Small bite continuous suture closure vs. mass closure of midline abdominal incision in emergency(SMILE Trial)

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/06/026210

Enrollment

680

Registered

2020-06-29

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: K352- Acute appendicitis with generalized peritonitis Health Condition 2: K319- Disease of stomach and duodenum, unspecified Health Condition 3: K669- Disorder of peritoneum, unspecified Health Condition 4: K650- Generalized (acute) peritonitis Health Condition 5: K565- Intestinal adhesions [bands] withobstruction (postinfection)

Interventions

Intervention1: Small bite continuous suture closure of emergency midline laprotomy: Small bite continuous suture closure of emergency laprotomy with 2-0 PDS suture Control Intervention1: mass closure

Eligibility

Inclusion criteria

Inclusion criteria: any patient with age more than 18 years, undergoing emergency midline laprotomy

Exclusion criteria

Exclusion criteria: Patients with previous abdominal incisions/scar H/O Chronic cough ASA(American society of Anesthesiology) grade 3 & 4 Refractory hypotension, Septic shock Pregnancy

Design outcomes

Primary

Measure	Time frame
Development of Incisional Hernia at thirty- six months.Timepoint: Development of Incisional Hernia at thirty- six months.	—

Secondary

Measure	Time frame
1. Surgical site infection and Burst abdomen in post-operative period. 2.Quality of life at 3 months, 6 months and one year and three year.Timepoint: 1 year and 3 year	—

Countries

India

Contacts

Public ContactDr Pankaj Kumar

All India Institute of Medical Sciences,Bhubaneswar

drpkushwaha@gmail.com9711090814

Outcome results

None listed

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