Small Versus Large Bite Closure of Emergency Midline Laparotomy
NCT ID: NCT04098380
Last Updated: 2019-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
160 participants
INTERVENTIONAL
2019-09-21
2021-12-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Small bite
The needle bites will be applied with a bite width of 5 mm and inter-suture spacing of 5 mm
Small Bite
the bites will be applied with a bite width of 5 mm and inter-suture spacing of 5 mm
Large bite
The needle bites will be applied with a width of 10 mm and inter-suture spacing of 10 mm
Larger bite
the bites will be applied with a width of 10 mm and inter-suture spacing of 10 mm
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
16 Years
70 Years
ALL
No
Sponsors
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Mansoura University
OTHER
Responsible Party
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Sameh Emile
Lecturer of surgery
Principal Investigators
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Sameh Emile, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mansoura University
Locations
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Mansoura university hospital
Al Mansurah, Dakahlia Governorate, Egypt
Countries
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Central Contacts
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Facility Contacts
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Sameh H Emile, M.D.
Role: backup
Other Identifiers
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Mansoura104
Identifier Type: -
Identifier Source: org_study_id
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