Influence of Suture Type on Emergency Midline Laparotomy Closure

NCT ID: NCT06865807

Last Updated: 2025-03-11

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-10

Study Completion Date

2026-12-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PDS

Closure emergency laparotomy using PDS 2/0 small bites

Group Type ACTIVE_COMPARATOR

PDS 2/0 vs Monomax 2/0

Intervention Type 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

Closure emergency laparotomy using Monomax 2/0 small bites

Group Type EXPERIMENTAL

PDS 2/0 vs Monomax 2/0

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PDS 2/0 vs Monomax 2/0

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* \<18 years old, previous midline laparotomy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospital San Juan de Dios Tenerife

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Julen Ramon Rodríguez

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital Nuestra Señora de Candelaria

Santa Cruz de Tenerife, , Spain

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Spain

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Julen Ramón, PhD

Role: primary

672255215

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 26389785 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25618025 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37496068 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30684103 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

52/24

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Short Stitch Monomax®
NCT01938222 COMPLETED