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

ConditionsInguinal HerniaFemoral HerniaObturator Hernia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorMuhammet Mustafa Vural

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Procedure/Surgery

    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/Surgery

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

Treatment groups

106 Participants
are divided into 2 treatment groups
Group A: Group 1 (Round Ligament Preservation)Active comparator 1 intervention
Group B: Group 2 (Round Ligament Cutting)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Postoperative Complication

"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"

Time frame
1 years

Secondary outcomes

1

Duration of Operation (in minutes)

Outcome Description: The total duration of the surgical operation, measured in minutes, recorded during the operation.

Time frame
Per-operation
2

Blood Loss During Operation (in milliliters)

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

Time frame
Per-operation
3

Number of Tackers Used During Operation

Outcome Description: The total number of tackers used during the operation.

Time frame
Per-operation
4

Mesh Size Used in Operation (in square centimeters)

Outcome Description: The size of the mesh used during the operation, measured in square centimeters.

Time frame
Per-operation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Muhammet Mustafa Vural

Lead sponsor

Başakşehir Çam & Sakura City Hospital

Sponsor institution

Source ClinicalTrials.gov
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