## Protocol Section
### Identification Module
**NCT ID:** NCT06417346

**Brief Title:** Comparison of Laparoscopic and Open Inguinal Hernia Repair in Elderly Patients

**Official Title:** Comparison of Laparoscopic and Open Inguinal Hernia Repair in Elderly Patients

#### Organization Study ID Info
**ID:** 65646564
#### Organization
**Class:** OTHER
**Full Name:** Konya City Hospital
### Status Module
#### Completion Date
**Date:** 2024-12-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-11

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-06-04

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-10-04

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-11
**Study First Submit QC Date:** 2024-05-11
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER_GOV

**Name:** Van Training and Research Hospital

#### Lead Sponsor

**Class:** OTHER

**Name:** Mehmet Eşref Ulutaş

#### Responsible Party

**Investigator Affiliation:** Konya City Hospital

**Investigator Full Name:** Mehmet Eşref Ulutaş

**Investigator Title:** Principal Investigator

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Inguinal hernia is one of the most frequently performed surgeries in general surgery. This surgery can be performed with both open and laparoscopic techniques. There is no clear consensus on whether inguinal hernia repair, which is one of the most frequently performed surgeries in elderly patients, should be performed open or laparoscopic. The application of the open technique with regional anesthesia methods such as spinal anesthesia and local anesthesia makes these methods attractive. The fact that laparoscopic techniques cause patients to recover faster also makes these techniques attractive. However, the fact that it is usually performed under general anesthesia is a significant disadvantage. Increasing comorbidities and increased drug use, especially in elderly patients, make surgeons think about which technique to prefer. The aim of this study is to compare open and laparoscopic inguinal hernia repair, which should be preferred in patients over 65 years of age.

### Conditions Module

**Conditions:**

- Urinary Retention

- Postoperative Complications

- Pain

- Relapse

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 160

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** A mini-incision was made at the umbilical margin, passing through the skin and subcutaneous tissue to expose the external sheath of the rectus muscle. The RS was incised, and the rectus muscle was laterally displaced. A 10-mm trocar was inserted into the preperitoneal space, and CO2 insufflation was performed with a pressure set at 12 mmHg. Two additional 5 mm trocars were inserted between the umbilicus and the symphysis pubis under laparoscopic guidance. Using laparoscopic dissectors and graspers, all steps of myopectineal orifice dissection were performed (16). A 15 × 10 cm prolene mesh was spread and secured to cover both direct and indirect hernia areas, extending approximately 2-3 cm beyond. Trocars were removed under camera surveillance after CO2 desufflation, and the skin was closed.

**Intervention Names:**

- Procedure: Laparoscopic TEP Repair

**Label:** Laparoscopic TEP Repair under General Anesthesia

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Following a classic inguinal incision of approximately 5-7 cm extending laterally from the pubic tubercle, the external oblique aponeurosis was opened, the external ring was disrupted, and the spermatic cord/round ligament was suspended. The hernia sac was isolated from surrounding tissues and the spermatic cord/round ligament, then either reduced or ligated. Subsequently, a polypropylene mesh measuring approximately 60x110 mm² was placed to completely cover the transverse fascia, and continuous sutures were used to secure it laterally along the transverse arch starting from the pubic tubercle. Hemostasis was achieved, and the layers and skin were anatomically closed.

**Intervention Names:**

- Procedure: Open Technique (Lichtenstein)

**Label:** Open Technique (Lichtenstein) under Spinal Anesthesia

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Laparoscopic TEP Repair under General Anesthesia

**Description:** Laparoscopic TEP Repair performed

**Name:** Laparoscopic TEP Repair

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Open Technique (Lichtenstein) under Spinal Anesthesia

**Description:** Open Technique (Lichtenstein) performed

**Name:** Open Technique (Lichtenstein)

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Measure:** rate of postoperative mortality

**Time Frame:** postoperative 24 hours

#### Secondary Outcomes

**Measure:** rate of urinary retansion

**Time Frame:** postoperative 24 hours

**Measure:** rate of postoperative pain

**Time Frame:** postoperative 24 hours

**Measure:** Rate of Hernia recurrence

**Time Frame:** first year

**Description:** such as wound infection, bleeding

**Measure:** Rate of Postoperative complications

**Time Frame:** postoperative 24 hours and 1st month

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients with inguinal hernias.
* Patients aged over 65.

Exclusion Criteria:

* Younger than 65 years.
* Incarcerated or strangulated inguinal hernias.

**Minimum Age:** 65 Years

**Sex:** ALL

**Standard Ages:**

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** drabdullahhilmi@gmail.com

**Name:** Abdullah Hilmi Yılmaz, MD

**Phone:** 0432 222 00 10

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Van

**Contacts:**

***Contact 1:***

- **Email:** drabdullahhilmi@gmail.com

- **Name:** Abdullah Hilmi Yılmaz, MD

- **Phone:** 0432 222 00 10

- **Role:** CONTACT

**Country:** Turkey

**Facility:** University of Health Science Van Training and Research Hospital

**Status:** RECRUITING

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Vigneswaran Y, Gitelis M, Lapin B, Denham W, Linn J, Carbray J, Ujiki M. Elderly and octogenarian cohort: Comparable outcomes with nonelderly cohort after open or laparoscopic inguinal hernia repairs. Surgery. 2015 Oct;158(4):1137-43; discussion 1143-4. doi: 10.1016/j.surg.2015.08.002. Epub 2015 Aug 20.

**PMID:** 26299283

**Citation:** Xi S, Chen Z, Lu Q, Liu C, Xu L, Lu C, Cheng R. Comparison of laparoscopic and open inguinal-hernia repair in elderly patients: the experience of two comprehensive medical centers over 10 years. Hernia. 2024 Apr 4. doi: 10.1007/s10029-024-03004-0. Online ahead of print.

**PMID:** 38573484

**Citation:** Bowling K, El-Badawy S, Massri E, Rait J, Atkinson J, Leong S, Stuart A, Srinivas G. Laparoscopic and open inguinal hernia repair: Patient reported outcomes in the elderly from a single centre - A prospective cohort study. Ann Med Surg (Lond). 2017 Aug 29;22:12-15. doi: 10.1016/j.amsu.2017.08.013. eCollection 2017 Oct.

**PMID:** 28878892

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006547

- Term: Hernia

- ID: D000020763

- Term: Pathological Conditions, Anatomical

- ID: D000010335

- Term: Pathologic Processes

- ID: D000046449

- Term: Hernia, Abdominal

- ID: D000014555

- Term: Urination Disorders

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

### Condition Browse Module - Browse Leaves

- ID: M14065

- Name: Postoperative Complications

- Relevance: HIGH

- As Found: Postoperative Complications

- ID: M9625

- Name: Hernia

- Relevance: LOW

- As Found: Unknown

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M18552

- Name: Urinary Retention

- Relevance: HIGH

- As Found: Urinary Retention

- ID: M9630

- Name: Hernia, Inguinal

- Relevance: HIGH

- As Found: Inguinal Hernia

- ID: M22519

- Name: Pathological Conditions, Anatomical

- Relevance: LOW

- As Found: Unknown

- ID: M25675

- Name: Hernia, Abdominal

- Relevance: LOW

- As Found: Unknown

- ID: M17305

- Name: Urination Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000016055

- Term: Urinary Retention

- ID: D000011183

- Term: Postoperative Complications

- ID: D000006552

- Term: Hernia, Inguinal

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Coag

- Name: Coagulants

### Intervention Browse Module - Browse Leaves

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M9576

- Name: Hemostatics

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
