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

Primary Purpose

Abdominal Wall Defect, Abdominal Wall Hernia, Eventration

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Monomax® 2/0 HR26
Monomax® 1 HR48
Sponsored by
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Abdominal Wall Defect

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. Prior midline laparotomy.
  2. Patients with BMI> 45 kg / m2
  3. Patients with ASA (American Society of Anesthesiologists)> IV.
  4. Patient with an advanced terminal illness with an expectation of life <1 year.
  5. Patients with abdominal aortic aneurysm.
  6. Patients with coagulopathy: patient previously diagnosed with von Willebrand disease, hemophilia or Immune thrombocytopenic purpura.
  7. Immunosuppressed patient: HIV patients in the AIDS phase, chronic corticosteroid or immunosuppressive treatment.
  8. Patients with collagen pathology: patient previously diagnosed with Marfan syndrome, Ehlers-Danlos syndrome, homocystinuria and scleroderma.
  9. Chemotherapeutic treatment 2 weeks before surgery.
  10. Radiotherapy treatment 6 weeks before surgery.
  11. Diffuse peritonitis with hemodynamic instability, defined by non-response to fluids prior to surgery or during the surgical process.
  12. 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).

Sites / Locations

  • Hospital Universitario Virgen Del RocioRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Small Stitch

Large Stitch

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Efficacy of the small stitch technique defined by local complications rate
To determine whether the closure of midline laparotomy with the "Small Stitch" technique in patients undergoing urgent abdominal surgery reduces the local complications of the surgical wound defined by hematoma, seroma or wound infection.
Efficacy of the small stitch technique defined by evisceration rate
To determine if the closure of the midline laparotomy with the "Small Stitch" technique in patients undergoing urgent abdominal surgery reduces the rate of evisceration.
Efficacy of the small stitch technique defined by improvement of quality of life
To determine if the closure of a midline laparotomy with the "Small Stitch" technique in patients undergoing urgent abdominal surgery improves the quality of life.
Security of the small stitch technique
To determine the safety of the Small Stitch technique versus the "Large Stitch" technique in the closure of the midline laparotomy with respect to the incidence of adverse events and serious adverse events, the incidence of side effects related to the treatment and the incidence and the reasons for premature withdrawal of premature patient from the study.

Full Information

First Posted
August 8, 2018
Last Updated
January 12, 2021
Sponsor
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
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1. Study Identification

Unique Protocol Identification Number
NCT03765060
Brief Title
The Efficacy and Security of the Small Stitch Technique in Emergency Surgery
Acronym
STCU
Official Title
Clinical Trial on the Efficacy and Security of the Small Stitch Technique Versus the Large Stitch Closure Laparotomy Technique in Emergency Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
December 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The closure of laparotomy is one of the most important challenges facing the surgeon. The classic technique of wall closure is the Large Stitch technique that uses monofilament double-strand sutures with a SL/WL (Suture Lengh/Wound Lengh) 4:1 ratio, with a distance to the alba line and between each stitch of 1 cm. Nowadays, the Small Stitch technique is accepted as the technique of choice for closure of laparotomies in programmed surgery. It is based on a very long-term monofilament absorbable synthetic suture of Poly-4-hydroxybutyrate (Monomax) 2/0 with HR (Half-circle Round body) 26 needle. Stitches should be given with a distance to the alba line of 0'5cm and 0'5 cm of separation between stitches. There are very few studies about the role of Small Stitch technique in the field of Emergency Surgery where the increased morbidity of the patient and the higher rate of surgical wound infection can play a fundamental role, and could be improved with the use of new abdominal wall closure techniques.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Wall Defect, Abdominal Wall Hernia, Eventration, Evisceration; Operation Wound

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
105 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Small Stitch
Arm Type
Experimental
Arm Description
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.
Arm Title
Large Stitch
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Monomax® 2/0 HR26
Other Intervention Name(s)
Suture
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Monomax® 1 HR48
Other Intervention Name(s)
Suture
Intervention Description
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.
Primary Outcome Measure Information:
Title
Efficacy of the small stitch technique defined by eventration rate
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Efficacy of the small stitch technique defined by local complications rate
Description
To determine whether the closure of midline laparotomy with the "Small Stitch" technique in patients undergoing urgent abdominal surgery reduces the local complications of the surgical wound defined by hematoma, seroma or wound infection.
Time Frame
1 year
Title
Efficacy of the small stitch technique defined by evisceration rate
Description
To determine if the closure of the midline laparotomy with the "Small Stitch" technique in patients undergoing urgent abdominal surgery reduces the rate of evisceration.
Time Frame
1 year
Title
Efficacy of the small stitch technique defined by improvement of quality of life
Description
To determine if the closure of a midline laparotomy with the "Small Stitch" technique in patients undergoing urgent abdominal surgery improves the quality of life.
Time Frame
1 year
Title
Security of the small stitch technique
Description
To determine the safety of the Small Stitch technique versus the "Large Stitch" technique in the closure of the midline laparotomy with respect to the incidence of adverse events and serious adverse events, the incidence of side effects related to the treatment and the incidence and the reasons for premature withdrawal of premature patient from the study.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tamayo López María Jesús, PhD
Phone
686589986
Email
mtamayolopez@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tallón Aguilar Luis, MD
Phone
653393951
Email
ltallona@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tamayo López María Jesús, PhD
Organizational Affiliation
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Padillo Ruiz Francisco Javier, PhD
Organizational Affiliation
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Universitario Virgen Del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mª Jesús Tamayo lópez, PhD
Phone
34955013414
Email
mtamayolopez@gmail.com
First Name & Middle Initial & Last Name & Degree
Luis Tallón Aguilar
Email
ltallona@hotmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
23143146
Citation
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.
Results Reference
background
PubMed Identifier
21279664
Citation
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.
Results Reference
background
PubMed Identifier
23839330
Citation
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.
Results Reference
background
PubMed Identifier
15568420
Citation
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.
Results Reference
background
PubMed Identifier
8242299
Citation
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.
Results Reference
background

Learn more about this trial

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

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