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NCT Number: NCT06786702

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

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Laparoscopic TAPP (Trans Abdominal Pre-Peritoneal) hernia repair: Round Ligament Preservation

Procedure

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.

Laparoscopic TAPP (Trans Abdominal Pre-Peritoneal) hernia repair: Round Ligament Cutting

Procedure

Group 2 (Round Ligament Cutting): Patients will undergo laparoscopic TAPP surgery with the round ligament cut close to the peritoneum using an energy device.

Primary outcomes

  1. 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"

Secondary outcomes

  1. 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.

  2. Blood Loss During Operation (in milliliters)

    Time frame: Per-operation

    Outcome Description:

    The amount of blood loss recorded during the operation, measured in milliliters.

  3. Number of Tackers Used During Operation

    Time frame: Per-operation

    Outcome Description:

    The total number of tackers used during the operation.

  4. 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.

  5. 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.

  6. 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

  7. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Muhammet M. Vural, M.D

CONTACT

[email protected]

05413637585

İdris Kurtuluş, Assoc.prof

CONTACT

[email protected]

05321707047

Sponsors and collaborators

Lead sponsor

Muhammet Mustafa Vural

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jan 22, 2025
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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