An interventional study of Small Bite and Larger bite in Hernia, Ventral, sponsored by Mansoura University. Status unknown at 1 site in Egypt. Open to participants aged 16 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-09-23.
Sponsored by Mansoura University · Not applicable, Interventional, and Prevention
In daily practice, midline laparotomy is an incision frequently performed by surgeons to achieve a rapid and wide access to the abdomen. However, incisional hernia stands as the most common complication following this type of incision, with an incidence reaching up to 20% and even higher in the case of emergency laparotomy.
A recent randomized controlled trial compared small bite sutures and large bite closure of elective midline laparotomy and reported a significant decrease of incisional hernia rate from 18% to 5.6% in favor of small-bite technique. These promising results were subsequently confirmed in a wide-scale multicenter double-blinded randomized trial, the STITCH study.
The investigators will conduct this randomized controlled trial to compare the small tissue bite (SB) technique and the large bite (LB) technique for closure of emergency midline laparotomy. The main outcome of the study will be the incidence of incisional hernia within one year after surgery.
254 studies on the registry are indexed under Hernia, Ventral; 46 are open to participants now.
This study's planned enrollment of 160 is above the median of 95 across 159 interventional studies indexed under Hernia, Ventral.
Browse Hernia, Ventral studies →Mansoura University is the lead sponsor of 1,077 studies on the registry; 183 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
The needle bites will be applied with a bite width of 5 mm and inter-suture spacing of 5 mm
Procedure: Small Bite
The needle bites will be applied with a width of 10 mm and inter-suture spacing of 10 mm
Procedure: Larger bite
the bites will be applied with a bite width of 5 mm and inter-suture spacing of 5 mm
the bites will be applied with a width of 10 mm and inter-suture spacing of 10 mm
Incidence of incisional hernia
Diagnosis of incisional hernia within 12 months after surgery by clinical examination or by ultrasound
Time frame: 12 months after surgery
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Mansoura University