NCT07337603

Brief 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. 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 2, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 13, 2026

Completed
Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

January 2, 2026

Last Update Submit

January 12, 2026

Conditions

Groin HerniaIntraocular Pressure

Keywords

TAPP procedureTEP procedureGroin HerniaIntraocular Pressure

Outcome Measures

Primary Outcomes (2)

  • TAPP procedure effects intraocular pressure

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

    Preooeratively and postoperative first day

  • TEP procedure effects intraocular pressure

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

    Preooeratively and postoperative first day

Study Arms (2)

TAPP Group

Planned groin hernia patients who will operated with Transabdominal Preperitoneal technique

Other: Preoperative Intraocular PressureOther: Postoperative Intraocular Pressure

TEP GRoup

Planned groin hernia patients who will operated with Trans Extra-Preperitoneal technique

Other: Preoperative Intraocular PressureOther: Postoperative Intraocular Pressure

Interventions

Preoperative Intraocular PressureOTHER

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

TAPP GroupTEP GRoup
Postoperative Intraocular PressureOTHER

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

TAPP GroupTEP GRoup

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Selecetive laparoscopic groin hernia repair patients

You may qualify if:

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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elazig Fethi Sekin City Hospital

Elâzığ, 23100, Turkey (Türkiye)

Location

Related Publications (13)

  • 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.

    PMID: 8921464BACKGROUND

  • 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.

    PMID: 9927978BACKGROUND

  • 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.

    PMID: 17263984BACKGROUND

  • 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.

    PMID: 22733195BACKGROUND

  • 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.

    PMID: 20546878BACKGROUND

  • 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.

    PMID: 29628557BACKGROUND

  • 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.

    PMID: 24064941BACKGROUND

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

    PMID: 21560974BACKGROUND

  • 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.

    PMID: 33427757RESULT

  • 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.

    PMID: 38963034RESULT

  • 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.

    PMID: 39077677RESULT

  • 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.

    PMID: 28490321RESULT

  • 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.

    PMID: 19608821RESULT

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Mehmet B Bozan, Professor

    Turkish Health Sciences University Elazig City Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Associate MD

Study Record Dates

First Submitted

January 2, 2026

First Posted

January 13, 2026

Study Start

July 1, 2025

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

January 14, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)