NCT01236625

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
752

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

November 4, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 8, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

November 2, 2012

Status Verified

September 1, 2010

Enrollment Period

2.7 years

First QC Date

November 4, 2010

Last Update Submit

November 1, 2012

Conditions

Tissue Adhesions

Keywords

Tissue AdhesionsAdhesiolysisInadvertent enterotomyProspective cohort studyQuality of life

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (6)

  • Hospital stay

    From surgery to discharge

  • Reinterventions

    30 days after discharge

  • In- hospital Costs

    From surgery to discharge

  • Parenteral Feeding

    From surgery to discharge

  • Short term readmissions

    30 days after discharge

  • +1 more secondary outcomes

Study Arms (2)

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

Interventions

AdhesiolysisPROCEDURE

Blunt or sharp dissection of adhesive tissue.

Adhesiolysis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patient undergoing elective laparotomy or laparoscopy in the department of surgery of the Radboud University Nijmegen Medical Centre (tertiary referral center).

You may qualify if:

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

You may not qualify if:

  • Operation cancelled
  • Bad quality of data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Nijmegen Medical Center

Nijmegen, Gelderland, 6500HB, Netherlands

Location

Related Publications (10)

  • 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.

    PMID: 17824967BACKGROUND

  • 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.

    PMID: 10759744BACKGROUND

  • 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.

    PMID: 11391142BACKGROUND

  • Gawria L, Krielen P, Stommel MWJ, van Goor H, Ten Broek RPG. Reproducibility and predictive value of three grading systems for intraoperative adverse events in a cohort of abdominal surgery. Int J Surg. 2024 Jan 1;110(1):202-208. doi: 10.1097/JS9.0000000000000428.

    PMID: 38000068DERIVED

  • van den Beukel BAW, Toneman MK, van Veelen F, van Oud-Alblas MB, van Dongen K, Stommel MWJ, van Goor H, Ten Broek RPG. Elective adhesiolysis for chronic abdominal pain reduces long-term risk of adhesive small bowel obstruction. World J Emerg Surg. 2023 Jan 23;18(1):8. doi: 10.1186/s13017-023-00477-9.

    PMID: 36691000DERIVED

  • 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.

    PMID: 27074725DERIVED

  • 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.

    PMID: 26767310DERIVED

  • 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.

    PMID: 26338109DERIVED

  • 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.

    PMID: 26163959DERIVED

  • 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.

    PMID: 24723023DERIVED

Related Links

MeSH Terms

Conditions

Tissue Adhesions

Condition Hierarchy (Ancestors)

CicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Harry van Goor, MD, PhD, FRCS

    Radboud University Nijmegen Medical Center

    STUDY DIRECTOR

  • Richard PG ten Broek, BsC

    Radboud University Nijmegen Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2010

First Posted

November 8, 2010

Study Start

June 1, 2008

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

November 2, 2012

Record last verified: 2010-09

Locations

NL(1)