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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-20

Study Completion Date

2026-04-20

Brief Summary

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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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Detailed Description

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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.

Conditions

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Inguinal Hernia Femoral Hernia Obturator Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study is a single-center, prospective investigation focusing on women with inguinal hernias. Patients will be divided into two groups based on the management of the round ligament during laparoscopic TAPP (Trans Abdominal Pre-Peritoneal) hernia repair:

Group 1: Patients in this group will have their round ligament preserved using different preservation techniques, specifically through a longitudinal incision technique in the peritoneum.

Group 2: Patients in this group will have their round ligament cut close to the peritoneum using an energy device for sealing.

Patients will be randomized into these groups, starting with the first patient assigned to Group 1. Each subsequent patient will be alternately assigned to the other group.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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.

Group 2 (Round Ligament Cutting)

Patients will undergo laparoscopic TAPP surgery with the round ligament cut close to the peritoneum using an energy device.

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No