Comparing two stitching methods for closing the inner layer of abdomen in hernia repair surgery

To Assess the Efficacy and Safety of Black Needled Barb Suture with Triangular End Stopper Versus Silver Needled Polyglactin 910 Suture for Peritoneal Flap Closure in TAPP Surgery - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/11/097653

Enrollment

Registered

2025-11-18

Start date

Unknown

Completion date

Unknown

Last updated

2025-12-08

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

Conditions

Health Condition 1: K409- Unilateral inguinal hernia, without obstruction or gangrene

Interventions

Intervention1: Silver Needled Polyglactin 910 suture: Synthetic absorbable surgical suture made from braided Polyglactin 910 along with a surgical needle (silver) and coated with triclosan which will

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male patients between the ages of 18 and 80 with a primary unilateral inguinal hernia suitable for laparoscopic transabdominal preperitoneal (TAPP) surgery 2. Patient willing to give written informed consent and adhere to study procedures

Exclusion criteria

Exclusion criteria: 1. Bilateral inguinal hernia, recurrent inguinal hernia, incarcerated hernia, irreducible hernia, and significant co-morbidities. 2. Patients whose surgical approach got converted from Laparoscopic TAPP to Open surgery 3. Patients who refused to undergo TAPP procedure 4. Patients not fit for TAPP procedure as per surgeons discretion

Design outcomes

Primary

Measure	Time frame
The time taken to close the peritoneal flap from the first bite till the suturing is completed and suture is cut using scissorsTimepoint: On the Day of Surgery in seconds/minutes	—

Secondary

Measure	Time frame
To evaluate intraoperative handling property of black needled & silver needled sutures using Product Usage Assessment Scale using 5-point scale, with 5 being excellent & 1 being poor Timepoint: On the Day of Surgery;To evaluate total operative time from first incision till skin closureTimepoint: On the Day of Surgery;Visual analogue scale (VAS) will be used to assess postoperative painTimepoint: Day of Discharge, Post Surgery Day 7 (1 week), Post Surgery Day 14 (2 weeks), Post Surgery Day 28 (4 weeks);To assess postoperative rate of complicationsTimepoint: Day of Discharge, Post Surgery Day 7 (1 week), Post Surgery Day 14 (2 weeks), Post Surgery Day 28 (4 weeks);To assess the length of hospital stay in daysTimepoint: Day of Discharge;To assess adverse eventsTimepoint: Day of surgery, Day of Discharge, Post Surgery Day 7 (1 week), Post Surgery Day 14 (2 weeks), Post Surgery Day 28 (4 weeks)	—

Measure

Time frame

To evaluate intraoperative handling property of black needled & silver needled sutures using Product Usage Assessment Scale using 5-point scale, with 5 being excellent & 1 being poor Timepoint: On the Day of Surgery;To evaluate total operative time from first incision till skin closureTimepoint: On the Day of Surgery;Visual analogue scale (VAS) will be used to assess postoperative painTimepoint: Day of Discharge, Post Surgery Day 7 (1 week), Post Surgery Day 14 (2 weeks), Post Surgery Day 28 (4 weeks);To assess postoperative rate of complicationsTimepoint: Day of Discharge, Post Surgery Day 7 (1 week), Post Surgery Day 14 (2 weeks), Post Surgery Day 28 (4 weeks);To assess the length of hospital stay in daysTimepoint: Day of Discharge;To assess adverse eventsTimepoint: Day of surgery, Day of Discharge, Post Surgery Day 7 (1 week), Post Surgery Day 14 (2 weeks), Post Surgery Day 28 (4 weeks)

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Countries

India

Contacts

Public ContactDr Mayank Dewangan

Raipur Institute of Medical Sciences

aman.p1002@gmail.com07697766104

Outcome results

None listed

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