Inguinal Hernia, IndirectNCT04079504
Comparison of Postoperative Pain After Hernial Sac Ligation Versus Non-ligation in Inguinal Hernioplasty
A study testing Ligation of indirect hernia sac and Non-ligation of Indirect Inguinal hernia sac in people with Inguinal Hernia, Indirect and Postoperative Pain, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inguinal Hernia, Indirect, Postoperative Pain
- What is being tested?
- Ligation of indirect hernia sac and Non-ligation of Indirect Inguinal hernia sac
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2019to 31 Jul 2021
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients ≥15 years of age, of either gender having Incomplete indirect inguinal hernia with or without direct concurrent hernia as mentioned in operational definition.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Dow University of Health Sciences & Dr. Ruth K. M. Pfau Civil Hospital Karachi
Karachi, Sindh, 75290
About this study
Official title: Comparison of Postoperative Pain After Hernial Sac Ligation Versus Non-ligation in Inguinal Hernioplasty.
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.
Read the 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
- Being tested
- Ligation of indirect hernia sac, Non-ligation of Indirect Inguinal hernia sac
- Keywords
- Indirect inguinal hernia, Ligation of sac, Postoperative pain
- Medical subject headings
- Hernia, Inguinal, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ligation of indirect hernia sacProcedure or surgery
Also called Prolene Mesh Placement
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 of Indirect Inguinal hernia sacProcedure or surgery
Also called Prolene Mesh placement
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.
| Study group | Role | What they receive |
|---|---|---|
| Ligation | Active comparator | Ligation of indirect inguinal hernia sac in inguinal hernioplasty patients Receives: 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 Receives: Procedure: Non-ligation of Indirect Inguinal hernia sac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Postoperative pain
Pain scores on visual Analogue scale (0-10) at 12,24,36,48 hours after surgery, Mean will be calculated
Measured: up to 48 hours
Secondary outcomes (1)
Duration of Surgery
Duration of operations in both arms will be recorded and mean will be calculated
Measured: Baseline(at the time of surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start1 Oct 2019
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Inguinal Hernia, IndirectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Syed Ali Haider, Dow University of Health Sciences
- Investigators
- Syed A Haider, Principal investigator, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04079504
- Sponsor's protocol ID
- IRB-1286/DUHS
- Status last verified
- Apr 2022
- First submitted
- 3 Sep 2019
- Last updated
- 26 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Publications
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.
PubMed 17594052Mohta 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.
PubMed 12774253Shulman AG, Amid PK, Lichtenstein IL. Ligation of hernial sac. A needless step in adult hernioplasty. Int Surg. 1993 Apr-Jun;78(2):152-3.
PubMed 8354615