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Primary Mesh Closure of Abdominal Midline Wounds

NCT ID: NCT00761475

Last Updated: 2016-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

480 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2015-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Incisional Hernia Occurence

Keywords

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incisional hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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1

primary closure of the midline

Group Type PLACEBO_COMPARATOR

primary closure

Intervention Type PROCEDURE

primary closure of the midline

2

onlay mesh supported closure

Group Type ACTIVE_COMPARATOR

mesh supported closure

Intervention Type PROCEDURE

onlay mesh supported closure midline laparotomy

3

sublay mesh supported closure

Group Type ACTIVE_COMPARATOR

mesh supported closure

Intervention Type PROCEDURE

sublay mesh supported closure midline laparotomy

Interventions

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mesh supported closure

onlay mesh supported closure midline laparotomy

Intervention Type PROCEDURE

primary closure

primary closure of the midline

Intervention Type PROCEDURE

mesh supported closure

sublay mesh supported closure midline laparotomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Age \< 18 years
* Emergency procedure
* Inclusion in other trials
* Aortic reconstruction for obstructive disease
* Life expectancy less than 24 months
* Pregnant women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baxter Healthcare Corporation

INDUSTRY

Sponsor Role collaborator

Aesculap AG

INDUSTRY

Sponsor Role collaborator

Erasmus Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Hasan Eker

Prof. Dr. J.F. Lange

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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J.F. Lange, Professor

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Locations

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Wilhelminenspital

Vienna, , Austria

Site Status

Berlin-Charite Universitatsklinikum

Berlin, , Germany

Site Status

Hamburg-Eppefdorf Universitatsklinikum

Hamburg, , Germany

Site Status

Heidelberg University Medical Center

Heidelberg, , Germany

Site Status

Munchen University Medical Center

München, , Germany

Site Status

Erasmus Medical Center

Rotterdam, South Holland, Netherlands

Site Status

IJsselland Ziekenhuis

Capelle aan den IJssel, , Netherlands

Site Status

Scheper Ziekenhuis

Emmen, , Netherlands

Site Status

Maasstad Ziekenhuis

Rotterdam, , Netherlands

Site Status

Sint Franciscus Gasthuis

Rotterdam, , Netherlands

Site Status

Maxima Medisch Centrum

Veldhoven, , Netherlands

Site Status

Isala klinieken

Zwolle, , Netherlands

Site Status

Countries

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Austria Germany Netherlands

References

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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.

Reference Type DERIVED
PMID: 38188275 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28641875 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24983993 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24499111 (View on PubMed)

Other Identifiers

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PRIMA TRIAL

Identifier Type: -

Identifier Source: org_study_id