To Compare the Skin Incision Made by the Electrocautery and Scalpel in Inguinal Hernia Repair

NCT05666973 | Unknown DMC

• 1 other identifier: SKJha
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The Groin hernia repair is a commonly performed general surgery procedure in both adults and children with inguinal hernias constituting more than 95% of all groin hernia repairs. Inguinal hernia repair is a commonly performed surgical procedure in our part of the world and is one of the common cause of hospital admission from the emergency or out patient department. Traditionally, surgical skin incisions have been made with surgical scalpel while modern method of making incisions with electrocautery had made it more sharp, precise and less time consuming. The cases of inguinal hernia are being managed in our center, Tribhuvan University Teaching Hospital. Generally, these patients are seen by the residents and supervised by the faculties in the emergency and in OPD and later if required admitted in the wards. Clinical examination and imaging are done for the diagnosis . Then severity assessment is performed and the management is done accordingly. The proposed study will be a hospital based comparative study and aims to observe the overview of the surgical management of OPD based day care surgery of inguinal hernia and also to observe whether the surgical incision is being performed with scalpel or electrocautery. The patients fulfilling the inclusion criteria are selected for the study. Sample will be selected by non-probability (convenience) method and study variables will be recorded in proforma. Statistical analysis will be done using SPSS version 23. Results obtained from the study will be reviewed and discussed with published literature.

Conditions

Post-operative Pain, Acute

Outcome Measures

Primary Outcomes (1)

• To Compare the incidence of post-operative pain between two groups.

  For assessment of pain; visual analog scale will be used in every patients.

  Assessment of Pain will be done • immediately after surgery, 30 minutes , 1 hour • Day 1 to day 5 (Telephone conversation)

Secondary Outcomes (2)

• To compare the post-operative analgesic dose requirement between the two groups.

  Day 1 to Day 5

• To Compare the incidence of other complications like SSI, Hematoma, Seroma and Urinary retention between the two groups.

  Day 1 to Day 5

Study Arms (2)

Group 1: Scalpel

ACTIVE COMPARATOR

Skin Incision for inguinal hernia repair will be given by Stainless steel blade no.10. Open Mesh Hernioplasty

Procedure: Open Mesh Hernioplasty

Group 2 : Electrocautery

EXPERIMENTAL

Open Mesh Hernioplasty Skin Incision for inguinal hernia repair will be given by following: * Cautery machine: Erbe VIO 300 S * Cut setting: Cut:30 Coagulate:30 * Cautery tip (tip pointed) * Mode: Monopolar

Procedure: Open Mesh Hernioplasty

Interventions

Open Mesh Hernioplasty PROCEDURE

* Steps of surgery: * Injection Ceftriaxone 50 mg/kg iv stat dose will be given pre-operatively * Incision: * Incision given over medial 3/5 and 2.5 cms above and parallel to inguinal ligament extending from pubic tubercle upto 1 cm lateral to mid point of inguinal ligament. * bleeding controlled by forcep coagulation. * Cut the subcutaneous tissues,external oblique aponeurosis opened in layers * Nerve Iliohypogastric \& ilioinguinal will be preserved (by taking aside from the field) * Intra-operative Injection Tramadol(50 mg) and ondansetron(4 mg) iv stat dose given * Sac ligated with Polygalactin 2-0 suture. * Lichtenstein method of repair * Mesh type: large pore polypropylene mesh * Mesh size: 3 x 6 inches(7.5 x 15 cms) * Mesh Fixation: polypropylene 2-0 * External oblique closure * Skin closure: Ethilon 2 - 0 suture

Group 1: Scalpel; Group 2 : Electrocautery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥ 18 years old who are operated with the diagnosis of inguinal hernia.

You may not qualify if:

• Patients with recurrent inguinal hernia
• Patients presenting with incarcerated, irreducible and strangulated hernia
• Bilateral Inguinal Hernia
• Patient taking steroids
• Patient with contraindication to NSAIDs such as CKD, Drug hypersensitivity etc
• Patients who do not give written consent

Sponsors & Collaborators

• Tribhuvan University Teaching Hospital, Institute Of Medicine.: lead

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Yogendra Pd Singh, MBBS,MS

  Tribhuvan University Teaching Hospital, Institute Of Medicine.

  STUDY CHAIR

Central Study Contacts

Sanjeeb kr Jha, MBBS

CONTACT

+977-9851127004; dr.sanjeeb.jha@gmail.com

Bikal Ghimire, MCh

CONTACT

+977-9851095679; bikalghimire@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Patients will be randomly distributed in two groups manually by writing specific numbers that will be concealed in sequentially numbered, opaque sealed envelopes. The envelopes will be opened by an attending nurse not involved in the study just before the procedure. The incision will be given by the attending general surgery resident who will perform the inguinal hernia repair. The assessment of pain and data collection, data analysis will be done by principle investigator who is blinded to procedure. Thus, the patients and investigating and analyzing personal will be blinded to the procedure.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master of Surgery Resident, General Surgery

Model Details: Participants are assigned to study where two groups of treatments Group 1 (Scalpel) and Group 2 (Electrocautery) are given so that Group 1 will receive skin incision only by Scalpel and another group will receive skin incision by Electrocautery for the duration of study.

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: December 28, 2022
• Study Start: January 1, 2023
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: January 10, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share