient groups

No adhesiolysis

Description:

All patient undergoing elective laparotomy or laparoscopy with no need for adhesiolysis during the procedure.

Adhesiolysis

Description:

All patient undergoing elective laparotomy or laparoscopy requiring adhesiolysis during the procedure.

Treatment:

Procedure: Adhesiolysis