The Importance of Preserving the Round Ligament in the Repair of Inguinal Hernias in Women

January 19, 2025 updated by: Muhammet Mustafa Vural

A Prospective Analysis of the Effects of Round Ligament Preservation and Division in Laparoscopic Transabdominal Preperitoneal Inguinal Hernia Repair in Women.

The aim of this study is to evaluate the impact of preserving or not preserving the round ligament during laparoscopic Trans Abdominal Pre-Peritoneal (TAPP) hernia repair on postoperative outcomes in female patients. Specifically, the study will compare outcomes such as postoperative pain, seroma, hematoma, prolapsus of uterina , recurrence rates, and quality of life between patients whose round ligament was preserved versus those whose ligament was cut.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Study Overview:

The aim of this study is to evaluate the impact of preserving or not preserving the round ligament during laparoscopic Trans Abdominal Pre-Peritoneal (TAPP) hernia repair on postoperative outcomes in female patients. Specifically, the study will compare outcomes such as postoperative pain, seroma, hematoma, prolapsus of uterina, recurrence rates, and quality of life between patients whose round ligament was preserved versus those whose ligament was cut.

Background:

In women, inguinal hernias are less common but can present as femoral, inguinal, or obturator hernias. Treatment usually involves surgical repair, which can be performed using open or laparoscopic techniques. Laparoscopic methods, especially TAPP and Total Extraperitoneal (TEP), are increasingly preferred due to their lower recurrence rates and other benefits compared to open surgery.

Advantages of Laparoscopic TAPP Surgery:

Small Incisions: Results in less risk of complications and cosmetic benefits. Bilateral Viewing: Allows visualization and treatment of both sides simultaneously.

Lower Infection Risk: Smaller incisions reduce the risk of infection. Faster Recovery: Less postoperative pain and quicker return to daily activities.

Reduced Recurrence: More effective in preventing recurrence, especially after an initial open surgery.

Round Ligament Considerations:

The round ligament connects the uterus to the labia majora and can be involved in the TAPP procedure. The debate centers on whether to preserve or cut the round ligament during surgery. Preservation can be technically challenging due to adhesions, but cutting the ligament might impact recurrence rates and patient outcomes negatively.

There is ongoing debate about whether to preserve or cut the round ligament during laparoscopic preperitoneal repair in female patients. Many surgeons express concerns that preserving the round ligament may increase the risk of hernia recurrence. A recent study encompassing 1,365 women who underwent various methods of inguinal hernia repair (open, laparoscopic, or robotic) found that in 868 cases (63.6%) , the round ligament was cut. This suggests that in practice, round ligament division is commonly performed during both open and laparoscopic procedures.

However, literature indicates that there are few studies with weak evidence suggesting that not preserving the round ligament may lead to issues such as pain, dyspareunia (pain during intercourse), organ prolapse, and decreased quality of life.

Study Objectives:

Compare Outcomes: Assess the effects of preserving versus cutting the round ligament on postoperative pain, hernia recurrence, and quality of life.

Prospective Analysis: Collect and analyze data prospectively to determine the optimal surgical approach.

Conclusion:

This study aims to provide insights into the optimal surgical technique for female inguinal hernia repair using TAPP, highlighting the importance of round ligament management and its impact on patient outcomes.

Study Type

Interventional

Enrollment (Estimated)

106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
    • Başakşehir
      • Istanbul, Başakşehir, Turkey, 34480
        • Recruiting
        • Basaksehir Cam Sakura City Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • For patients applying to the General Surgery Clinic of Basaksehir Cam Sakura City Hospital:
  • Age Range: Female patients aged between 18 and 70 years.
  • Type of Hernia: Patients with inguinal, direct or indirect, femoral, and obturator hernias.
  • Surgical Indication: Patients indicated for TAPP (Transabdominal Preperitoneal) surgery.
  • Consent: Patients who consent to participate in the study.
  • General Anesthesia: Patients who are suitable for general anesthesia.
  • Follow-up: Patients who attend follow-up appointments regularly.

Exclusion Criteria:

  • Age: Female patients under 18 years old or over 70 years old.
  • Surgical Technique: Patients who are operated on with techniques other than TAPP (e.g., TEP, conventional surgery).
  • Hernia Type: Patients with strangulated or incarcerated hernias.
  • Hernia Location: Patients with hernias outside the groin region.
  • Surgical Site: Surgeries performed in different clinics.
  • Gender: Male patients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1 (Round Ligament Preservation)
Patients will undergo laparoscopic TAPP surgery with the round ligament preserved. The preservation will be achieved using a longitudinal incision technique in the peritoneum.
Procedure: Laparoscopic TAPP (Trans Abdominal Pre-Peritoneal) hernia repair: Round Ligament Preservation
Group 1 (Round Ligament Preservation): Patients will undergo laparoscopic TAPP surgery with the round ligament preserved. The preservation will be achieved using a longitudinal incision technique in the peritoneum.
Active Comparator: Group 2 (Round Ligament Cutting)
Patients will undergo laparoscopic TAPP surgery with the round ligament cut close to the peritoneum using an energy device.
Procedure: Laparoscopic TAPP (Trans Abdominal Pre-Peritoneal) hernia repair: Round Ligament Cutting
Group 2 (Round Ligament Cutting): Patients will undergo laparoscopic TAPP surgery with the round ligament cut close to the peritoneum using an energy device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Complication
Time Frame: 1 years
"Number of Participants with Postoperative Complications : Seroma (in centimeters) , Hematoma (in centimeters) , Loss of Sensation on Neurological Examination , Prolapse (in centimeters) Numbness (reported in anamnesis), Tingling (reported in anamnesis), Urinary Retention (reported in anamnesis), Dyspareunia (reported in anamnesis) . Measured at Day 1, Month 3, and Year 1"
1 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Operation (in minutes)
Time Frame: Per-operation

Outcome Description:

The total duration of the surgical operation, measured in minutes, recorded during the operation.
Per-operation
Blood Loss During Operation (in milliliters)
Time Frame: Per-operation

Outcome Description:

The amount of blood loss recorded during the operation, measured in milliliters.
Per-operation
Number of Tackers Used During Operation
Time Frame: Per-operation

Outcome Description:

The total number of tackers used during the operation.
Per-operation
Mesh Size Used in Operation (in square centimeters)
Time Frame: Per-operation

Outcome Description:

The size of the mesh used during the operation, measured in square centimeters.
Per-operation
Pain Score at the Hernia Side (Using EuraHS-QoL)
Time Frame: Measurements will be conducted on Day 1, at Month 3, and at Year 1
Pain score assessed using the EuraHS-quality-of-life questionnaire, specific to the hernia side. The score reflects the level of pain experienced postoperatively.
Measurements will be conducted on Day 1, at Month 3, and at Year 1
Score for Activity Limitation Due to Pain or Discomfort (Using EuraHS-QoL)
Time Frame: Measurements will be conducted on Day 1, at Month 3, and at Year 1
Activity limitation due to pain or discomfort in the hernia area, assessed using the EuraHS-quality-of-life questionnaire
Measurements will be conducted on Day 1, at Month 3, and at Year 1
Cosmetic Discomfort Score (Using EuraHS-QoL)
Time Frame: Measurements will be conducted on Day 1, at Month 3, and at Year 1
Cosmetic discomfort related to the hernia area, assessed using the EuraHS-quality-of-life questionnaire. The score evaluates patient satisfaction with the cosmetic outcome
Measurements will be conducted on Day 1, at Month 3, and at Year 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Muhammet Mustafa Vural

Investigators

  • Principal Investigator: Muhammet M. Vural, M.D, Basakşehir Çam Sakura Şehir Hastanesi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2024

Primary Completion (Estimated)

April 30, 2025

Study Completion (Estimated)

April 20, 2026

Study Registration Dates

First Submitted

August 18, 2024

First Submitted That Met QC Criteria

January 19, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 19, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BSH-GC-MMV-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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