Comparison of Postoperative Pain After Hernial Sac Ligation Versus Non-ligation in Inguinal Hernioplasty
Primary Purpose
Inguinal Hernia, Indirect, Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Ligation of indirect hernia sac
Non-ligation of Indirect Inguinal hernia sac
Sponsored by
About this trial
This is an interventional treatment trial for Inguinal Hernia, Indirect focused on measuring Indirect inguinal hernia, Ligation of sac, Postoperative pain
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
Sites / Locations
- Dow University of Health Sciences & Dr. Ruth K. M. Pfau Civil Hospital Karachi
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Ligation
Non-ligation
Arm Description
Ligation of indirect inguinal hernia sac in inguinal hernioplasty patients
Non-Ligation of Indirect inguinal hernia sac/ simple inversion/reduction of indirect inguinal hernia sac in inguinal hernioplasty patients
Outcomes
Primary Outcome Measures
Mean Postoperative pain
Pain scores on visual Analogue scale (0-10) at 12,24,36,48 hours after surgery, Mean will be calculated
Secondary Outcome Measures
Duration of Surgery
Duration of operations in both arms will be recorded and mean will be calculated
Full Information
NCT ID
NCT04079504
First Posted
September 3, 2019
Last Updated
April 23, 2022
Sponsor
Dow University of Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04079504
Brief Title
Comparison of Postoperative Pain After Hernial Sac Ligation Versus Non-ligation in Inguinal Hernioplasty
Official Title
Comparison of Postoperative Pain After Hernial Sac Ligation Versus Non-ligation in Inguinal Hernioplasty.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
July 31, 2021 (Actual)
Study Completion Date
July 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dow University of Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia, Indirect, Postoperative Pain
Keywords
Indirect inguinal hernia, Ligation of sac, Postoperative pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ligation
Arm Type
Active Comparator
Arm Description
Ligation of indirect inguinal hernia sac in inguinal hernioplasty patients
Arm Title
Non-ligation
Arm Type
Experimental
Arm Description
Non-Ligation of Indirect inguinal hernia sac/ simple inversion/reduction of indirect inguinal hernia sac in inguinal hernioplasty patients
Intervention Type
Procedure
Intervention Name(s)
Ligation of indirect hernia sac
Other Intervention Name(s)
Prolene Mesh Placement
Intervention Description
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
Intervention Name(s)
Non-ligation of Indirect Inguinal hernia sac
Other Intervention Name(s)
Prolene Mesh placement
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean Postoperative pain
Description
Pain scores on visual Analogue scale (0-10) at 12,24,36,48 hours after surgery, Mean will be calculated
Time Frame
up to 48 hours
Secondary Outcome Measure Information:
Title
Duration of Surgery
Description
Duration of operations in both arms will be recorded and mean will be calculated
Time Frame
Baseline(at the time of surgery)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Syed A Haider
Organizational Affiliation
Dow University of Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dow University of Health Sciences & Dr. Ruth K. M. Pfau Civil Hospital Karachi
City
Karachi
State/Province
Sindh
ZIP/Postal Code
75290
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All of the individual participant data collected during the trial, after deidentification.
IPD Sharing Time Frame
Beginning 3 months and ending 5 years following article publication.
IPD Sharing Access Criteria
Researchers who provide a methodologically sound proposal.
Citations:
PubMed Identifier
17594052
Citation
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.
Results Reference
background
PubMed Identifier
12774253
Citation
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.
Results Reference
background
PubMed Identifier
8354615
Citation
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.
Results Reference
background
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Comparison of Postoperative Pain After Hernial Sac Ligation Versus Non-ligation in Inguinal Hernioplasty
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