Small Versus Large Bite Closure of Emergency Midline Laparotomy (E-STITCH)

Mansoura University

Status: Unknown

Conditions: Hernia, Ventral

Treatments: Procedure: Larger bite; Procedure: Small Bite

Study type: Interventional

Funder types: Other

Identifiers

NCT04098380

Mansoura104

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 16 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients of both sexes aging less than 70 years old

Exclusion criteria

• All procedures which will be performed on elective basis will be excluded
• patients who are pregnant.
• Patients on systemic steroid or chemotherapy
• patients with incisional hernia or fascial defect; and/or relaparotomy within 30-days of another surgical intervention.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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160 participants in 2 patient groups

Small bite

Active Comparator group

Description:

The needle bites will be applied with a bite width of 5 mm and inter-suture spacing of 5 mm

Treatment:

Procedure: Small Bite

Large bite

Active Comparator group

Description:

The needle bites will be applied with a width of 10 mm and inter-suture spacing of 10 mm

Treatment:

Procedure: Larger bite