Influence of Suture Type on Emergency Midline Laparotomy Closure

NCT06865807 | Recruiting

• 1 other identifier: 52/24
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

There is no clear recommendation in international guidelines regarding the type of suture to be used for closing emergency midline laparotomies. It is recommended to follow the same principles as in elective surgery, thus performing the closure with a continuous suture of slowly absorbable monofilament 2-0 with small-bites technique. Currently, there are several slowly absorbable sutures available on the market, and our center uses two: PDS® and Monomax®. These two sutures are currently used interchangeably at our institution based on the preferences of each surgeon. Objective: study whether there are differences between these two sutures in the closure of emergency midline laparotomy.

Conditions

Linea Alba Hernia; Evisceration; Operation Wound; Suture; Complications, Mechanical

Outcome Measures

Primary Outcomes (1)

• Evisceration

  Rate of evisceration

  1 month

Secondary Outcomes (2)

• Wound complication

  1 month

• Incisional hernia

  1 year

Study Arms (2)

PDS

ACTIVE COMPARATOR

Closure emergency laparotomy using PDS 2/0 small bites

Procedure: PDS 2/0 vs Monomax 2/0

Monomax

EXPERIMENTAL

Closure emergency laparotomy using Monomax 2/0 small bites

Procedure: PDS 2/0 vs Monomax 2/0

Interventions

PDS 2/0 vs Monomax 2/0 PROCEDURE

We will include in the study patients who require an emergency midline laparotomy by the General and Digestive Surgery Department of the University Hospital Nuestra Señora de Candelaria. Patients will be randomized based on their medical record number: those with an even number will undergo laparotomy closure using PDS 2/0, and those with an odd number will receive Monomax 2/0.

Monomax; PDS

Eligibility Criteria

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

You may qualify if:

• \>18 years old, patients undergoing emergency midline laparotomy by the General Surgery Department.

You may not qualify if:

• \<18 years old, previous midline laparotomy

Sponsors & Collaborators

• Hospital San Juan de Dios Tenerife: lead

Study Sites (1)

University Hospital Nuestra Señora de Candelaria

Santa Cruz de Tenerife, Spain

RECRUITING

Related Publications (4)

• Bosanquet DC, Ansell J, Abdelrahman T, Cornish J, Harries R, Stimpson A, Davies L, Glasbey JC, Frewer KA, Frewer NC, Russell D, Russell I, Torkington J. Systematic Review and Meta-Regression of Factors Affecting Midline Incisional Hernia Rates: Analysis of 14,618 Patients. PLoS One. 2015 Sep 21;10(9):e0138745. doi: 10.1371/journal.pone.0138745. eCollection 2015.

  PMID: 26389785 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

• Frassini S, Cobianchi L, Fugazzola P, Biffl WL, Coccolini F, Damaskos D, Moore EE, Kluger Y, Ceresoli M, Coimbra R, Davies J, Kirkpatrick A, Di Carlo I, Hardcastle TC, Isik A, Chiarugi M, Gurusamy K, Maier RV, Segovia Lohse HA, Jeekel H, Boermeester MA, Abu-Zidan F, Inaba K, Weber DG, Augustin G, Bonavina L, Velmahos G, Sartelli M, Di Saverio S, Ten Broek RPG, Granieri S, Dal Mas F, Fare CN, Peverada J, Zanghi S, Vigano J, Tomasoni M, Dominioni T, Cicuttin E, Hecker A, Tebala GD, Galante JM, Wani I, Khokha V, Sugrue M, Scalea TM, Tan E, Malangoni MA, Pararas N, Podda M, De Simone B, Ivatury R, Cui Y, Kashuk J, Peitzman A, Kim F, Pikoulis E, Sganga G, Chiara O, Kelly MD, Marzi I, Picetti E, Agnoletti V, De'Angelis N, Campanelli G, de Moya M, Litvin A, Martinez-Perez A, Sall I, Rizoli S, Tomadze G, Sakakushev B, Stahel PF, Civil I, Shelat V, Costa D, Chichom-Mefire A, Latifi R, Chirica M, Amico F, Pardhan A, Seenarain V, Boyapati N, Hatz B, Ackermann T, Abeyasundara S, Fenton L, Plani F, Sarvepalli R, Rouhbakhshfar O, Caleo P, Ho-Ching Yau V, Clement K, Christou E, Castillo AMG, Gosal PKS, Balasubramaniam S, Hsu J, Banphawatanarak K, Pisano M, Adriana T, Michele A, Cioffi SPB, Spota A, Catena F, Ansaloni L. ECLAPTE: Effective Closure of LAParoTomy in Emergency-2023 World Society of Emergency Surgery guidelines for the closure of laparotomy in emergency settings. World J Emerg Surg. 2023 Jul 26;18(1):42. doi: 10.1186/s13017-023-00511-w.

  PMID: 37496068 BACKGROUND

• Thorup T, Tolstrup MB, Gogenur I. Reduced rate of incisional hernia after standardized fascial closure in emergency laparotomy. Hernia. 2019 Apr;23(2):341-346. doi: 10.1007/s10029-019-01893-0. Epub 2019 Jan 25.

  PMID: 30684103 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 10, 2025
• Study Start: February 10, 2025
• Primary Completion: February 10, 2026
• Study Completion (Estimated): December 10, 2026
• Last Updated: March 11, 2025

Record last verified: 2025-03

Locations

ES (1)