Barbed Suture for Emergency Midline Laparotomy Closure

NCT05351970 | Completed DMC

• 1 other identifier: BAROTOMY
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Incisional Hernia of Midline of Abdomen

Keywords

incisional hernia; midline laparotomy; urgency laparotomy; barbed suture; monofilament suture

Outcome Measures

Primary Outcomes (2)

• Incisional Hernia 1 month

  Incidence of incisional hernia at one month after surgery

  Hernia 1 month

• Incisional Hernia 1 year

  Incidence of incisional hernia at one year after surgery

  Hernia 1 year

Secondary Outcomes (3)

• Surgical Site Infection

  1 month

• Evisceration

  1 month

• Medical complications

  1 month

Study Arms (2)

Monofilament closure

Patients with midline emergency laparotomy, which closure was performed with monofilament suture

Barbed closure

Patients with midline emergency laparotomy, which closure was performed with barbed suture

Procedure: Barbed

Interventions

Barbed PROCEDURE

Efficacy of barbed and monofilament closure regarding incisional hernia

Barbed closure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with emergency laparotomy performed due to digestive surgical disease.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana: lead

Study Sites (1)

Hospital General Universitario de Elche

Elche, Alicante, 03203, Spain

Location

Related Publications (15)

• 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.

  PMID: 24035074 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 20395846 BACKGROUND

• 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.

  PMID: 25618025 BACKGROUND

• 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.

  PMID: 33677649 BACKGROUND

• 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.

  PMID: 33820730 BACKGROUND

• 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.

  PMID: 22445426 BACKGROUND

• 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.

  PMID: 32188284 BACKGROUND

• 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.

  PMID: 28254112 BACKGROUND

• 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.

  PMID: 10575560 BACKGROUND

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

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 32113031 BACKGROUND

• 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.

  PMID: 31183792 BACKGROUND

• 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.

  PMID: 22647387 BACKGROUND

Related Links

• Johnson-Johnson catalogue

MeSH Terms

Conditions

Incisional Hernia

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor Luis Sánchez-Guillén

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: April 28, 2022
• Study Start: January 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: June 15, 2023
• Last Updated: April 23, 2024

Record last verified: 2024-04

Locations

ES (1)