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Small Versus Large Bite Closure of Emergency Midline Laparotomy

NCT04098380 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2019-09-23

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Principal Investigators

  • Sameh Emile, M.D. · Mansoura University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-21
Primary Completion
2020-12-30
Completion
2021-12-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04098380 on ClinicalTrials.gov