Comparison of Postoperative Pain After Hernial Sac Ligation Versus Non-ligation in Inguinal Hernioplasty

NCT04079504 | Completed

• 1 other identifier: IRB-1286/DUHS
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This study is intends to compare mean postoperative pain scores for 48-hours in patients undergoing Inguinal hernioplasty with and without hernia sac ligation in Department of Surgery, Dow University of Health Sciences \& Dr. Ruth K. M. Pfau Civil Hospital Karachi.Half of the patients undergoing inguinal hernioplasty will have their indirect inguinal sacs ligated whereas other half will have non-ligation and inversion of sac.

Conditions

Inguinal Hernia, Indirect; Postoperative Pain

Keywords

Indirect inguinal hernia; Ligation of sac; Postoperative pain

Outcome Measures

Primary Outcomes (1)

• Mean Postoperative pain

  Pain scores on visual Analogue scale (0-10) at 12,24,36,48 hours after surgery, Mean will be calculated

  up to 48 hours

Secondary Outcomes (1)

• Duration of Surgery

  Baseline(at the time of surgery)

Study Arms (2)

Ligation

ACTIVE COMPARATOR

Ligation of indirect inguinal hernia sac in inguinal hernioplasty patients

Procedure: Ligation of indirect hernia sac

Non-ligation

EXPERIMENTAL

Non-Ligation of Indirect inguinal hernia sac/ simple inversion/reduction of indirect inguinal hernia sac in inguinal hernioplasty patients

Procedure: Non-ligation of Indirect Inguinal hernia sac

Interventions

Ligation of indirect hernia sac PROCEDURE

Indirect inguinal hernia sac will be separated from the spermatic cord and contents of the sac will be reduced before ligating it at the deep inguinal ring.

Also known as: Prolene Mesh Placement

Ligation

Non-ligation of Indirect Inguinal hernia sac PROCEDURE

the indirect inguinal hernia sac will be separated from the spermatic cord and reduced/inverted in to the peritoneal cavity through the deep inguinal ring along with its contents.

Also known as: Prolene Mesh placement

Non-ligation

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥15 years of age, of either gender having Incomplete indirect inguinal hernia with or without direct concurrent hernia as mentioned in operational definition.

You may not qualify if:

• Complete inguinal hernias.
• Patients having obstructed and/or strangulated inguinal hernia.
• Recurrent inguinal hernias.
• patients with ipsilateral synchronous inguinoscrotal pathologies e.g. hydrocele, testicular malignancy

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

Dow University of Health Sciences & Dr. Ruth K. M. Pfau Civil Hospital Karachi

Karachi, Sindh, 75290, Pakistan

Location

Related Publications (3)

• Delikoukos S, Lavant L, Hlias G, Palogos K, Gikas D. The role of hernia sac ligation in postoperative pain in patients with elective tension-free indirect inguinal hernia repair: a prospective randomized study. Hernia. 2007 Oct;11(5):425-8. doi: 10.1007/s10029-007-0249-9. Epub 2007 Jun 27.

  PMID: 17594052 BACKGROUND

• Mohta A, Jain N, Irniraya KP, Saluja SS, Sharma S, Gupta A. Non-ligation of the hernial sac during herniotomy: a prospective study. Pediatr Surg Int. 2003 Aug;19(6):451-2. doi: 10.1007/s00383-002-0940-y. Epub 2003 May 28.

  PMID: 12774253 BACKGROUND

• Shulman AG, Amid PK, Lichtenstein IL. Ligation of hernial sac. A needless step in adult hernioplasty. Int Surg. 1993 Apr-Jun;78(2):152-3.

  PMID: 8354615 BACKGROUND

MeSH Terms

Conditions

Hernia, Inguinal; Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Officials

• Syed A Haider

  Dow University of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Study Record Dates

• First Submitted: September 3, 2019
• First Posted: September 6, 2019
• Study Start: October 1, 2019
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: April 26, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

PA (1)