NCT04098380

Small Versus Large Bite Closure of Emergency Midline Laparotomy

A Randomized Controlled Trial on Small Versus Large Bite Closure of Emergency Midline Laparotomy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Mansoura University · Academic / Other
• Sex: All
• Age: 16 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hernia, Ventral

Interventions

Type	Name	Description
PROCEDURE	Small Bite	the bites will be applied with a bite width of 5 mm and inter-suture spacing of 5 mm
PROCEDURE	Larger bite	the bites will be applied with a width of 10 mm and inter-suture spacing of 10 mm

Timeline

• Start date: 2019-09-21
• Primary completion: 2020-12-30
• Completion: 2021-12-30
• First posted: 2019-09-23
• Last updated: 2019-09-23

Locations

1 site across 1 country: Egypt