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

NCT ID: NCT04079504

Last Updated: 2022-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2021-07-31

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.

Detailed Description

Amongst general surgical operations done in elective theaters, Hernioplasty is one of the most common. In the current era of new and developing maneuvers of inguinal hernia repairs, the conventional anterior, tension-free approach is considered a daycare method with minimal morbidities. However, mild to medium early postoperative pain is frequent with reported incidence of 21.6% in literature.

The reasons of postoperative pain after hernia repair are multifactorial. Delikoukos et al mentioned that ilioinguinal nerve entrapment or mesh fixation in the periosteum of the pubic tubercle are major etiological factors in the occurrence of postoperative pain. Later studies highlighted that these factors are major culprits in chronic neuralgias with inconsistent involvement in early postoperative pain after mesh repair.This necessitated the exploration of other offenders causing early postoperative pain. In this context, surgeons focused on the role of hernial sac ligation in mesh repairs of indirect inguinal hernias. The notion behind this operative technique is the generation of pain as a consequence of highly pain sensitive parietal peritoneum trauma during ligation and division of hernia sac, the fact which was highlighted by Schulman et al nearly two decades ago. Despite this imperative reason, there is a noteworthy gap on this aspect of early pain with studies still addressing the chronic pain after mesh repair of inguinal hernias. A research reports that frequency of early postoperative pain at day one was significantly higher in 'hernial sac high ligation group' as compared to 'hernial sac non-ligation group' (mean postoperative pain on VAS; 3.5±1.5, and 2.3±1.2 respectively, p<0.05), yet other studies report no significant difference in pain when evaluating different operative techniques.However further studies are needed to establish omission of hernia sac ligation as part of the standard procedure.

Early postoperative pain not only results in delayed recovery and return to normal activity but also adds to the financial constraints of patient and health system.Therefore, the aim of this study is to compare the early postoperative pain after hernia sac ligation as compared to non-ligation in order to establish a definitive role of these operative techniques in the development of early postoperative pain after mesh repair of inguinal hernia so the superior of the two techniques will be employed subsequently.

Conditions

Inguinal Hernia, Indirect; Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ligation

Ligation of indirect inguinal hernia sac in inguinal hernioplasty patients

Group Type: ACTIVE_COMPARATOR

Ligation of indirect hernia sac

Intervention Type: 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.

Non-ligation

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

Group Type: EXPERIMENTAL

Non-ligation of Indirect Inguinal hernia sac

Intervention Type: 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.

Interventions

Ligation of indirect hernia sac

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.

Intervention Type: PROCEDURE

Non-ligation of Indirect Inguinal hernia sac

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.

Intervention Type: PROCEDURE

Other Intervention Names

Prolene Mesh Placement; Prolene Mesh placement

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dow University of Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Syed Ali Haider

Assistant Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Syed A Haider

Role: PRINCIPAL_INVESTIGATOR

Dow University of Health Sciences

Locations

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

Karachi, Sindh, Pakistan

Countries

Pakistan

References

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.

Reference Type: BACKGROUND

PMID: 17594052 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12774253 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8354615 (View on PubMed)

Other Identifiers

IRB-1286/DUHS

Identifier Type: -

Identifier Source: org_study_id