Inguinal HerniaNCT06786702
The Importance of Preserving the Round Ligament in the Repair of Inguinal Hernias in Women
A study testing Laparoscopic TAPP (Trans Abdominal Pre-Peritoneal) hernia repair: Round Ligament Preservation and Laparoscopic TAPP (Trans Abdominal Pre-Peritoneal) hernia repair: Round Ligament Cutting in people with Inguinal Hernia and Femoral Hernia, run by Muhammet Mustafa Vural at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Inguinal Hernia, Femoral Hernia, Obturator Hernia
- What is being tested?
- Laparoscopic TAPP (Trans Abdominal Pre-Peritoneal) hernia repair: Round Ligament Preservation and Laparoscopic TAPP (Trans Abdominal Pre-Peritoneal) hernia repair: Round Ligament Cutting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2024to 20 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Başakşehir Çam Sakura City Hospital
Istanbul, Başakşehir, 34480
Muhammet M. Vural, M.D, 5413637585, mvural2995@gmail.com
İdris Kurtuluş, Assoc. Prof., 05321707047, idriskurtulus@gmail.com
About this study
Official title: A Prospective Analysis of the Effects of Round Ligament Preservation and Division in Laparoscopic Transabdominal Preperitoneal Inguinal Hernia Repair in Women.
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.
Read the detailed description
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
- Inguinal Hernia, Femoral Hernia, Obturator Hernia
- Being tested
- Laparoscopic TAPP (Trans Abdominal Pre-Peritoneal) hernia repair: Round Ligament Preservation, Laparoscopic TAPP (Trans Abdominal Pre-Peritoneal) hernia repair: Round Ligament Cutting
- Medical subject headings
- Hernia, Inguinal, Hernia, Femoral, Hernia, Obturator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic TAPP (Trans Abdominal Pre-Peritoneal) hernia repair: Round Ligament PreservationProcedure or 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 CuttingProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Laparoscopic TAPP (Trans Abdominal Pre-Peritoneal) hernia repair: Round Ligament Cutting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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"
Measured: 1 years
Secondary outcomes (7)
Duration of Operation (in minutes)
Outcome Description:
The total duration of the surgical operation, measured in minutes, recorded during the operation.
Measured: Per-operation
Blood Loss During Operation (in milliliters)
Outcome Description:
The amount of blood loss recorded during the operation, measured in milliliters.
Measured: Per-operation
Number of Tackers Used During Operation
Outcome Description:
The total number of tackers used during the operation.
Measured: Per-operation
Mesh Size Used in Operation (in square centimeters)
Outcome Description:
The size of the mesh used during the operation, measured in square centimeters.
Measured: Per-operation
Pain Score at the Hernia Side (Using EuraHS-QoL)
Pain score assessed using the EuraHS-quality-of-life questionnaire, specific to the hernia side. The score reflects the level of pain experienced postoperatively.
Measured: 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)
Activity limitation due to pain or discomfort in the hernia area, assessed using the EuraHS-quality-of-life questionnaire
Measured: Measurements will be conducted on Day 1, at Month 3, and at Year 1
Cosmetic Discomfort Score (Using EuraHS-QoL)
Cosmetic discomfort related to the hernia area, assessed using the EuraHS-quality-of-life questionnaire. The score evaluates patient satisfaction with the cosmetic outcome
Measured: Measurements will be conducted on Day 1, at Month 3, and at Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start20 Apr 2024
- Primary completion30 Apr 2025 (estimated)
- Study completion20 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Muhammet Mustafa Vural
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Muhammet Mustafa Vural, Başakşehir Çam & Sakura City Hospital
- Investigators
- Muhammet M. Vural, M.D, Principal investigator, Basakşehir Çam Sakura Şehir Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06786702
- Sponsor's protocol ID
- BSH-GC-MMV-1
- Status last verified
- Jan 2025
- First submitted
- 18 Aug 2024
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35703818
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Analysis of the Effects of Round Ligament Preservation and Division in Laparoscopic Transabdominal Preperitoneal Inguinal Hernia Repair in Women.
- ClinicalTrials.gov ID
- NCT06786702
- Acronym / sponsor ID
- BSH-GC-MMV-1
- Conditions
- Inguinal Hernia, Femoral Hernia, Obturator Hernia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Muhammet Mustafa VuralOther government
- Study start
- 20 Apr 2024 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 20 Apr 2026 (estimated)
- First posted
- 22 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Round Ligament Preservation) | Active comparator | Procedure: Laparoscopic TAPP (Trans Abdominal Pre-Peritoneal) hernia repair: Round Ligament PreservationPatients 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) | Active comparator | Procedure: Laparoscopic TAPP (Trans Abdominal Pre-Peritoneal) hernia repair: Round Ligament CuttingPatients will undergo laparoscopic TAPP surgery with the round ligament cut close to the peritoneum using an energy device. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic TAPP (Trans Abdominal Pre-Peritoneal) hernia repair: Round Ligament PreservationGroup 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. | Procedure or surgery | Group 1 (Round Ligament Preservation) |
| Laparoscopic TAPP (Trans Abdominal Pre-Peritoneal) hernia repair: Round Ligament CuttingGroup 2 (Round Ligament Cutting): Patients will undergo laparoscopic TAPP surgery with the round ligament cut close to the peritoneum using an energy device. | Procedure or surgery | Group 2 (Round Ligament Cutting) |
Primary outcome
Postoperative Complication
Time frame: 1 years
"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"
7 secondary outcomes
Duration of Operation (in minutes)
Time frame: Per-operation
Blood Loss During Operation (in milliliters)
Time frame: Per-operation
Number of Tackers Used During Operation
Time frame: Per-operation
Mesh Size Used in Operation (in square centimeters)
Time frame: Per-operation
Pain Score at the Hernia Side (Using EuraHS-QoL)
Time frame: 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)
Time frame: Measurements will be conducted on Day 1, at Month 3, and at Year 1
Cosmetic Discomfort Score (Using EuraHS-QoL)
Time frame: Measurements will be conducted on Day 1, at Month 3, and at Year 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Results publication: PubMed 35703818Renshaw 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Muhammet M. Vural, M.D principal investigator
Basakşehir Çam Sakura Şehir Hastanesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic TAPP (Trans Abdominal Pre-Peritoneal) hernia repair: Round Ligament Preservation and Laparoscopic TAPP (Trans Abdominal Pre-Peritoneal) hernia repair: Round Ligament Cutting in people with Inguinal Hernia and Femoral Hernia, run by Muhammet Mustafa Vural at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muhammet M. Vural, M.D (05413637585, mvural2995@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Complication (time frame: 1 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06786702, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025; AzTrials last refreshed its copy on 8 Nov 2026.