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Trial record 26 of 31 for:    "Gastroschisis"

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

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ClinicalTrials.gov Identifier: NCT03765060
Recruitment Status : Recruiting
First Posted : December 5, 2018
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

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.

Condition or disease Intervention/treatment Phase
Abdominal Wall Defect Abdominal Wall Hernia Eventration Evisceration; Operation Wound Procedure: Monomax® 2/0 HR26 Procedure: Monomax® 1 HR48 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Clinical Trial on the Efficacy and Security of the Small Stitch Technique Versus the Large Stitch Closure Laparotomy Technique in Emergency Surgery
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Small Stitch

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

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.

Other Name: Suture

Active Comparator: Large Stitch

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

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.

Other Name: Suture




Primary Outcome Measures :
  1. Efficacy of the small stitch technique defined by eventration rate [ Time Frame: 1 year ]
    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 :
  1. Efficacy of the small stitch technique defined by local complications rate [ Time Frame: 1 year ]
    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.

  2. Efficacy of the small stitch technique defined by evisceration rate [ Time Frame: 1 year ]
    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.

  3. Efficacy of the small stitch technique defined by improvement of quality of life [ Time Frame: 1 year ]
    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.

  4. Security of the small stitch technique [ Time Frame: 1 year ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03765060


Contacts
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Contact: Tamayo López María Jesús, PhD 686589986 mtamayolopez@gmail.com
Contact: Tallón Aguilar Luis, MD 653393951 ltallona@hotmail.com

Locations
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Spain
Hospital Universitario Virgen Del Rocio Recruiting
Sevilla, Spain, 41013
Contact: Mª Jesús Tamayo lópez, PhD    34955013414    mtamayolopez@gmail.com   
Contact: Luis Tallón Aguilar       ltallona@hotmail.com   
Sponsors and Collaborators
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Investigators
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Principal Investigator: Tamayo López María Jesús, PhD HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO
Study Director: Padillo Ruiz Francisco Javier, PhD HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO

Publications:
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Responsible Party: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
ClinicalTrials.gov Identifier: NCT03765060     History of Changes
Other Study ID Numbers: SL-Stitch
First Posted: December 5, 2018    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Emergencies
Hernia, Ventral
Disease Attributes
Pathologic Processes
Hernia, Abdominal
Hernia
Pathological Conditions, Anatomical
Sodium Oxybate
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs