Small Versus Large Bite Closure of Emergency Midline Laparotomy

NCT04098380 | Unknown

• 1 other identifier: Mansoura104
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Hernia, Ventral

Outcome Measures

Primary Outcomes (1)

• Incidence of incisional hernia

  Diagnosis of incisional hernia within 12 months after surgery by clinical examination or by ultrasound

  12 months after surgery

Study Arms (2)

Small bite

ACTIVE COMPARATOR

The needle bites will be applied with a bite width of 5 mm and inter-suture spacing of 5 mm

Procedure: Small Bite

Large bite

ACTIVE COMPARATOR

The needle bites will be applied with a width of 10 mm and inter-suture spacing of 10 mm

Procedure: Larger bite

Interventions

Small Bite PROCEDURE

the bites will be applied with a bite width of 5 mm and inter-suture spacing of 5 mm

Small bite

Larger bite PROCEDURE

the bites will be applied with a width of 10 mm and inter-suture spacing of 10 mm

Large bite

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients of both sexes aging less than 70 years old

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura university hospital

Al Mansurah, Dakahlia Governorate, 35516, Egypt

RECRUITING

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Sameh Emile, M.D.

  Mansoura University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sameh Emile, M.D.

CONTACT

201006767150; sameh200@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of surgery

Study Record Dates

• First Submitted: September 19, 2019
• First Posted: September 23, 2019
• Study Start: September 21, 2019
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2021
• Last Updated: September 23, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)