NCT00761475

Brief Summary

Incisional hernia is the most frequently seen long term complication in surgery causing much morbidity and even mortality in patients. Despite studies on the optimal closing technique for laparotomies, the risk for incisional hernia after midline incision remains about 5-20 %. Major risk factors for incisional hernia after a laparotomy, like obesity, steroid use, malnutrition, smoking and connective tissue disorders, are known. Despite this knowledge, there has not yet been developed a sufficient method for prevention. One specific group of high risk patients are patients with an abdominal aortic aneurysm (AAA). The relationship between aortic aneurysm and other abdominal wall hernias, like inguinal hernias, has been reported. Retrospective and prospective studies have shown an average risk for incisional hernia after AAA repair of 31.6 %. Another high risk group is the group of obese patients. Patients with a BMI of more than 27 have a high risk of developing an incisional hernia after midline incision with an incidence of 22% after 12 months. Considering only 50 % of incisional hernia will be clinically evident in the first 12 months, the total incidence will be above 30%. This high risk group of patients with obesitas and aneurysmatic disease can benefit most from prevention. Some small studies have been performed to evaluate the usefulness and safety of primary laparotomy wound closure with the aid of prosthetic mesh. These studies show a very low risk for incisional hernias and a low infection rate, even when used in contaminated wounds such as colostomal surgery. However, there has not been performed an adequate randomized controlled trial to study the prevention of incisional hernias. Our hypothesis is that incisional hernia prevention with use of prosthetic mesh after laparotomy is effective in patients with aortic aneurysm and in obese patients with a BMI of more than 27.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
480

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2009

Longer than P75 for phase_3

Geographic Reach
3 countries

12 active sites

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

First Submitted

Initial submission to the registry

September 26, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 29, 2008

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

October 28, 2016

Status Verified

October 1, 2016

Enrollment Period

3.8 years

First QC Date

September 26, 2008

Last Update Submit

October 27, 2016

Conditions

Incisional Hernia Occurence

Keywords

incisional hernia

Outcome Measures

Primary Outcomes (1)

  • incisional hernia occurence

    2 years

Secondary Outcomes (3)

  • complications

    1 month

  • post-operative pain

    1 month

  • quality of life

    2 years

Study Arms (3)

1

PLACEBO COMPARATOR

primary closure of the midline

Procedure: primary closure

2

ACTIVE COMPARATOR

onlay mesh supported closure

Procedure: mesh supported closure

3

ACTIVE COMPARATOR

sublay mesh supported closure

Procedure: mesh supported closure

Interventions

mesh supported closurePROCEDURE

onlay mesh supported closure midline laparotomy

2
primary closurePROCEDURE

primary closure of the midline

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Every elective midline laparotomy for patients with Abdominal Aortic Aneurysm and patients with a BMI of more than 27.
  • Signed informed consent

You may not qualify if:

  • Age \< 18 years
  • Emergency procedure
  • Aortic reconstruction for obstructive disease
  • Life expectancy less than 24 months
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Wilhelminenspital

Vienna, Austria

Location

Berlin-Charite Universitatsklinikum

Berlin, Germany

Location

Hamburg-Eppefdorf Universitatsklinikum

Hamburg, Germany

Location

Heidelberg University Medical Center

Heidelberg, Germany

Location

Munchen University Medical Center

München, Germany

Location

Erasmus Medical Center

Rotterdam, South Holland, 3015 CE, Netherlands

Location

IJsselland Ziekenhuis

Capelle aan den IJssel, Netherlands

Location

Scheper Ziekenhuis

Emmen, Netherlands

Location

Maasstad Ziekenhuis

Rotterdam, Netherlands

Location

Sint Franciscus Gasthuis

Rotterdam, Netherlands

Location

Maxima Medisch Centrum

Veldhoven, Netherlands

Location

Isala klinieken

Zwolle, Netherlands

Location

Related Publications (4)

  • Van den Dop LM, Sneiders D, Yurtkap Y, Werba A, van Klaveren D, Pierik REGJM, Reim D, Timmermans L, Fortelny RH, Mihaljevic AL, Kleinrensink GJ, Tanis PJ, Lange JF, Jeekel J; PRIMA Trialist Group. Prevention of incisional hernia with prophylactic onlay and sublay mesh reinforcement vs. primary suture only in midline laparotomies (PRIMA): long-term outcomes of a multicentre, double-blind, randomised controlled trial. Lancet Reg Health Eur. 2023 Nov 22;36:100787. doi: 10.1016/j.lanepe.2023.100787. eCollection 2024 Jan.

    PMID: 38188275DERIVED

  • Jairam AP, Timmermans L, Eker HH, Pierik REGJM, van Klaveren D, Steyerberg EW, Timman R, van der Ham AC, Dawson I, Charbon JA, Schuhmacher C, Mihaljevic A, Izbicki JR, Fikatas P, Knebel P, Fortelny RH, Kleinrensink GJ, Lange JF, Jeekel HJ; PRIMA Trialist Group. Prevention of incisional hernia with prophylactic onlay and sublay mesh reinforcement versus primary suture only in midline laparotomies (PRIMA): 2-year follow-up of a multicentre, double-blind, randomised controlled trial. Lancet. 2017 Aug 5;390(10094):567-576. doi: 10.1016/S0140-6736(17)31332-6. Epub 2017 Jun 20.

    PMID: 28641875DERIVED

  • Timmermans L, Eker HH, Steyerberg EW, Jairam A, de Jong D, Pierik EG, Lases SS, van der Ham AC, Dawson I, Charbon J, Schuhmacher C, Izbicki JR, Neuhaus P, Knebel P, Fortelny R, Kleinrensink GJ, Jeekel J, Lange JF. Short-term results of a randomized controlled trial comparing primary suture with primary glued mesh augmentation to prevent incisional hernia. Ann Surg. 2015 Feb;261(2):276-81. doi: 10.1097/SLA.0000000000000798.

    PMID: 24983993DERIVED

  • Nieuwenhuizen J, Eker HH, Timmermans L, Hop WC, Kleinrensink GJ, Jeekel J, Lange JF; PRIMA Trialist Group. A double blind randomized controlled trial comparing primary suture closure with mesh augmented closure to reduce incisional hernia incidence. BMC Surg. 2013 Oct 28;13:48. doi: 10.1186/1471-2482-13-48.

    PMID: 24499111DERIVED

MeSH Terms

Conditions

Incisional Hernia

Condition Hierarchy (Ancestors)

HerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Study Officials

  • J.F. Lange, Professor

    Erasmus Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. J.F. Lange

Study Record Dates

First Submitted

September 26, 2008

First Posted

September 29, 2008

Study Start

February 1, 2009

Primary Completion

December 1, 2012

Study Completion

April 1, 2015

Last Updated

October 28, 2016

Record last verified: 2016-10

Locations

AU(1)NL(7)DE(4)