Small Versus Large Bite Closure of Emergency Midline Laparotomy

Not Applicable

• Conditions: Hernia, Ventral
• Interventions: Procedure: Larger bite; Procedure: Small Bite

• Registration Number: NCT04098380
• Lead Sponsor: Mansoura University

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2019-09
• Study First Submitted: 2019-09-19
• Study First Submitted QC: 2019-09-20
• Last Update Submitted: 2019-09-20
• Study Start: 2019-09-21
• Study First Posted: 2019-09-23
• Last Update Posted: 2019-09-23
• Primary Completion: 2020-12-30
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Large bite	Larger bite	The needle bites will be applied with a width of 10 mm and inter-suture spacing of 10 mm
Small bite	Small Bite	The needle bites will be applied with a bite width of 5 mm and inter-suture spacing of 5 mm

Primary Outcome Measures

Name	Time	Method
Incidence of incisional hernia	12 months after surgery	Diagnosis of incisional hernia within 12 months after surgery by clinical examination or by ultrasound

Trial Locations

Locations (1)

Mansoura university hospital; 🇪🇬 Mansourah, Dakahlia, Egypt