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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04079504
Other study ID # IRB-1286/DUHS
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2019
Est. completion date July 31, 2021

Study information

Verified date April 2022
Source Dow University of Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Description:

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Study Design


Intervention

Procedure:
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.
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.

Locations

Country Name City State
Pakistan Dow University of Health Sciences & Dr. Ruth K. M. Pfau Civil Hospital Karachi Karachi Sindh

Sponsors (1)

Lead Sponsor Collaborator
Dow University of Health Sciences

Country where clinical trial is conducted

Pakistan, 

References & 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. Epub 2007 Jun 27. — View 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. Epub 2003 May 28. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Duration of Surgery Duration of operations in both arms will be recorded and mean will be calculated Baseline(at the time of surgery)
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