Evaluating the impact of round ligament preservation in hernia repair for women
A Prospective Analysis of the Effects of Round Ligament Preservation and Division in Laparoscopic Transabdominal Preperitoneal Inguinal Hernia Repair in Women.
This study tests whether keeping or cutting a specific ligament during hernia surgery helps women recover better and feel more satisfied afterward.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 106 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Başakşehir Çam & Sakura City Hospital Government |
| Locations | 1 site (Istanbul, Başakşehir) |
| Trial ID | NCT06786702 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effects of preserving versus cutting the round ligament during laparoscopic Trans Abdominal Pre-Peritoneal (TAPP) hernia repair in female patients. It will compare postoperative outcomes such as pain, seroma, hematoma, uterine prolapse, recurrence rates, and quality of life between the two groups. The study focuses on women aged 18 to 70 with various types of hernias who are suitable for TAPP surgery. Participants will be monitored for their recovery and overall satisfaction post-surgery.
Who should consider this trial
Good fit: Ideal candidates are female patients aged 18 to 70 with inguinal, femoral, or obturator hernias indicated for TAPP surgery.
Not a fit: Patients with strangulated or incarcerated hernias, or those undergoing surgical techniques other than TAPP, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and quality of life for women undergoing hernia repair.
How similar studies have performed: While the preservation of the round ligament during hernia repair is a debated topic, this specific approach has not been extensively tested in prior studies, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Istanbul, Başakşehir
- Başakşehir Çam Sakura City Hospital — Istanbul, Başakşehir, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Muhammet M. Vural, M.D — Basakşehir Çam Sakura Şehir Hastanesi
- Study coordinator: Muhammet M. Vural, M.D
- Email: mvural2995@gmail.com
- Phone: 05413637585
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.