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

September 20, 2019 updated by: Sameh Emile, Mansoura University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Dakahlia
      • Mansourah, Dakahlia, Egypt, 35516
        • Recruiting
        • Mansoura University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 70 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Small bite
The needle bites will be applied with a bite width of 5 mm and inter-suture spacing of 5 mm
Procedure: Small Bite
the bites will be applied with a bite width of 5 mm and inter-suture spacing of 5 mm
ACTIVE_COMPARATOR: Large bite
The needle bites will be applied with a width of 10 mm and inter-suture spacing of 10 mm
Procedure: Larger bite
the bites will be applied with a width of 10 mm and inter-suture spacing of 10 mm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of incisional hernia
Time Frame: 12 months after surgery
Diagnosis of incisional hernia within 12 months after surgery by clinical examination or by ultrasound
12 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 21, 2019

Primary Completion (ANTICIPATED)

December 30, 2020

Study Completion (ANTICIPATED)

December 30, 2021

Study Registration Dates

First Submitted

September 19, 2019

First Submitted That Met QC Criteria

September 20, 2019

First Posted (ACTUAL)

September 23, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 23, 2019

Last Update Submitted That Met QC Criteria

September 20, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mansoura104

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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