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Tissue AdhesionsLAPADNCT01236625

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

An observational study of Tissue Adhesions, run by Radboud University Medical Center at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tissue Adhesions
What is being tested?
Adhesiolysis
Type of treatment
Surgery or procedure
How many people
752 participants
Where
1 siteNetherlands
Study dates
Jun 2008to Feb 2011
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • Operation cancelled
  • Bad quality of data

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Radboud University Nijmegen Medical Center

    Nijmegen, Gelderland, 6500HB

Other trials in Netherlands

About this study

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

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

Read more

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

Being tested
Adhesiolysis
Keywords
Tissue Adhesions, Adhesiolysis, Inadvertent enterotomy, Prospective cohort study, Quality of life
Medical subject headings
Tissue Adhesions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AdhesiolysisProcedure or surgery

    Blunt or sharp dissection of adhesive tissue.

Study groups in NCT01236625
Study groupRoleWhat they receive
No adhesiolysisAll patient undergoing elective laparotomy or laparoscopy with no need for adhesiolysis during the procedure.
AdhesiolysisAll patient undergoing elective laparotomy or laparoscopy requiring adhesiolysis during the procedure.
Receives: Procedure: Adhesiolysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Inadvertent Enterotomy

    Every unintended and iatrogenic full thickness defect of the bowel.

    Measured: Day of surgery (one day)

  2. Seromuscular Injury

    Every visible damage to the serosa, without leakage or exposure of the bowel lumen.

    Measured: Day of surgery (one day)

  3. Miscellaneous Organ Damage

    Unintended iatrogenic damage to intra- peritoneal organs and structures other than bowel. E.g. Spleen, liver, pancreas or ureter.

    Measured: Day of surgery (one day)

  4. 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

    Measured: 30 days

  5. Adhesiolysis Time

    Time required to dissect adhesive tissue.

    Measured: Day of surgery (one day)

Secondary outcomes (6)

  1. Hospital stay

    Number of days from surgery until discharge

    Measured: From surgery to discharge

  2. Reinterventions

    Emergency reoperation related to a complication of initial surgery within max. 30 days after discharge.

    Measured: 30 days after discharge

  3. In- hospital Costs

    Direct costs comprising costs from operation, stay on ward and Intesive Care Unit, medication use, diagnostics.

    Measured: From surgery to discharge

  4. Parenteral Feeding

    Number of days that patient required parenteral feeding.

    Measured: From surgery to discharge

  5. Short term readmissions

    Readmissions to the hospital related to complication of surgery.

    Measured: 30 days after discharge

  6. Quality of life

    Quality of life as measured with SF-36, Gastro- intestinal tract complaints and DASI index.

    Measured: 6 months post surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2010 (estimated)
  2. Study startJun 2008
  3. Primary completionFeb 2011
  4. Study completionFeb 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
752 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01236625
Sponsor's protocol ID
RU-RTB-0003
Acronym
LAPAD
Status last verified
Sep 2010
First submitted
4 Nov 2010
Last updated
2 Nov 2012
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 17824967

  • 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.

    PubMed 10759744

  • 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.

    PubMed 11391142

  • 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.

    PubMed 38000068

  • 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.

    PubMed 36691000

  • 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.

    PubMed 27074725

  • 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.

    PubMed 26767310

  • 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.

    PubMed 26338109

  • 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.

    PubMed 26163959

  • 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.

    PubMed 24723023

Questions about this trial

What is this clinical trial studying?

An observational study of Tissue Adhesions, run by Radboud University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Inadvertent Enterotomy (time frame: Day of surgery (one day)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01236625, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2012.

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