Darn Vs. Lichtenstein Hernia OutcomesNCT06681454
Comparing Darn and Lichtenstein Repair for Bilateral Inguinal Hernias in Adult Males in a Low-Resource Setting
An observational study of Darn Vs. Lichtenstein Hernia Outcomes and Outcomes of Darn and Lichtenstein Hernia Repairs, run by Sudan Medical Specialization Board at 1 site in Sudan.
Trial summary
This retrospective study evaluates the efficacy of Darn versus Lichtenstein repair methods in treating bilateral inguinal hernias in adult males within a low-resource setting in Sudan. Read more about this study
- Who is it for?
- Ages 16 to 85 years, men only
- Conditions the study is for
- Darn Vs. Lichtenstein Hernia Outcomes, Outcomes of Darn and Lichtenstein Hernia Repairs, Bilateral Inguinal Hernia: Darn Vs. Lichtenstein
- How many people
- 75 participants
- Where
- 1 siteSudan
- Study dates
- 11 Jan 2021to 22 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 16 to 85 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will consist of adult male patients aged 16 to 85 years who present with bilateral primary direct or indirect inguinal hernias at Al-Waleedeen Specialized Hospital in Gezira State, Sudan. Participants will be selected based on their medical records and will have undergone open elective hernia repair using either the Darn or Lichtenstein technique during the recruitment period from January 2021 to October 2023.
Who may be able to join
- Male patients aged 16 to 85 years. Diagnosed with bilateral primary direct or indirect inguinal hernias. Underwent open elective repairs using either the Lichtenstein or Darn method.
Who cannot join
- Patients with recurrent hernias. Female patients. Patients with unilateral hernias. Those undergoing laparoscopic or emergency surgery. Patients with poorly controlled diabetes (A1C > 7). Patients diagnosed with cancer, tuberculosis. Patients with giant inguinoscrotal hernias.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Comparative Cohort Analysis of Darn and Lichtenstein Repair Methods for Bilateral Inguinal Hernias in Adult Males in a Low-Resource Setting: a Single-Centre Study in Sudan
This retrospective study evaluates the efficacy of Darn versus Lichtenstein repair methods in treating bilateral inguinal hernias in adult males within a low-resource setting in Sudan. The study aims to determine which surgical technique results in better postoperative outcomes, focusing on complication rates, recurrence, and recovery times. Data for this analysis will be sourced from medical records of patients who underwent these procedures between January 2021 and October 2023 at Al-Waleedeen Specialized Hospital.
Read the detailed description
Study Design and Setting
This is a retrospective comparative cohort study undertaken at Al-Waleedeen Specialized Hospital, a governmental tertiary care center in Gezira State, Sudan. The study period spans from January 2021 to October 2023, involving adult males diagnosed with bilateral inguinal hernias.
Study Procedures
Medical records will be systematically reviewed to extract data on surgical technique employed-either Darn or Lichtenstein method. The review will document specific procedural details such as the type of anesthesia used, duration of the surgeries, surgical team composition, and intraoperative management techniques. Information on immediate postoperative care will also be collected, focusing on pain management strategies and mobilization protocols.
Data Collection
The data collection will emphasize capturing precise measures related to surgical outcomes. This includes the exact nature and timing of any postoperative complications (e.g., infection, hematoma, seroma), the precise time to recurrence if applicable, and detailed recovery timelines including return to daily activities and work. All data points will be aligned with the definitions set forth in the STROBE guidelines to maintain consistency and reliability in reporting.
Analytical Methods
The primary analytical approach will involve comparing the frequency and severity of complications between the two surgical methods. Statistical methods will include chi-square tests for categorical data and t-tests for continuous variables, with a significance level set at p<0.05. Kaplan-Meier curves may be used to estimate recurrence rates over the follow-up period, and a Cox proportional hazards model will assess risk factors for recurrence and complications.
Outcome Measures
The main outcome measures will focus on:
Short-term complications within the first three months post-surgery. Long-term hernia recurrence over the follow-up period. Recovery timelines, quantified by time until return to usual activities and work.
Ethical Considerations
The study protocol has been reviewed and approved by the Institutional Review Board at Al-Waleedeen Specialized Hospital. All data will be de-identified to ensure confidentiality and compliance with ethical standards for research involving human subjects.
- Conditions
- Darn Vs. Lichtenstein Hernia Outcomes, Outcomes of Darn and Lichtenstein Hernia Repairs, Bilateral Inguinal Hernia: Darn Vs. Lichtenstein
- Keywords
- Retrospective cohort study, Low-resource setting, Medical records analysis, Bilateral inguinal hernia, Lichtenstein repair method, Darn repair method
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lichtenstein Repair Cohort | This group consists of adult male patients who underwent bilateral inguinal hernia repair using the Lichtenstein technique. The Lichtenstein method involves the use of a synthetic mesh to provide support to the weakened abdominal wall, minimizing the risk of recurrence and promoting quicker recovery. | |
| Darn Repair Cohort | This group comprises adult male patients who underwent bilateral inguinal hernia repair using the Darn technique. The Darn method is a tension-free repair technique that utilizes the patient's own tissue without the use of mesh, aimed at reducing postoperative pain and complication rates. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication Rates
Number of patients experiencing postoperative complications. Unit of Measure: Percentage of total patients.
Measured: Up to 3 months post-surgery
Hernia Recurrence Rates
Number of patients with recurrence of hernia after initial repair. Unit of Measure: Percentage of total patients.
Measured: Up to 3 months post-surgery .
Secondary outcomes (3)
Postoperative Pain Level
Average pain scores reported by patients using the Visual Analog Scale. Unit of Measure: Pain score on a scale from 0 (no pain) to 10 (worst possible pain).
Measured: Assessed at 24 hours, 72 hours, and 1 week post-surgery.
Duration of Hospital Stay
Length of hospital stay post-surgery. Unit of Measure: Number of days from surgery to discharge.
Measured: From date of surgery to discharge, within 30 days post-surgery
Recovery Times
Time taken for patients to return to usual activities/work post-surgery. Unit of Measure: Number of days from surgery to return to usual activities.
Measured: Assessed at 2 weeks, 1 month, and 3 months post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start11 Jan 2021
- Primary completion11 Oct 2023
- Study completion22 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Darn Vs. Lichtenstein Hernia OutcomesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sudan Medical Specialization Board
- Sponsor type
- Other government
- Collaborators
- Sudan Medical Specialization Board (SMSB)
- Responsible party
- Principal investigator, Alsadig Suliman, Federal Ministry of Health, Sudan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06681454
- Sponsor's protocol ID
- SMSB-HERNIA-001-2024
- Other IDs
- SMSB-HERNIA-001-2024
- Status last verified
- Nov 2024
- First submitted
- 24 Oct 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared publicly due to several considerations. First, the data includes sensitive personal health information, which must be protected to comply with privacy regulations and ethical standards. Additionally, the study is conducted in a low-resource setting, where data management and sharing capabilities may be limited. Ensuring the confidentiality and anonymity of participants is paramount, and sharing IPD could compromise these ethical obligations. Finally, the data will be used exclusively for the purpose of this study to inform clinical practice within the context of the local healthcare system, rather than for broader dissemination.
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Comparative Cohort Analysis of Darn and Lichtenstein Repair Methods for Bilateral Inguinal Hernias in Adult Males in a Low-Resource Setting: a Single-Centre Study in Sudan
- ClinicalTrials.gov ID
- NCT06681454
- Acronym / sponsor ID
- SMSB-HERNIA-001-2024
- Conditions
- Darn Vs. Lichtenstein Hernia Outcomes, Outcomes of Darn and Lichtenstein Hernia Repairs, Bilateral Inguinal Hernia: Darn Vs. Lichtenstein
- Keywords
- Retrospective cohort study, Low-resource setting, Medical records analysis, Bilateral inguinal hernia, Lichtenstein repair method, Darn repair method
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Sudan Medical Specialization BoardOther government
- Collaborators
- Sudan Medical Specialization Board (SMSB)
- Study start
- 11 Jan 2021 (actual)
- Primary completion
- 11 Oct 2023 (actual)
- Study completion
- 22 Sep 2024 (actual)
- First posted
- 8 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This retrospective study evaluates the efficacy of Darn versus Lichtenstein repair methods in treating bilateral inguinal hernias in adult males within a low-resource setting in Sudan. The study aims to determine which surgical technique results in better postoperative outcomes, focusing on complication rates, recurrence, and recovery times. Data for this analysis will be sourced from medical records of patients who underwent these procedures between January 2021 and October 2023 at Al-Waleedeen Specialized Hospital.
Detailed description
Study Design and Setting
This is a retrospective comparative cohort study undertaken at Al-Waleedeen Specialized Hospital, a governmental tertiary care center in Gezira State, Sudan. The study period spans from January 2021 to October 2023, involving adult males diagnosed with bilateral inguinal hernias.
Study Procedures
Medical records will be systematically reviewed to extract data on surgical technique employed-either Darn or Lichtenstein method. The review will document specific procedural details such as the type of anesthesia used, duration of the surgeries, surgical team composition, and intraoperative management techniques. Information on immediate postoperative care will also be collected, focusing on pain management strategies and mobilization protocols.
Data Collection
The data collection will emphasize capturing precise measures related to surgical outcomes. This includes the exact nature and timing of any postoperative complications (e.g., infection, hematoma, seroma), the precise time to recurrence if applicable, and detailed recovery timelines including return to daily activities and work. All data points will be aligned with the definitions set forth in the STROBE guidelines to maintain consistency and reliability in reporting.
Analytical Methods
The primary analytical approach will involve comparing the frequency and severity of complications between the two surgical methods. Statistical methods will include chi-square tests for categorical data and t-tests for continuous variables, with a significance level set at p<0.05. Kaplan-Meier curves may be used to estimate recurrence rates over the follow-up period, and a Cox proportional hazards model will assess risk factors for recurrence and complications.
Outcome Measures
The main outcome measures will focus on:
Short-term complications within the first three months post-surgery. Long-term hernia recurrence over the follow-up period. Recovery timelines, quantified by time until return to usual activities and work.
Ethical Considerations
The study protocol has been reviewed and approved by the Institutional Review Board at Al-Waleedeen Specialized Hospital. All data will be de-identified to ensure confidentiality and compliance with ethical standards for research involving human subjects.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lichtenstein Repair Cohort | – | –This group consists of adult male patients who underwent bilateral inguinal hernia repair using the Lichtenstein technique. The Lichtenstein method involves the use of a synthetic mesh to provide support to the weakened abdominal wall, minimizing the risk of recurrence and promoting quicker recovery. |
| Darn Repair Cohort | – | –This group comprises adult male patients who underwent bilateral inguinal hernia repair using the Darn technique. The Darn method is a tension-free repair technique that utilizes the patient's own tissue without the use of mesh, aimed at reducing postoperative pain and complication rates. |
Who may qualify
- Ages
- 16 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will consist of adult male patients aged 16 to 85 years who present with bilateral primary direct or indirect inguinal hernias at Al-Waleedeen Specialized Hospital in Gezira State, Sudan. Participants will be selected based on their medical records and will have undergone open elective hernia repair using either the Darn or Lichtenstein technique during the recruitment period from January 2021 to October 2023.
Key inclusion criteria (1 listed)
- Male patients aged 16 to 85 years. Diagnosed with bilateral primary direct or indirect inguinal hernias. Underwent open elective repairs using either the Lichtenstein or Darn method.
Key exclusion criteria (1 listed)
- Patients with recurrent hernias. Female patients. Patients with unilateral hernias. Those undergoing laparoscopic or emergency surgery. Patients with poorly controlled diabetes (A1C > 7). Patients diagnosed with cancer, tuberculosis. Patients with giant inguinoscrotal hernias.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Complication Rates
Time frame: Up to 3 months post-surgery
Number of patients experiencing postoperative complications. Unit of Measure: Percentage of total patients.
Hernia Recurrence Rates
Time frame: Up to 3 months post-surgery .
Number of patients with recurrence of hernia after initial repair. Unit of Measure: Percentage of total patients.
3 secondary outcomes
Postoperative Pain Level
Time frame: Assessed at 24 hours, 72 hours, and 1 week post-surgery.
Duration of Hospital Stay
Time frame: From date of surgery to discharge, within 30 days post-surgery
Recovery Times
Time frame: Assessed at 2 weeks, 1 month, and 3 months post-surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared publicly due to several considerations. First, the data includes sensitive personal health information, which must be protected to comply with privacy regulations and ethical standards. Additionally, the study is conducted in a low-resource setting, where data management and sharing capabilities may be limited. Ensuring the confidentiality and anonymity of participants is paramount, and sharing IPD could compromise these ethical obligations. Finally, the data will be used exclusively for the purpose of this study to inform clinical practice within the context of the local healthcare system, rather than for broader dissemination.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Darn Vs. Lichtenstein Hernia Outcomes and Outcomes of Darn and Lichtenstein Hernia Repairs, run by Sudan Medical Specialization Board at 1 site in Sudan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sudan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complication Rates (time frame: Up to 3 months post-surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024.