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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04098380
Recruitment Status : Recruiting
First Posted : September 23, 2019
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Sameh Emile, 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.


Condition or disease Intervention/treatment Phase
Hernia, Ventral Procedure: Small Bite Procedure: Larger bite Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial on Small Versus Large Bite Closure of Emergency Midline Laparotomy
Estimated Study Start Date : September 21, 2019
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

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




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04098380


Contacts
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Contact: Sameh Emile, M.D. 201006767150 sameh200@hotmail.com

Locations
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Egypt
Mansoura university hospital Recruiting
Mansourah, Dakahlia, Egypt, 35516
Contact: Sameh Emile, M.D    01006267150    sameh200@hotmail.com   
Contact: Sameh H Emile, M.D.         
Sponsors and Collaborators
Mansoura University
Investigators
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Principal Investigator: Sameh Emile, M.D. Mansoura University
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Responsible Party: Sameh Emile, Lecturer of surgery, Mansoura University
ClinicalTrials.gov Identifier: NCT04098380    
Other Study ID Numbers: Mansoura104
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Emergencies
Hernia, Ventral
Disease Attributes
Pathologic Processes
Hernia
Pathological Conditions, Anatomical
Hernia, Abdominal