About: 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

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About: 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 Goto Sponge NotDistinct Permalink

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type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has title	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
Creator	Hassan, Zeina Hoballah, Jamal Khalife, Mohamad Sbaity, Eman Charif, El Hadi, Mohamad
Source	Medline; PMC
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 1:1 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.
has issue date	2020-07-02(xsd:dateTime)
bibo:doi	10.1186/s13063-020-04507-8
bibo:pmid	32616017
has license	cc-by
sha1sum (hex)	dfc23033f8954e3ecd2c7f84de272449b679b04e
schema:url	https://doi.org/10.1186/s13063-020-04507-8
resource representing a document's title	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
has PubMed Central identifier	PMC7330541
has PubMed identifier	32616017
schema:publication	Trials
resource representing a document's body	covid:dfc23033f8954e3ecd2c7f84de272449b679b04e#body_text
is schema:about of	named entity 'superiority' named entity 'loss' named entity 'drop' named entity 'procedure' named entity 'fascia' named entity 'conducted' named entity 'improved' named entity 'comparing' named entity 'randomized controlled trial' named entity 'performed' named entity 'multivariate' named entity 'arm' named entity 'recruit' named entity 'Closure' named entity 'infection' named entity 'sutures' named entity 'randomized controlled trial' named entity 'COFACTOR' named entity 'surgical resident' named entity 'physical examination' named entity 'obese' named entity 'colorectal cancer' named entity 'incisional hernia' named entity 'disability' named entity 'intra-observer variability' named entity 'incisional hernia' named entity 'SSI' named entity 'biostatistician' named entity 'Ultrasound' named entity 'suture' named entity 'physical examination' named entity 'incisional hernia' named entity 'dehiscence' named entity 'incisional hernia' named entity 'outpatient clinic' named entity 'incisional hernia' named entity 'ITT' named entity 'surgical site infection' named entity 'DMC' named entity 'abdominal viscera' named entity 'laparotomies' named entity 'incisional' named entity 'higher risk' named entity 'suture material' named entity 'risk factors' named entity 'biostatistician' named entity 'reoperation' named entity 'categorical variable' named entity 'morbidity' named entity 'adverse effects' named entity 'edema' named entity 'radiology department' named entity 'hernias' named entity 'wound infection' named entity 'odds ratio' named entity 'suture' named entity 'laparoscopic procedure' named entity 'Fascial' named entity 'suture' named entity 'systematic reviews' named entity 'DMC' named entity 'Wound infection' named entity 'edema' named entity 'wound dehiscence' named entity 'informed consent' named entity 'necrosis' named entity 'emergency surgery' named entity 'internist' named entity 'sutures' named entity 'obese' named entity 'sutures' named entity 'surgical resident' named entity 'hernias' named entity '0.9' named entity 'adverse effects' named entity 'laparotomies'

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