HerniaNCT06389331
Study on Effects of Defect Closure in Laparoscopic Repair of Direct Inguinal Hernia
An observational study of Hernia and Direct Inguinal Hernia, run by B.P. Koirala Institute of Health Sciences at 1 site in Nepal.
Trial summary
The defect closure was found to have higher pain and less seroma formation at various intervals of time following TEP for moderate-large direct inguinal hernia. Although these findings were statistically insignificant, they may be clinically significant, and further studies with a larger sample size are suggested. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hernia, Direct Inguinal Hernia, Seroma Following Procedure
- What is being tested?
- closed the defect with barbed suture
- How many people
- 88 participants
- Where
- 1 siteNepal
- Study dates
- 1 Sep 2020to 31 Aug 2021
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with inguinal hernia presenting to surgery OPD
Who may be able to join
- age greater than 18 years
- uncomplicated direct inguinal hernia (≥M3)
Who cannot join
- defect size ≤M2
- complicated hernia (irreducible, obstructed, or recurrent hernia)
- patients unfit for general anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study on Effects of Defect Closure Versus Non-Closure in Laparoscopic Totally Extraperitoneal Repair of Direct Inguinal Hernia
The defect closure was found to have higher pain and less seroma formation at various intervals of time following TEP for moderate-large direct inguinal hernia. Although these findings were statistically insignificant, they may be clinically significant, and further studies with a larger sample size are suggested.
Read the detailed description
Inguinal hernia is a common and widespread condition from which millions of people suffer. Repair of an inguinal hernia is one of the most frequently performed operations in general surgery. Totally extraperitoneal (TEP) and transabdominal preperitoneal (TAPP) repair are the principal techniques in laparoscopic hernia repair. Laparoscopic hernia repair is recommended for bilateral and recurrent inguinal hernias. It has also been recommended for patients with primary unilateral inguinal hernia, contingent on the availability of surgical expertise and resources, due to a lower incidence of post-operative pain and chronic pain.
Seroma formation is a frequent complication of laparoscopic mesh repair of moderate-large direct inguinal hernia defects. While rates of seroma formation have been reported to be as high as 10-30%. Several attempts have been made to reduce the incidence of seroma formation, such as tacking the transversalis fascia (TF) to the ramus of the pubis, closing the direct inguinal hernia defect via the endoloop technique, and filling the potential dead space with fibrin glue. However, there is a potential increase in the risk of infection and also a risk of chronic pubic bone pain from the tack staples or vasculo-nervous injury if fixing the TF to the abdominal wall, which would lead to extra discomfort for the patient. The closure of a direct hernia defect with a barbed suture not only closes the defect superficially but also exterminates the defect cavity; consequently, the incidence of seroma formation has been greatly reduced.
However, there is still controversial evidence regarding the choice of the two procedures in terms of reducing the rate of seroma formation and pain. Thus, it is ambiguous which surgical technique should be considered best to repair an inguinal hernia. In this study, we tried to evaluate the technical aspect of direct defect closure in laparoscopic TEP inguinal hernia repair and its effect on the primary outcomes in terms of seroma formation and pain at different time intervals, along with the secondary outcomes such as operative time, length of postoperative hospital stay, days to resume normal activities, recurrence, and intraoperative complications like injury to the vas, vessel, and visceral injury or peritoneal tear.
- Conditions
- Hernia, Direct Inguinal Hernia, Seroma Following Procedure
- Being tested
- closed the defect with barbed suture
- Keywords
- TEP, Direct Hernia Closure, Seroma Formation, Pain
- Medical subject headings
- Hernia, Hernia, Inguinal, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
closed the defect with barbed sutureOther
In direct hernia, content was reduced, and the fascia transversalis (pseudo sac) was pulled and incorporated into closure with a non-absorbable polypropylene barbed monofilament size-0 suture
| Study group | Role | What they receive |
|---|---|---|
| defect closure | the fascia transversalis (pseudo sac) was pulled and incorporated into closure with a non-absorbable polypropylene barbed monofilament size-0 suture Receives: Other: closed the defect with barbed suture | |
| non closure group | defect was left open |
What is being measured
The primary outcome is the main question the study is designed to answer.
seroma formation in defect closure group
After closing the defect, there is less seroma formation than in the defect non closure group
Measured: till 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start1 Sep 2020
- Primary completion30 Jun 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- B.P. Koirala Institute of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vijay Pratap Sah, B.P. Koirala Institute of Health Sciences
- Investigators
- Rakesh Kumar Gupta, MS, Principal investigator, B. P. Koirala institute of health science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06389331
- Sponsor's protocol ID
- IRC/1971/020
- Status last verified
- Aug 2024
- First submitted
- 24 Apr 2024
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rutkow IM, Robbins AW. Demographic, classificatory, and socioeconomic aspects of hernia repair in the United States. Surg Clin North Am. 1993 Jun;73(3):413-26. doi: 10.1016/s0039-6109(16)46027-5.
PubMed 8497793McKernan JB, Laws HL. Laparoscopic repair of inguinal hernias using a totally extraperitoneal prosthetic approach. Surg Endosc. 1993 Jan-Feb;7(1):26-8. doi: 10.1007/BF00591232.
PubMed 8424228Usmani F, Wijerathne S, Malik S, Yeo C, Rao J, Lomanto D. Effect of direct defect closure during laparoscopic inguinal hernia repair ("TEP/TAPP plus" technique) on post-operative outcomes. Hernia. 2020 Feb;24(1):167-171. doi: 10.1007/s10029-019-02036-1. Epub 2019 Sep 6.
PubMed 31493054Kockerling F, Bittner R, Adolf D, Fortelny R, Niebuhr H, Mayer F, Schug-Pass C. Seroma following transabdominal preperitoneal patch plasty (TAPP): incidence, risk factors, and preventive measures. Surg Endosc. 2018 May;32(5):2222-2231. doi: 10.1007/s00464-017-5912-3. Epub 2017 Oct 26.
PubMed 29075973
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study on Effects of Defect Closure Versus Non-Closure in Laparoscopic Totally Extraperitoneal Repair of Direct Inguinal Hernia
- ClinicalTrials.gov ID
- NCT06389331
- Acronym / sponsor ID
- IRC/1971/020
- Conditions
- Hernia, Direct Inguinal Hernia, Seroma Following Procedure
- Keywords
- TEP, Direct Hernia Closure, Seroma Formation, Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- B.P. Koirala Institute of Health SciencesUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 29 Apr 2024 (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 defect closure was found to have higher pain and less seroma formation at various intervals of time following TEP for moderate-large direct inguinal hernia. Although these findings were statistically insignificant, they may be clinically significant, and further studies with a larger sample size are suggested.
Detailed description
Inguinal hernia is a common and widespread condition from which millions of people suffer. Repair of an inguinal hernia is one of the most frequently performed operations in general surgery. Totally extraperitoneal (TEP) and transabdominal preperitoneal (TAPP) repair are the principal techniques in laparoscopic hernia repair. Laparoscopic hernia repair is recommended for bilateral and recurrent inguinal hernias. It has also been recommended for patients with primary unilateral inguinal hernia, contingent on the availability of surgical expertise and resources, due to a lower incidence of post-operative pain and chronic pain.
Seroma formation is a frequent complication of laparoscopic mesh repair of moderate-large direct inguinal hernia defects. While rates of seroma formation have been reported to be as high as 10-30%. Several attempts have been made to reduce the incidence of seroma formation, such as tacking the transversalis fascia (TF) to the ramus of the pubis, closing the direct inguinal hernia defect via the endoloop technique, and filling the potential dead space with fibrin glue. However, there is a potential increase in the risk of infection and also a risk of chronic pubic bone pain from the tack staples or vasculo-nervous injury if fixing the TF to the abdominal wall, which would lead to extra discomfort for the patient. The closure of a direct hernia defect with a barbed suture not only closes the defect superficially but also exterminates the defect cavity; consequently, the incidence of seroma formation has been greatly reduced.
However, there is still controversial evidence regarding the choice of the two procedures in terms of reducing the rate of seroma formation and pain. Thus, it is ambiguous which surgical technique should be considered best to repair an inguinal hernia. In this study, we tried to evaluate the technical aspect of direct defect closure in laparoscopic TEP inguinal hernia repair and its effect on the primary outcomes in terms of seroma formation and pain at different time intervals, along with the secondary outcomes such as operative time, length of postoperative hospital stay, days to resume normal activities, recurrence, and intraoperative complications like injury to the vas, vessel, and visceral injury or peritoneal tear.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| defect closure | – | Other: closed the defect with barbed suturethe fascia transversalis (pseudo sac) was pulled and incorporated into closure with a non-absorbable polypropylene barbed monofilament size-0 suture |
| non closure group | – | –defect was left open |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with inguinal hernia presenting to surgery OPD
Key inclusion criteria (2 listed)
- age greater than 18 years
- uncomplicated direct inguinal hernia (≥M3)
Key exclusion criteria (3 listed)
- defect size ≤M2
- complicated hernia (irreducible, obstructed, or recurrent hernia)
- patients unfit for general anesthesia
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 |
|---|---|---|
| closed the defect with barbed sutureIn direct hernia, content was reduced, and the fascia transversalis (pseudo sac) was pulled and incorporated into closure with a non-absorbable polypropylene barbed monofilament size-0 suture | Other | defect closure |
Primary outcome
seroma formation in defect closure group
Time frame: till 6 months
After closing the defect, there is less seroma formation than in the defect non closure group
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 13 Aug 2024.
- Background: PubMed 8497793Rutkow IM, Robbins AW. Demographic, classificatory, and socioeconomic aspects of hernia repair in the United States. Surg Clin North Am. 1993 Jun;73(3):413-26. doi: 10.1016/s0039-6109(16)46027-5.
- Background: PubMed 8424228McKernan JB, Laws HL. Laparoscopic repair of inguinal hernias using a totally extraperitoneal prosthetic approach. Surg Endosc. 1993 Jan-Feb;7(1):26-8. doi: 10.1007/BF00591232.
- Background: PubMed 31493054Usmani F, Wijerathne S, Malik S, Yeo C, Rao J, Lomanto D. Effect of direct defect closure during laparoscopic inguinal hernia repair ("TEP/TAPP plus" technique) on post-operative outcomes. Hernia. 2020 Feb;24(1):167-171. doi: 10.1007/s10029-019-02036-1. Epub 2019 Sep 6.
- Background: PubMed 29075973Kockerling F, Bittner R, Adolf D, Fortelny R, Niebuhr H, Mayer F, Schug-Pass C. Seroma following transabdominal preperitoneal patch plasty (TAPP): incidence, risk factors, and preventive measures. Surg Endosc. 2018 May;32(5):2222-2231. doi: 10.1007/s00464-017-5912-3. Epub 2017 Oct 26.
- 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. This study is not recruiting at the moment.
Rakesh Kumar Gupta, MS principal investigator
B. P. Koirala institute of health science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hernia and Direct Inguinal Hernia, run by B.P. Koirala Institute of Health Sciences at 1 site in Nepal.
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 2 inclusion and 3 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 13 Aug 2024. 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 Nepal. 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?
seroma formation in defect closure group (time frame: till 6 months). 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 NCT06389331, which also lists 4 linked publications.
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 13 Aug 2024.