Incisional hernia related to the umbilical trocar site is probably the most frequent complication after laparoscopic surgical procedures. However, this is an underestimated sequelae of laparoscopic surgery which may involve an important morbidity and an increase in healthcare costs. The incidence of incisional trocar site hernia ranges from 20 to 35% of patients after laparoscopic surgery depending on the different investigations. Prophylactic meshes have been tried in an attempt to reduce the incidence of this complication in obese patients. In that sense, suture-meshes can be an alternative to conventional meshes to improve the incidence of incisional hernias. INDURATE TRIAL aims to test if suture-mesh is capable of reducing the incidence of incisional hernia in patients with risk factors for the development of this frequent complication when compared with conventional monofilament sutures.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
124
Duramesh-suture will be used for trocar closure in the experimental group
Miguel Ángel García Ureña
Madrid, Spain
RECRUITINGIncidence of the umbilical trocar site hernia in each group
Evaluation of the incidence of umbilical trocar site hernia in duramesh group compared with the control group
Time frame: 12 monts
Infectious complications of the wound
Evaluation of the infectious complications related to umbilical wound after laparoscopic surgery. Compare the incidence of these complications in each group
Time frame: 12 months
Seroma and hematoma
Evaluation of the seroma and hematoma related to umbilical wound after laparoscopic surgery. Compare the incidence of these complications in each group
Time frame: 12 months
Intraabdominal events
Evaluation of intraabdominal events (fluid collections, bleeding, peritonitis...) and compare the incidence in each group.
Time frame: 12 months
Skin dehiscence and/or necrosis
Evaluate the incidence of skin complications in each group.
Time frame: 12 months
Early aponeurotic failure (evisceration)
Evaluation of early aponeurotic failure after laparoscopic procuderes and compare the incidence between the two different groups.
Time frame: 12 months
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