DrainageNCT07681700
Effect of Drainage on the Incidence of Seroma After Laparoscopic Trans Abdominal Preperitoneal Inguinal Hernia Repair
A study testing Trans-abdominal preperitoneal repair + Drainage and Trans-abdominal preperitoneal repair in people with Drainage and Seroma, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of the study is to evaluate the effect of drainage on the incidence of seroma after laparoscopic transabdominal preperitoneal inguinal hernia repair. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Drainage, Seroma, Laparoscopic
- What is being tested?
- Trans-abdominal preperitoneal repair + Drainage and Trans-abdominal preperitoneal repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2024to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged from18 to 70 years.
- Both sexes.
- Patients were diagnosed with all types of inguinal hernia who are candidates for elective trans-abdominal Preperitoneal (TAPP) repair.
Who cannot join
- Previous history of pelvic or lower abdominal surgery.
- Coagulopathy.
- Any condition contraindicating laparoscopic surgery.
- Patients with complicated hernia (irreducible/incarcerated or obstructed/strangulated hernia).
- Active infections.
- Uncorrected medical comorbidities.
- Bilateral inguinal hernia either preoperative or intraoperative diagnosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Effect of Drainage on the Incidence of Seroma After Laparoscopic Trans Abdominal Preperitoneal Inguinal Hernia Repair
The aim of the study is to evaluate the effect of drainage on the incidence of seroma after laparoscopic transabdominal preperitoneal inguinal hernia repair.
Read the detailed description
Inguinal hernia repair is one of the most common surgical conditions encountered in primary care settings. Globally, around 20 million groin hernia repairs are performed each year. Surgical procedure is the gold standard treatment for inguinal hernia repair.
Laparoscopic hernioplasty is suitable for patients with inguinal hernia who can undergo general anesthesia, especially in cases like hernia recurrence after open repair, bilateral hernias, and simultaneous procedures like cholecystectomy.
Although open mesh repair has already demonstrated a low recurrence rate, laparoscopic mesh repair has become increasingly popular in recent years due to its benefits, including a better view of the groin anatomy, ease in addressing bilateral hernias, and superior cosmetic outcomes. The two most widely used laparoscopic mesh repair techniques are Totally Extra peritoneal (TEP) and Trans abdominal Preperitoneal (TAPP) repair, both of which are based on the myopectineal orifice theory. The key difference between TEP and TAPP lies in the method used to access the preperitoneal space.
- Being tested
- Trans-abdominal preperitoneal repair + Drainage, Trans-abdominal preperitoneal repair
- Medical subject headings
- Seroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans-abdominal preperitoneal repair + DrainageProcedure or surgery
Patients underwent the trans-abdominal preperitoneal (TAPP) repair technique with closed suction drain was placed through the lateral 5 mm port.
Trans-abdominal preperitoneal repairProcedure or surgery
Patients underwent the trans-abdominal preperitoneal (TAPP) repair technique but the drain wasn't applied.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Patients underwent the trans-abdominal preperitoneal (TAPP) repair technique with closed suction drain was placed through the lateral 5 mm port. Receives: Procedure: Trans-abdominal preperitoneal repair + Drainage |
| Group B | Experimental | Patients underwent the trans-abdominal preperitoneal (TAPP) repair technique but the drain wasn't applied. Receives: Procedure: Trans-abdominal preperitoneal repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of patients suffering from Seroma
Incidence of patients suffering from Seroma in each group after Transabdominal preperitoneal inguinal hernia repair.
Measured: 6 months post-procedure
Secondary outcomes (4)
Degree of pain
Pain was assessed using Visual Analogue Scale (VAS) in which the pain score is defined from 0 (no pain) to 10 (maximum pain) at rest and during activity recorded at similar intervals.
Measured: 24 hours post-procedure
Degree of patient satisfaction
Degree of patient satisfaction was assessed using 3-likert point scale where (1, Neutral; 2, Satisfied; 3, Very satisfied)
Measured: 24 hours post-procedure
Measurement of operative time
Measurement of operative time was done from skin incision to closure.
Measured: Till closure of the skin (Up to 60 minutes).
Incidence of recurrence
Incidence of recurrence of hernia was assessed during follow-up visits.
Measured: 6 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start1 Dec 2024
- Primary completion1 Oct 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DrainageStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Abdirashid Ahmed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07681700
- Sponsor's protocol ID
- MS-55-2025 (28-4-2025)
- Status last verified
- Jun 2026
- First submitted
- 27 Jun 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effect of Drainage on the Incidence of Seroma After Laparoscopic Trans Abdominal Preperitoneal Inguinal Hernia Repair
- ClinicalTrials.gov ID
- NCT07681700
- Acronym / sponsor ID
- MS-55-2025 (28-4-2025)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 2 Jul 2026 (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 the study is to evaluate the effect of drainage on the incidence of seroma after laparoscopic transabdominal preperitoneal inguinal hernia repair.
Detailed description
Inguinal hernia repair is one of the most common surgical conditions encountered in primary care settings. Globally, around 20 million groin hernia repairs are performed each year. Surgical procedure is the gold standard treatment for inguinal hernia repair.
Laparoscopic hernioplasty is suitable for patients with inguinal hernia who can undergo general anesthesia, especially in cases like hernia recurrence after open repair, bilateral hernias, and simultaneous procedures like cholecystectomy.
Although open mesh repair has already demonstrated a low recurrence rate, laparoscopic mesh repair has become increasingly popular in recent years due to its benefits, including a better view of the groin anatomy, ease in addressing bilateral hernias, and superior cosmetic outcomes. The two most widely used laparoscopic mesh repair techniques are Totally Extra peritoneal (TEP) and Trans abdominal Preperitoneal (TAPP) repair, both of which are based on the myopectineal orifice theory. The key difference between TEP and TAPP lies in the method used to access the preperitoneal space.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Trans-abdominal preperitoneal repair + DrainagePatients underwent the trans-abdominal preperitoneal (TAPP) repair technique with closed suction drain was placed through the lateral 5 mm port. |
| Group B | Experimental | Procedure: Trans-abdominal preperitoneal repairPatients underwent the trans-abdominal preperitoneal (TAPP) repair technique but the drain wasn't applied. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged from18 to 70 years.
- Both sexes.
- Patients were diagnosed with all types of inguinal hernia who are candidates for elective trans-abdominal Preperitoneal (TAPP) repair.
Key exclusion criteria (7 listed)
- Previous history of pelvic or lower abdominal surgery.
- Coagulopathy.
- Any condition contraindicating laparoscopic surgery.
- Patients with complicated hernia (irreducible/incarcerated or obstructed/strangulated hernia).
- Active infections.
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 |
|---|---|---|
| Trans-abdominal preperitoneal repair + DrainagePatients underwent the trans-abdominal preperitoneal (TAPP) repair technique with closed suction drain was placed through the lateral 5 mm port. | Procedure or surgery | Group A |
| Trans-abdominal preperitoneal repairPatients underwent the trans-abdominal preperitoneal (TAPP) repair technique but the drain wasn't applied. | Procedure or surgery | Group B |
Primary outcome
Incidence of patients suffering from Seroma
Time frame: 6 months post-procedure
Incidence of patients suffering from Seroma in each group after Transabdominal preperitoneal inguinal hernia repair.
4 secondary outcomes
Degree of pain
Time frame: 24 hours post-procedure
Degree of patient satisfaction
Time frame: 24 hours post-procedure
Measurement of operative time
Time frame: Till closure of the skin (Up to 60 minutes).
Incidence of recurrence
Time frame: 6 months post-procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trans-abdominal preperitoneal repair + Drainage and Trans-abdominal preperitoneal repair in people with Drainage and Seroma, run by Cairo University at 1 site in Egypt.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 2 Jul 2026. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of patients suffering from Seroma (time frame: 6 months post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jul 2026.