Small Versus Large Bite Closure of Emergency Midline Laparotomy

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04098380

Acronym

E-STITCH

Enrollment

160

Registered

2019-09-23

Start date

2019-09-21

Completion date

2021-12-30

Last updated

2019-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hernia, Ventral

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.

Interventions

PROCEDURESmall Bite

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

PROCEDURELarger bite

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

16 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

Egypt

Contacts

Primary ContactSameh Emile, M.D.

sameh200@hotmail.com201006767150

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026