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Идёт набор NCT06786702

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

Без фазы С лечением Inguinal Hernia Femoral Hernia Obturator Hernia

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Laparoscopic TAPP (Trans Abdominal Pre-Peritoneal) hernia repair: Round Ligament Preservation, Laparoscopic TAPP (Trans Abdominal Pre-Peritoneal) hernia repair: Round Ligament Cutting.
Кому может быть актуально
Состояния в реестре: Inguinal Hernia, Femoral Hernia, Obturator Hernia. Базовые параметры: 18 лет — 70 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Процедура 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.
  • Процедура 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.

Первичные конечные точки

  • Postoperative Complication [Срок оценки: 1 years]
Вторичные конечные точки (7)
  • Duration of Operation (in minutes) [Срок оценки: Per-operation]
  • Blood Loss During Operation (in milliliters) [Срок оценки: Per-operation]
  • Number of Tackers Used During Operation [Срок оценки: Per-operation]
  • Mesh Size Used in Operation (in square centimeters) [Срок оценки: Per-operation]
  • Pain Score at the Hernia Side (Using EuraHS-QoL) [Срок оценки: 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) [Срок оценки: Measurements will be conducted on Day 1, at Month 3, and at Year 1]
  • Cosmetic Discomfort Score (Using EuraHS-QoL) [Срок оценки: Measurements will be conducted on Day 1, at Month 3, and at Year 1]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Turkey (Türkiye) · 1 центр
  • Başakşehir Çam Sakura City Hospital — Istanbul

Публикации

  • Renshaw S, Collins C, Gupta A, Poulose B, Haisley KR. Round Ligament Management in Female Patients Undergoing Inguinal Hernia Repair: Should We Divide or Preserve? J Am Coll Surg. 2022 Jun 1;234(6):1193-1200. doi: 10.1097/XCS.0000000000000207. Epub 2022 Apr 8. PMID 35703818

Идентификаторы

NCT: NCT06786702 · BSH-GC-MMV-1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗