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

NCT06786702 | Recruiting

• 1 other identifier: BSH-GC-MMV-1
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Inguinal Hernia; Femoral Hernia; Obturator Hernia

Outcome Measures

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"

  1 years

Secondary Outcomes (7)

• Duration of Operation (in minutes)

  Per-operation

• Blood Loss During Operation (in milliliters)

  Per-operation

• Number of Tackers Used During Operation

  Per-operation

• Mesh Size Used in Operation (in square centimeters)

  Per-operation

• Pain Score at the Hernia Side (Using EuraHS-QoL)

  Measurements will be conducted on Day 1, at Month 3, and at Year 1

Study Arms (2)

Group 1 (Round Ligament Preservation)

ACTIVE COMPARATOR

Patients will undergo laparoscopic TAPP surgery with the round ligament preserved. The preservation will be achieved using a longitudinal incision technique in the peritoneum.

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

Group 2 (Round Ligament Cutting)

ACTIVE COMPARATOR

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

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

Interventions

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.

Group 1 (Round Ligament Preservation)

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.

Group 2 (Round Ligament Cutting)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Muhammet Mustafa Vural: lead

Study Sites (1)

Başakşehir Çam Sakura City Hospital

Istanbul, Başakşehir, 34480, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Hernia, Inguinal; Hernia, Femoral; Hernia, Obturator

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Muhammet M. Vural, M.D

  Basakşehir Çam Sakura Şehir Hastanesi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammet M. Vural, M.D

CONTACT

05413637585; mvural2995@gmail.com

İdris Kurtuluş, Assoc.prof

CONTACT

05321707047; idriskurtulus@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assistant doctor

Model Details: 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.

Study Record Dates

• First Submitted: August 18, 2024
• First Posted: January 22, 2025
• Study Start: April 20, 2024
• Primary Completion: April 30, 2025
• Study Completion: April 20, 2026
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)