NCT06712212

Brief Summary

To compare the results of Desarda and Darn techniques in inguinal hernia repair in Assiut University Hospital.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 27, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 2, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

December 2, 2024

Status Verified

November 1, 2024

Enrollment Period

2 years

First QC Date

September 27, 2024

Last Update Submit

November 26, 2024

Conditions

Keywords

HerniaDesarda repairDarn repairInguinal Hernia

Outcome Measures

Primary Outcomes (1)

  • Short term recurrence of hernia

    From the day post operative to 6 months after the operation

Study Arms (1)

Inguinal hernia

ACTIVE COMPARATOR
Procedure: Inguinal Hernias repair: DesardaProcedure: Inguinal hernia repair: Darn

Interventions

A splitting incision is made in this sutured medial leaf, partially separating a strip 1.5-2 cm wide. This splitting incision is extended medially up to the pubic symphysis and 1-2 cm beyond the abdominal ring laterally. The medial insertion and lateral continuation of this strip is kept intact. The upper free border of the strip is now sutured to the internal oblique with number 1 Monofilament Polydioxanone Violet continuous sutures all along its length. This will result in the strip of the EOA being placed behind the cord to form a new posterior wall of the inguinal canal. The spermatic cord is placed in the inguinal canal and the lateral leaf of the EOA is sutured to the newly formed medial leaf of the EOA in front of the cord. As before, number 1 Monofilament Polydioxanone Violet continuous sutures were used. Undermining of the newly formed medial leaf on both its surfaces and excision of the bulky cremasteric muscle facilitate its approximation to the lateral leaf

Also known as: Desarda repair of inguinal hernia
Inguinal hernia

Skin and fascia are incised using a regular, oblique inguinal incision to expose the external oblique aponeurosis (EOA) the inguinal canal is opened into by dividing the external oblique aponeurosis through the external ring. After dealing with the hernia sac, a 0-size monofilament suture was used to reconstruct the inguinal bed with a tension-free darn starting with a good strong bite of the tough tendinous structures near the pubic tubercle and emerging out through the lateral edge of the internal oblique/rectus sheath from one side and through the inguinal ligament on the other side. The loosely interwoven bites continued laterally and the back-forming two rows of continuous stitches were placed in a staggered manner to spread the tension between the fibres of the inguinal ligament. Afterwards, the external oblique and other superficial layers with the skin are classically closed

Also known as: Darn repair of inguinal hernia
Inguinal hernia

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • inguinal hernia
  • Age more than 18
  • Male patients

You may not qualify if:

  • simultaneous performance of other surgical procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, Asyut Governorate, 71151, Egypt

Location

MeSH Terms

Conditions

Hernia, InguinalHernia

Condition Hierarchy (Ancestors)

Hernia, AbdominalPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident General Surgery

Study Record Dates

First Submitted

September 27, 2024

First Posted

December 2, 2024

Study Start

March 1, 2023

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

December 2, 2024

Record last verified: 2024-11

Locations