Small Versus Large Bite Closure of Emergency Midline Laparotomy (E-STITCH)
Primary Purpose
Hernia, Ventral
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Small Bite
Larger bite
Sponsored by
About this trial
This is an interventional prevention trial for Hernia, Ventral
Eligibility 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.
Sites / Locations
- Mansoura university hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Small bite
Large bite
Arm Description
The needle bites will be applied with a bite width of 5 mm and inter-suture spacing of 5 mm
The needle bites will be applied with a width of 10 mm and inter-suture spacing of 10 mm
Outcomes
Primary Outcome Measures
Incidence of incisional hernia
Diagnosis of incisional hernia within 12 months after surgery by clinical examination or by ultrasound
Secondary Outcome Measures
Full Information
NCT ID
NCT04098380
First Posted
September 19, 2019
Last Updated
September 20, 2019
Sponsor
Mansoura University
1. Study Identification
Unique Protocol Identification Number
NCT04098380
Brief Title
Small Versus Large Bite Closure of Emergency Midline Laparotomy
Acronym
E-STITCH
Official Title
A Randomized Controlled Trial on Small Versus Large Bite Closure of Emergency Midline Laparotomy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 21, 2019 (Anticipated)
Primary Completion Date
December 30, 2020 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Ventral
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Small bite
Arm Type
Active Comparator
Arm Description
The needle bites will be applied with a bite width of 5 mm and inter-suture spacing of 5 mm
Arm Title
Large bite
Arm Type
Active Comparator
Arm Description
The needle bites will be applied with a width of 10 mm and inter-suture spacing of 10 mm
Intervention Type
Procedure
Intervention Name(s)
Small Bite
Intervention Description
the bites will be applied with a bite width of 5 mm and inter-suture spacing of 5 mm
Intervention Type
Procedure
Intervention Name(s)
Larger bite
Intervention Description
the bites will be applied with a width of 10 mm and inter-suture spacing of 10 mm
Primary Outcome Measure Information:
Title
Incidence of incisional hernia
Description
Diagnosis of incisional hernia within 12 months after surgery by clinical examination or by ultrasound
Time Frame
12 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sameh Emile, M.D.
Phone
201006767150
Email
sameh200@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sameh Emile, M.D.
Organizational Affiliation
Mansoura University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura university hospital
City
Mansourah
State/Province
Dakahlia
ZIP/Postal Code
35516
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sameh Emile, M.D
Phone
01006267150
Email
sameh200@hotmail.com
First Name & Middle Initial & Last Name & Degree
Sameh H Emile, M.D.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Small Versus Large Bite Closure of Emergency Midline Laparotomy
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