Small Versus Large Bite Closure of Emergency Midline Laparotomy

Hernia, Ventral Clinical Trial

— E-STITCH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04098380
• Other study ID #: Mansoura104
• Status: Recruiting
• Phase: N/A
• Start date: September 21, 2019
• Est. completion date: December 30, 2021

Study information

• Verified date: September 2019
• Source: Mansoura University
• Contact: Sameh Emile, M.D.
• Phone: 201006767150
• Email: sameh200[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Emergencies
• Hernia, Ventral

Intervention

Procedure:
• Small Bite
the bites will be applied with a bite width of 5 mm and inter-suture spacing of 5 mm
• Larger bite
the bites will be applied with a width of 10 mm and inter-suture spacing of 10 mm

Locations

Country	Name	City	State
Egypt	Mansoura university hospital	Mansourah	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of incisional hernia	Diagnosis of incisional hernia within 12 months after surgery by clinical examination or by ultrasound	12 months after surgery