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Incisional Hernia of Midline of AbdomenBAROTOMYNCT05351970

Barbed Suture for Emergency Midline Laparotomy Closure

An observational study of Incisional Hernia of Midline of Abdomen, run by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana at 1 site in Spain.

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

Urgency surgeries are often performed in a stressful setting with critical patient involved. In this context, laparotomy closure can sometimes be the most neglected part of the procedure. Barbed sutures, frequently used in laparoscopic procedures, have proven to be effective in maintaining traction. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Incisional Hernia of Midline of Abdomen
What is being tested?
Barbed
Type of treatment
Surgery or procedure
How many people
128 participants
Where
1 siteSpain
Study dates
1 Jan 2021to 15 Jun 2023
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: Patients with emergency laparotomy performed due to digestive surgical disease.

Who may be able to join

  • Emergency laparotomy
  • Minimum age of 18 years old.
  • Digestive surgical disease.
  • Minimum survival of one month postoperatively.

Who cannot join

  • Laparoscopic surgical procedure.
  • Non-digestive surgical procedure (gynecology, urology...).

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital General Universitario de Elche

    Elche, Alicante, 03203

Other trials in Spain

About this study

Official title: Barbed Suture vs. Monofilament for Emergency Midline Laparotomy Closure, a Retrospective Analysis

Urgency surgeries are often performed in a stressful setting with critical patient involved. In this context, laparotomy closure can sometimes be the most neglected part of the procedure. Barbed sutures, frequently used in laparoscopic procedures, have proven to be effective in maintaining traction.

The aim of this study is to describe the incisional hernia rate after emergency midline laparotomy, according to the suture utilized, evaluated at one month and one year postoperative.

Read the detailed description

A retrospective cohort study was performed including patients with urgency midline laparotomy during 2018-2019. Group A was represented by patients with slowly absorbable monofilament continuous suture, while Group B included patients with barbed suture closure.

Main variables were hernia rates one month and one year after surgery, diagnosed by physical exploration and/or imaging. Demographic characteristics, risk factors, among other descriptive determinations were registered.

A total of 128 patients were performed an emergency midline laparotomies, and 110 meet all inclusion criteria. There was equality between sex and median age was 65 years old. Significative differences were observed regarding incisional hernia at 30 days, being less frequent when barbed suture was utilized. These differences were not present at the long-term reevaluation (one year).

In conclusion, midline laparotomy closure must be performed within quality standards. The lack of studies regarding emergency laparotomy closure, the European Hernia Society stated that no recommendations can be given on this patients. Barbed suture appears as a promising option for closure in these specific circumstances, but needs further study.

Being tested
Barbed
Keywords
incisional hernia, midline laparotomy, urgency laparotomy, barbed suture, monofilament suture
Medical subject headings
Incisional Hernia

What participants receive

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

  • BarbedProcedure or surgery

    Efficacy of barbed and monofilament closure regarding incisional hernia

Study groups in NCT05351970
Study groupRoleWhat they receive
Monofilament closurePatients with midline emergency laparotomy, which closure was performed with monofilament suture
Barbed closurePatients with midline emergency laparotomy, which closure was performed with barbed suture
Receives: Procedure: Barbed

What is being measured

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

  1. Incisional Hernia 1 month

    Incidence of incisional hernia at one month after surgery

    Measured: Hernia 1 month

  2. Incisional Hernia 1 year

    Incidence of incisional hernia at one year after surgery

    Measured: Hernia 1 year

Secondary outcomes (3)

  1. Surgical Site Infection

    Incidence of postoperative surgical site infection

    Measured: 1 month

  2. Evisceration

    Incidence of early abdominal evisceration

    Measured: 1 month

  3. Medical complications

    Incidence of other medical complications

    Measured: 1 month

Timeline

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

  1. First posted28 Apr 2022
  2. Study start1 Jan 2021
  3. Primary completion31 Dec 2022
  4. Study completion15 Jun 2023

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
Retrospective
Enrolment
128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05351970
Sponsor's protocol ID
BAROTOMY
Acronym
BAROTOMY
Status last verified
Apr 2024
First submitted
18 Apr 2022
Last updated
23 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Israelsson LA, Millbourn D. Prevention of incisional hernias: how to close a midline incision. Surg Clin North Am. 2013 Oct;93(5):1027-40. doi: 10.1016/j.suc.2013.06.009.

    PubMed 24035074

  • NELA (National Emergency Laparotomy Audit). Seventh Patient Report of the National Emergency Laparotomy Audit. December 2019 - November 2020.

  • Diener MK, Voss S, Jensen K, Buchler MW, Seiler CM. Elective midline laparotomy closure: the INLINE systematic review and meta-analysis. Ann Surg. 2010 May;251(5):843-56. doi: 10.1097/SLA.0b013e3181d973e4.

    PubMed 20395846

  • Muysoms FE, Antoniou SA, Bury K, Campanelli G, Conze J, Cuccurullo D, de Beaux AC, Deerenberg EB, East B, Fortelny RH, Gillion JF, Henriksen NA, Israelsson L, Jairam A, Janes A, Jeekel J, Lopez-Cano M, Miserez M, Morales-Conde S, Sanders DL, Simons MP, Smietanski M, Venclauskas L, Berrevoet F; European Hernia Society. European Hernia Society guidelines on the closure of abdominal wall incisions. Hernia. 2015 Feb;19(1):1-24. doi: 10.1007/s10029-014-1342-5. Epub 2015 Jan 25.

    PubMed 25618025

  • Peden CJ, Aggarwal G, Aitken RJ, Anderson ID, Bang Foss N, Cooper Z, Dhesi JK, French WB, Grant MC, Hammarqvist F, Hare SP, Havens JM, Holena DN, Hubner M, Kim JS, Lees NP, Ljungqvist O, Lobo DN, Mohseni S, Ordonez CA, Quiney N, Urman RD, Wick E, Wu CL, Young-Fadok T, Scott M. Guidelines for Perioperative Care for Emergency Laparotomy Enhanced Recovery After Surgery (ERAS) Society Recommendations: Part 1-Preoperative: Diagnosis, Rapid Assessment and Optimization. World J Surg. 2021 May;45(5):1272-1290. doi: 10.1007/s00268-021-05994-9. Epub 2021 Mar 6.

    PubMed 33677649

  • Velotti N, Manigrasso M, Di Lauro K, Vertaldi S, Anoldo P, Vitiello A, Milone F, Musella M, De Palma GD, Milone M. Barbed suture in gastro-intestinal surgery: A review with a meta-analysis. Surgeon. 2022 Apr;20(2):115-122. doi: 10.1016/j.surge.2021.02.011. Epub 2021 Apr 2.

    PubMed 33820730

  • Angioli R, Plotti F, Montera R, Damiani P, Terranova C, Oronzi I, Luvero D, Scaletta G, Muzii L, Panici PB. A new type of absorbable barbed suture for use in laparoscopic myomectomy. Int J Gynaecol Obstet. 2012 Jun;117(3):220-3. doi: 10.1016/j.ijgo.2011.12.023. Epub 2012 Mar 23.

    PubMed 22445426

  • Sundaram K, Piuzzi NS, Klika AK, Molloy RM, Higuera-Rueda CA, Krebs VE, Mont MA. Barbed sutures reduce arthrotomy closure duration and suture utilisation compared to interrupted conventional sutures for primary total hip arthroplasty: a randomised controlled trial. Hip Int. 2021 Sep;31(5):582-588. doi: 10.1177/1120700020911891. Epub 2020 Mar 19.

    PubMed 32188284

  • Lin YF, Lai SK, Liu QY, Liao BH, Huang J, Du L, Wang KJ, Li H. Efficacy and safety of barbed suture in minimally invasive radical prostatectomy: A systematic review and meta-analysis. Kaohsiung J Med Sci. 2017 Mar;33(3):107-115. doi: 10.1016/j.kjms.2016.12.005. Epub 2017 Jan 27.

    PubMed 28254112

  • Mingoli A, Puggioni A, Sgarzini G, Luciani G, Corzani F, Ciccarone F, Baldassarre E, Modini C. Incidence of incisional hernia following emergency abdominal surgery. Ital J Gastroenterol Hepatol. 1999 Aug-Sep;31(6):449-53.

    PubMed 10575560

  • National Healthcare Safety Network (NHSN). Surgical Site Infection. Jan 2022;39,11.

  • Morales S, Barreriro F, Hernández P, Feliu X. Cirugía de la pared abdominal. Asocación Española de Cirujanos; 2º Ed; Madrid; 2013: Sección III y VI.

  • Ruiz-Tovar J, Llavero C, Jimenez-Fuertes M, Duran M, Perez-Lopez M, Garcia-Marin A. Incisional Surgical Site Infection after Abdominal Fascial Closure with Triclosan-Coated Barbed Suture vs Triclosan-Coated Polydioxanone Loop Suture vs Polydioxanone Loop Suture in Emergent Abdominal Surgery: A Randomized Clinical Trial. J Am Coll Surg. 2020 May;230(5):766-774. doi: 10.1016/j.jamcollsurg.2020.02.031. Epub 2020 Feb 27.

    PubMed 32113031

  • Clapp B, Klingsporn W, Lodeiro C, Wicker E, Christensen L, Jones R, Tyroch A. Small bowel obstructions following the use of barbed suture: a review of the literature and analysis of the MAUDE database. Surg Endosc. 2020 Mar;34(3):1261-1269. doi: 10.1007/s00464-019-06890-z. Epub 2019 Jun 10.

    PubMed 31183792

  • Rahbari NN, Knebel P, Kieser M, Bruckner T, Bartsch DK, Friess H, Mihaljevic AL, Stern J, Diener MK, Voss S, Rossion I, Buchler MW, Seiler CM. Design and current status of CONTINT: continuous versus interrupted abdominal wall closure after emergency midline laparotomy - a randomized controlled multicenter trial [NCT00544583]. Trials. 2012 May 30;13:72. doi: 10.1186/1745-6215-13-72.

    PubMed 22647387

Questions about this trial

What is this clinical trial studying?

An observational study of Incisional Hernia of Midline of Abdomen, run by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana at 1 site in Spain.

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 4 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 23 Apr 2024. 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 Spain. 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?

Incisional Hernia 1 month (time frame: Hernia 1 month). The study lists 2 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 NCT05351970, which also lists 15 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 23 Apr 2024.

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