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Comparison of two different types of abdomen closure after surgery

Small bite continuous suture closure vs. mass closure of midline abdominal incision in emergency- A prospective, double-blind, multi-centric, randomized controlled trial - SMILE 2.0 TRIAL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/07/055903
Enrollment
680
Registered
2023-07-31
Start date
Unknown
Completion date
Unknown
Last updated
2023-10-16

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Small Bite closure of laparotomy incision: . Patients randomized to receive small bites technique, wound closure will be done by placement of at least twice as many stitches as the inci

Sponsors

All India Institute of Medical Sciences,Bhubaneswar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged 18 years or older and scheduled to undergo emergency ab-dominal surgery through a midline incision. (Patients managed with damage control surgery and abdomen closed after 48-72 hours, once stable will be in-cluded)

Exclusion criteria

Exclusion criteria: Patients with history of incisional Hernia Patients with previous abdominal incisions/scar H/O Chronic cough ASA (American society of Anaesthesiology) grade 3 & 4 Refractory hypotension Septic shock Patients with active malignancy Pregnancy Patients who have undergone stoma creation during the emergency surgery, except loop ileostomy or loop colostomy. Patients expected to undergo a second laparotomy within a period of 1 year. Patient could not extubated after surgery.

Design outcomes

Primary

MeasureTime frame
Incisional herniaTimepoint: One year

Secondary

MeasureTime frame
Burst abdomen Timepoint: 30 days;Surgical Site InfectionTimepoint: 30 days

Countries

India

Contacts

Public ContactPankaj Kumar

All India Institute of Medical sciences Bhubaneswar

drpkushwaha@gmail.com09711090814

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026