Your browser doesn't support javascript.
Protocol for a randomized controlled trial comparing wound COmplications in elective midline laparotomies after FAscia Closure using two different Techniques Of Running sutures: COFACTOR trial.
El Charif, Mohamad Hadi; Hassan, Zeina; Hoballah, Jamal; Khalife, Mohamad; Sbaity, Eman.
  • El Charif MH; Department of Surgery, American University of Beirut Medical Center, Riad El Solh, Beirut, 1107 2020, Lebanon.
  • Hassan Z; Department of Surgery, American University of Beirut Medical Center, Riad El Solh, Beirut, 1107 2020, Lebanon.
  • Hoballah J; Department of Surgery, American University of Beirut Medical Center, Riad El Solh, Beirut, 1107 2020, Lebanon.
  • Khalife M; Department of Surgery, American University of Beirut Medical Center, Riad El Solh, Beirut, 1107 2020, Lebanon.
  • Sbaity E; Department of Surgery, American University of Beirut Medical Center, Riad El Solh, Beirut, 1107 2020, Lebanon. es25@aub.edu.lb.
Trials ; 21(1): 608, 2020 Jul 02.
Artículo en Inglés | MEDLINE | ID: covidwho-621539
ABSTRACT

BACKGROUND:

Wound complications following midline laparotomies are common and the main source of postoperative morbidity including superficial or deep wound infection, skin dehiscence, fascia dehiscence, and incisional hernia. Abdominal closure complications are strongly associated with suture technique and material, in addition to other factors related to the patient and type of surgery performed. The traditional technique is to place the fascia sutures 1 cm apart and at least 1 cm away from the fascia edge. A Swedish study described a new technique of placing the sutures 5 mm apart and 5 mm away from the fascia edge, resulting in lower rates of abdominal wound complications. This study has a number of limitations. There is a need for improved quality evidence to convince the surgical community to change the closure technique of abdominal wounds aiming to reduce morbidity, which is exemplified in incisional hernias and other various postop complications.

METHODS:

This is a 11 randomized, controlled, patient- and assessor-blinded, parallel design, superiority trial, with a primary endpoint of incisional hernia at 1 year. The study will be conducted at AUBMC over a 3-year period. Patients planned for a non-emergent midline laparotomy for general surgery or vascular procedure will be randomized to either fascia closure technique. In order to detect a drop of 12% in the incidence of incisional hernia, with 80% power and an alpha of 0.05, we will need to recruit 114 patients per arm. After adjusting for loss to follow-up, target recruitment is 274 subjects. We will compare both arms for the primary, secondary, and exploratory outcomes, using chi-square or t test as appropriate. Univariate and multivariate logistic regression will be done.

DISCUSSION:

This trial will assess postop complications following abdominal midline wound closures via two different suturing techniques. This trial will generate evidence-based conclusions that will allow surgeons to assess the role of a new abdominal closure technique in decreasing short- and long-term postoperative complications, for a commonly performed procedure. TRIAL REGISTRATION ClinicalTrials.gov NCT03527433 . Registered on 17 May 2018 before starting participant enrollment.
Asunto(s)
Palabras clave

Texto completo: Disponible Colección: Bases de datos internacionales Base de datos: MEDLINE Asunto principal: Técnicas de Sutura / Hernia Abdominal / Técnicas de Cierre de Herida Abdominal / Hernia Incisional Tipo de estudio: Estudio de cohorte / Estudio experimental / Estudio observacional / Estudio pronóstico / Ensayo controlado aleatorizado Límite: Humanos País/Región como asunto: Asia Idioma: Inglés Revista: Trials Asunto de la revista: Medicina / Terapeutica Año: 2020 Tipo del documento: Artículo País de afiliación: S13063-020-04507-8

Similares

MEDLINE

...
LILACS

LIS


Texto completo: Disponible Colección: Bases de datos internacionales Base de datos: MEDLINE Asunto principal: Técnicas de Sutura / Hernia Abdominal / Técnicas de Cierre de Herida Abdominal / Hernia Incisional Tipo de estudio: Estudio de cohorte / Estudio experimental / Estudio observacional / Estudio pronóstico / Ensayo controlado aleatorizado Límite: Humanos País/Región como asunto: Asia Idioma: Inglés Revista: Trials Asunto de la revista: Medicina / Terapeutica Año: 2020 Tipo del documento: Artículo País de afiliación: S13063-020-04507-8