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Groin HerniaNCT07337603

Intraocular Pressure in Laparoscopic Inguinal Hernia Repair

An observational study of Groin Hernia and Intraocular Pressure, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Inguinal hernia is a common clinical condition, accounting for approximately 75% of abdominal wall hernias. The inguinal hernia surgery is one of the most common operations worldwide. The primary treatment for inguinal hernia is surgical options. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Groin Hernia, Intraocular Pressure
What is being tested?
Preoperative Intraocular Pressure and Postoperative Intraocular Pressure
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jul 2025to 1 Jan 2026
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Selecetive laparoscopic groin hernia repair patients

Who may be able to join

  • Being over 18 years of age
  • Having been diagnosed with inguinal hernia
  • Those wishing to participate in the study

Who cannot join

  • Patients under 18 years of age
  • Patients diagnosed with glaucoma
  • Patients with rheumatological diseases (rheumatoid arthritis, SLE, etc.)
  • Patients with chronic kidney and liver failure
  • Patients who have undergone corneal transplantation
  • Patients with malignancy
Show all 12Show fewer
  • Patients diagnosed with bilateral inguinal hernia
  • Patients with ocular trauma
  • Myopia or hyperopia exceeding three diopters
  • Patients using systemic steroids
  • Body Mass Index > 30 kg/m2
  • Those who do not wish to participate in the study

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Elazig Fethi Sekin City Hospital

    Elâzığ, 23100

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect Of Trans-Anbdominal Pre-Peritoneal (TAPP) And Total Extra-Peritoneal (TEP) Procedures on Intraocular Pressure in Laparoscopıc Inguinal Hernia Repair :A Procspective Cohort Study

Inguinal hernia is a common clinical condition, accounting for approximately 75% of abdominal wall hernias. The inguinal hernia surgery is one of the most common operations worldwide. The primary treatment for inguinal hernia is surgical options. In addition to the standard open surgical approach, the Lichtenstein technique, laparoscopic methods such as transabdominal preperitoneal (TAPP) and total extraperitoneal (TEP) approaches are currently the most commonly used surgical procedures.

Both methods result in less postoperative pain, seroma, chronic pain, hematoma, and wound infection compared to the Lichtenstein technique.

Read more

Many surgeons use the Trendelenburg position, approximately 30 to 45 degrees, when performing laparoscopic procedures. The advantage of the Trendelenburg position is that it allows for better visualization of the abdominal and pelvic organs and creates space for the operation. However, the Trendelenburg position also has some complications, such as increasing intraocular pressure. Also, in laparoscopic surgeries, pneumoperitoneum is created by introducing CO₂ gas into the abdomen. This increases intra-abdominal pressure, causing the diaphragm to be pushed upward and raising thoracic pressure. As a result, central venous pressure increases and intracranial venous return becomes difficult, which can lead to a temporary increase in intraocular pressure. Perioorbital swelling and venous congestion caused by prolonged surgery time and the position used can cause compartment syndrome in the orbital space and even lead to vision loss.

The current literature indicates that the increase in intra-abdominal pressure during laparoscopic surgery, the patient's position, and the surgery time can lead to an increase in intraocular pressure.

Read the detailed description

Inguinal hernia is a common clinical condition, accounting for approximately 75% of abdominal wall hernias. It is more common in men than women, affecting approximately 25% of men and 2% of women throughout their lifetime. Due to its frequent occurrence, inguinal hernia surgery is one of the most common operations worldwide. The incidence of inguinal hernia shows a bimodal distribution, with the highest incidence occurring around the age of 5 and over 70. Two-thirds of these hernias are indirect hernias.

Many previous studies have identified several risk factors in its etiology, including advanced age, male gender, smoking, family history, conditions causing intra-abdominal pressure, and collagen connective tissue diseases.

The most fundamental point in diagnosing inguinal hernia is physical examination. Physical examination is the easiest and most accurate way to diagnose the hernia. However, while most inguinal hernias are diagnosed by physical examination, radiological examination may be necessary in cases where the body structure prevents physical examination. Radiological methods include ultrasonography, computed tomography and rarely magnetic resonance imaging.

The primary treatment for inguinal hernia is surgical options. In addition to the standard open surgical approach, the Lichtenstein technique, laparoscopic methods such as transabdominal preperitoneal (TAPP) and total extraperitoneal (TEP) approaches are currently the most commonly used surgical procedures.

The most frequently used laparoscopic treatment methods worldwide are TAPP and TEP procedures. In both methods, mesh is placed in the preperitoneal space, but in the TAPP technique, it is necessary to enter the abdominal cavity to place the mesh. In the TEP procedure, all procedures are performed without opening the peritoneal wall and without entering the abdomen.

While it is debated whether one procedure is superior to the other, there are discussions about their relative advantages and disadvantages. The most important advantage of the TEP procedure is that it is performed without entering the abdominal cavity; its disadvantage is that the surgeon performing the operation has to work in a narrower area. The advantages of the TAPP procedure are that it is a simpler technique, has a wider working area, and is suitable for bilateral evaluation. The disadvantage is the higher risk of intra-abdominal organ injury and intra-abdominal adhesions.

Both methods result in less postoperative pain, seroma, chronic pain, hematoma, and wound infection compared to the Lichtenstein technique.

Many surgeons use the Trendelenburg position, approximately 30 to 45 degrees, when performing laparoscopic procedures. The advantage of the Trendelenburg position is that it allows for better visualization of the abdominal and pelvic organs and creates space for the operation. However, the Trendelenburg position also has some complications, such as increasing intraocular pressure.

Also, in laparoscopic surgeries, pneumoperitoneum is created by introducing CO₂ gas into the abdomen. This increases intra-abdominal pressure, causing the diaphragm to be pushed upward and raising thoracic pressure. As a result, central venous pressure increases and intracranial venous return becomes difficult, which can lead to a temporary increase in intraocular pressure.

When the patient is placed in a head-down position, this return becomes even more difficult, and intraocular venous pressure increases even more. Similarly, prolonged surgery time can lead to increased hypoventilation and hypercapnia, which can cause choroidal congestion and increase intraocular pressure.

Perioorbital swelling and venous congestion caused by prolonged surgery time and the position used can cause compartment syndrome in the orbital space and even lead to vision loss.

The current literature indicates that the increase in intra-abdominal pressure during laparoscopic surgery, the patient's position, and the surgery time can lead to an increase in intraocular pressure.

Being tested
Preoperative Intraocular Pressure, Postoperative Intraocular Pressure
Keywords
TAPP procedure, TEP procedure, Groin Hernia, Intraocular Pressure
Medical subject headings
Hernia, Inguinal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Preoperative Intraocular PressureOther

    Preoperative Intraocular Pressure measurement for both eyes with Goldmann applanation tonometry before surgery

  • Postoperative Intraocular PressureOther

    Postoperative first day's Intraocular Pressure measurement for both eyes with Goldmann applanation tonometry

Study groups in NCT07337603
Study groupRoleWhat they receive
TAPP GroupPlanned groin hernia patients who will operated with Transabdominal Preperitoneal technique
Receives: Other: Preoperative Intraocular Pressure; Other: Postoperative Intraocular Pressure
TEP GRoupPlanned groin hernia patients who will operated with Trans Extra-Preperitoneal technique
Receives: Other: Preoperative Intraocular Pressure; Other: Postoperative Intraocular Pressure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. TAPP procedure effects intraocular pressure

    Preooeratively and postoperatively measured intraocular pressure with Goldmann's aplanasyon tonometry

    Measured: Preooeratively and postoperative first day

  2. TEP procedure effects intraocular pressure

    Preooeratively and postoperatively measured intraocular pressure with Goldmann's aplanasyon tonometry

    Measured: Preooeratively and postoperative first day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2026
  2. Study start1 Jul 2025
  3. Primary completion1 Jan 2026
  4. Study completion1 Jan 2026

Resources

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
Prospective
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07337603
Sponsor's protocol ID
EFSCH-2
Status last verified
Jan 2026
First submitted
2 Jan 2026
Last updated
14 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Primatesta P, Goldacre MJ. Inguinal hernia repair: incidence of elective and emergency surgery, readmission and mortality. Int J Epidemiol. 1996 Aug;25(4):835-9. doi: 10.1093/ije/25.4.835.

    PubMed 8921464
  • Rutkow IM. Epidemiologic, economic, and sociologic aspects of hernia surgery in the United States in the 1990s. Surg Clin North Am. 1998 Dec;78(6):941-51, v-vi. doi: 10.1016/S0039-6109(05)70363-7.

    PubMed 9927978
  • Lau H, Fang C, Yuen WK, Patil NG. Risk factors for inguinal hernia in adult males: a case-control study. Surgery. 2007 Feb;141(2):262-6. doi: 10.1016/j.surg.2006.04.014. Epub 2006 Jul 31.

    PubMed 17263984
  • Robinson A, Light D, Kasim A, Nice C. A systematic review and meta-analysis of the role of radiology in the diagnosis of occult inguinal hernia. Surg Endosc. 2013 Jan;27(1):11-8. doi: 10.1007/s00464-012-2412-3. Epub 2012 Jun 26.

    PubMed 22733195
  • Akhavan A, Gainsburg DM, Stock JA. Complications associated with patient positioning in urologic surgery. Urology. 2010 Dec;76(6):1309-16. doi: 10.1016/j.urology.2010.02.060. Epub 2010 May 23.

    PubMed 20546878
  • Kaur G, Sharma M, Kalra P, Purohit S, Chauhan K. Intraocular Pressure Changes during Laparoscopic Surgery in Trendelenburg Position in Patients Anesthetized with Propofol-based Total Intravenous Anesthesia Compared to Sevoflurane Anesthesia: A Comparative Study. Anesth Essays Res. 2018 Jan-Mar;12(1):67-72. doi: 10.4103/aer.AER_177_17.

    PubMed 29628557
  • Hoshikawa Y, Tsutsumi N, Ohkoshi K, Serizawa S, Hamada M, Inagaki K, Tsuzuki K, Koshimizu J, Echizen N, Fujitani S, Takahashi O, Deshpande GA. The effect of steep Trendelenburg positioning on intraocular pressure and visual function during robotic-assisted radical prostatectomy. Br J Ophthalmol. 2014 Mar;98(3):305-8. doi: 10.1136/bjophthalmol-2013-303536. Epub 2013 Sep 24.

    PubMed 24064941
  • Molloy BL. Implications for postoperative visual loss: steep trendelenburg position and effects on intraocular pressure. AANA J. 2011 Apr;79(2):115-21.

    PubMed 21560974
  • Aiolfi A, Cavalli M, Ferraro SD, Manfredini L, Bonitta G, Bruni PG, Bona D, Campanelli G. Treatment of Inguinal Hernia: Systematic Review and Updated Network Meta-analysis of Randomized Controlled Trials. Ann Surg. 2021 Dec 1;274(6):954-961. doi: 10.1097/SLA.0000000000004735.

    PubMed 33427757
  • Andresen K, Rosenberg J. Transabdominal pre-peritoneal (TAPP) versus totally extraperitoneal (TEP) laparoscopic techniques for inguinal hernia repair. Cochrane Database Syst Rev. 2024 Jul 4;7(7):CD004703. doi: 10.1002/14651858.CD004703.pub3.

    PubMed 38963034
  • Iossa A, Traumueller Tamagnini G, De Angelis F, Micalizzi A, Lelli G, Cavallaro G. TEP or TAPP: who, when, and how? Front Surg. 2024 Jul 15;11:1352196. doi: 10.3389/fsurg.2024.1352196. eCollection 2024.

    PubMed 39077677
  • Scheuermann U, Niebisch S, Lyros O, Jansen-Winkeln B, Gockel I. Transabdominal Preperitoneal (TAPP) versus Lichtenstein operation for primary inguinal hernia repair - A systematic review and meta-analysis of randomized controlled trials. BMC Surg. 2017 May 10;17(1):55. doi: 10.1186/s12893-017-0253-7.

    PubMed 28490321
  • Awad H, Santilli S, Ohr M, Roth A, Yan W, Fernandez S, Roth S, Patel V. The effects of steep trendelenburg positioning on intraocular pressure during robotic radical prostatectomy. Anesth Analg. 2009 Aug;109(2):473-8. doi: 10.1213/ane.0b013e3181a9098f.

    PubMed 19608821

Questions about this trial

What is this clinical trial studying?

An observational study of Groin Hernia and Intraocular Pressure, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).

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 3 inclusion and 12 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 14 Jan 2026. 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 Turkey (Türkiye). 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?

TAPP procedure effects intraocular pressure (time frame: Preooeratively and postoperative first day). 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?

On the ClinicalTrials.gov record for NCT07337603, which also lists 13 linked publications.

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 14 Jan 2026.

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