The Efficacy and Security of the Small Stitch Technique in Emergency Surgery

NCT03765060 | Unknown

• 1 other identifier: SL-Stitch
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the abdominal closure technique in emergency surgery. Half of participants will be perform the classic Large Stitch technique, while the other half will undergo the Small Stitch technique.

Conditions

Abdominal Wall Defect; Abdominal Wall Hernia; Eventration; Evisceration; Operation Wound

Outcome Measures

Primary Outcomes (1)

• Efficacy of the small stitch technique defined by eventration rate

  To determine the efficacy of the "Small stitch" technique versus the "Large Stitch" technique in the closure of midline laparotomy with respect to the production of eventration in patients undergoing urgent abdominal surgery.

  1 year

Secondary Outcomes (4)

• Efficacy of the small stitch technique defined by local complications rate

  1 year

• Efficacy of the small stitch technique defined by evisceration rate

  1 year

• Efficacy of the small stitch technique defined by improvement of quality of life

  1 year

• Security of the small stitch technique

  1 year

Study Arms (2)

Small Stitch

EXPERIMENTAL

Patients requiring an urgent emergency laparotomy. The Small Stitch closure technique will be perform using a Monomax® 2/0 HR26 (Half-circle Round body): * It will be use a very long-term monofilament absorbable synthetic suture of Poly-4-hydroxybutyrate (Monomax) 2/0 with HR 26 needle (Half-circle Round body). * In the technique should be given at least 2 points for each wound cm, with a distance to the alba line of 0'5cm and 0'5 cm of separation between stitches. The closure starts from both ends, ending in the middle of the laparotomy with an overlap of at least 2 cm. The ratio between the length of the suture and the length of the wound should be at least 4:1.

Procedure: Monomax® 2/0 HR26

Large Stitch

ACTIVE COMPARATOR

The intervention will be the classic large Stitch closure technique using a Monomax® 1 HR48 (Half-circle Round body). * It will be use a very long-term monofilament absorbable synthetic suture of Poly-4-hydroxybutyrate (Monomax) 1 with HR 48 needle (Half-circle Round body). * In the technique should be given 1 point for each wound cm, with a distance to the alba line of 1 cm and 1 cm of separation between stitches. The closure starts from both ends, ending in the middle of the laparotomy with an overlap of at least 2 cm. The ratio between the length of the suture and the length of the wound should be at least 4:1.

Procedure: Monomax® 1 HR48

Interventions

Monomax® 2/0 HR26 PROCEDURE

It will be use a very long-term monofilament absorbable synthetic suture of Poly-4-hydroxybutyrate (Monomax) 2/0 with HR 26 needle. In the technique should be given at least 2 points for each wound cm, with a distance to the alba line of 0'5cm and 0'5 cm of separation between stitches. The closure starts from both ends, ending in the middle of the laparotomy with an overlap of at least 2 cm. The ratio between the length of the suture and the length of the wound should be at least 4:1.

Also known as: Suture

Small Stitch

Monomax® 1 HR48 PROCEDURE

It will be use a very long-term monofilament absorbable synthetic suture of Poly-4-hydroxybutyrate (Monomax) 1 with HR 48 needle. In the technique should be given 1 point for each wound cm, with a distance to the alba line of 1 cm and 1 cm of separation between stitches. The closure starts from both ends, ending in the middle of the laparotomy with an overlap of at least 2 cm. The ratio between the length of the suture and the length of the wound should be at least 4:1.

Also known as: Suture

Large Stitch

Eligibility Criteria

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

You may qualify if:

• Patients over 18 years of age and who provide informed consent to participate in the study.
• Patients requiring an urgent midline laparotomy with a minimum size of 8 cm.

You may not qualify if:

• Prior midline laparotomy.
• Patients with BMI\> 45 kg / m2
• Patients with ASA (American Society of Anesthesiologists)\> IV.
• Patient with an advanced terminal illness with an expectation of life \<1 year.
• Patients with abdominal aortic aneurysm.
• Patients with coagulopathy: patient previously diagnosed with von Willebrand disease, hemophilia or Immune thrombocytopenic purpura.
• Immunosuppressed patient: HIV patients in the AIDS phase, chronic corticosteroid or immunosuppressive treatment.
• Patients with collagen pathology: patient previously diagnosed with Marfan syndrome, Ehlers-Danlos syndrome, homocystinuria and scleroderma.
• Chemotherapeutic treatment 2 weeks before surgery.
• Radiotherapy treatment 6 weeks before surgery.
• Diffuse peritonitis with hemodynamic instability, defined by non-response to fluids prior to surgery or during the surgical process.
• Pregnant or potentially fertile women, breastfeeding, or intention to become pregnant, or those who do not wish to use effective contraception (hormonal contraceptives (implantation, patches, oral), and double barrier methods (any double combination of: IUD (intrauterine device), male or female prophylactics with spermicidal gel, diaphragm, contraceptive sponge, cervical cap).

Sponsors & Collaborators

• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla: lead

Study Sites (1)

Hospital Universitario Virgen Del Rocio

Seville, 41013, Spain

RECRUITING

Related Publications (5)

• Israelsson LA, Millbourn D. Closing midline abdominal incisions. Langenbecks Arch Surg. 2012 Dec;397(8):1201-7. doi: 10.1007/s00423-012-1019-4. Epub 2012 Nov 11.

  PMID: 23143146 BACKGROUND

• Millbourn D, Cengiz Y, Israelsson LA. Risk factors for wound complications in midline abdominal incisions related to the size of stitches. Hernia. 2011 Jun;15(3):261-6. doi: 10.1007/s10029-010-0775-8. Epub 2011 Jan 30.

  PMID: 21279664 BACKGROUND

• Millbourn D, Wimo A, Israelsson LA. Cost analysis of the use of small stitches when closing midline abdominal incisions. Hernia. 2014;18(6):775-80. doi: 10.1007/s10029-013-1135-2. Epub 2013 Jul 10.

  PMID: 23839330 BACKGROUND

• O'Dwyer PJ, Courtney CA. Factors involved in abdominal wall closure and subsequent incisional hernia. Surgeon. 2003 Feb;1(1):17-22. doi: 10.1016/s1479-666x(03)80004-5.

  PMID: 15568420 BACKGROUND

• Israelsson LA, Jonsson T. Suture length to wound length ratio and healing of midline laparotomy incisions. Br J Surg. 1993 Oct;80(10):1284-6. doi: 10.1002/bjs.1800801020.

  PMID: 8242299 BACKGROUND

MeSH Terms

Conditions

Hernia, Abdominal; Gastroschisis

Interventions

Sutures

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies

Study Officials

• Tamayo López María Jesús, PhD

  Hospital Universitario Virgen del Rocio

  PRINCIPAL INVESTIGATOR

• Padillo Ruiz Francisco Javier, PhD

  Hospital Universitario Virgen del Rocio

  STUDY DIRECTOR

Central Study Contacts

Tamayo López María Jesús, PhD

CONTACT

686589986; mtamayolopez@gmail.com

Tallón Aguilar Luis, MD

CONTACT

653393951; ltallona@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2018
• First Posted: December 5, 2018
• Study Start: October 1, 2018
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: January 13, 2021

Record last verified: 2020-12

Locations

ES (1)