Inguinal Hernia Without Obstruction or GangreneSALHSNCT03563092
Closed Suction Drain vs no Drain on Symptomatic Seroma Formation After Laparoscopic Inguinal Hernia Repair
A study testing Laparoscopic Inguinal Hernia (TEP/TAPP) Surgery in people with Inguinal Hernia Without Obstruction or Gangrene, run by GEM Hospital & Research Center at 1 site in India.
Trial summary
The current study aims to determine whether a use of closed suction drain following laparoscopic inguinal hernia surgery performed for an inguinoscrotal variety can decrease the incidence of symptomatic seroma formation requiring interventions and thus, prevent postoperative morbidity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inguinal Hernia Without Obstruction or Gangrene
- What is being tested?
- Laparoscopic Inguinal Hernia (TEP/TAPP) Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- 1 Aug 2018to 30 Nov 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients having an inguinoscrotal hernia (complete type)
Who cannot join
- Obstructed, incarcerated or strangulated hernia Patients unwilling to participate
Trial locations and contacts
1 site in 1 country.
About this study
The current study aims to determine whether a use of closed suction drain following laparoscopic inguinal hernia surgery performed for an inguinoscrotal variety can decrease the incidence of symptomatic seroma formation requiring interventions and thus, prevent postoperative morbidity.
Read the detailed description
Patients with laparoscopic inguinal repair, TEP as well as TAPP approach, which matches the inclusion criteria will be randomized intraoperatively, based on a complete assessment of eligibility, just before the mesh placement.
Patients recruited in closed suction drain arm will receive suction drain(14 French sizes) in preperitoneal space via a separate incision. The patients without drain arm, the regular postoperative course will be followed.
The drain will be removed once the output falls below 50 ml per day. Both groups will be followed up until three months post-surgery.
Clinical suspicion of seroma in symptomatic patients will be confirmed by ultrasound. Seroma will be managed conservatively till three weeks in the post-op period.
- Being tested
- Laparoscopic Inguinal Hernia (TEP/TAPP) Surgery
- Keywords
- Complete Inguinal Hernia, Inguinoscrotal Hernia, Laparoscopic hernia repair
- Medical subject headings
- Gangrene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Inguinal Hernia (TEP/TAPP) SurgeryProcedure or surgery
Standardized minimally invasive approach to inguinal hernia repair
| Study group | Role | What they receive |
|---|---|---|
| Lap Inguinal Hernia repair with Drain | Experimental | A (14 French sizes) closed suction drain will be placed in preperitoneal space after laparoscopic inguinal hernia (TEP/TAPP) surgery. Receives: Procedure: Laparoscopic Inguinal Hernia (TEP/TAPP) Surgery |
| Lap Inguinal Hernia repair without Drain | Active comparator | No drain will be placed after laparoscopic inguinal hernia (TEP/TAPP) surgery. Receives: Procedure: Laparoscopic Inguinal Hernia (TEP/TAPP) Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients developing symptomatic seroma requiring intervention after surgery
The patients developing symptomatic seroma after hernia surgery, assessed by clinical and radiological evaluation, which needs intervention in form of needle aspiration or sac excision.
Measured: Month 3
Secondary outcomes (3)
Surgical site infection
Measured: Month 3
Postoperative Pain
Measured by Visual Analogue Pain Scale
Measured: Day 1
Recurrence
Early recurrence of Hernia
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2018
- Study start1 Aug 2018
- Primary completion15 Sep 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal Hernia Without Obstruction or GangreneStudies 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
- Open-label, randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- GEM Hospital & Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chinnusamy Palanivelu, MS,MCh,FRCS,FACS, Study chair, Gem Hospital and Research Center, Coimbatore, IndiaSandeep C. Sabnis, MS,DNB, Principal investigator, Gem Hospital and research center, Coimbatore, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03563092
- Sponsor's protocol ID
- GEMSALHS
- Acronym
- SALHS
- Status last verified
- Oct 2020
- First submitted
- 28 May 2018
- Last updated
- 14 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Closed Suction Drain vs no Drain on Symptomatic Seroma Formation After Laparoscopic Inguinal Hernia Repair
- ClinicalTrials.gov ID
- NCT03563092
- Acronym / sponsor ID
- SALHS / GEMSALHS
- Keywords
- Complete Inguinal Hernia, Inguinoscrotal Hernia, Laparoscopic hernia repair
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- GEM Hospital & Research CenterUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 15 Sep 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 20 Jun 2018 (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 current study aims to determine whether a use of closed suction drain following laparoscopic inguinal hernia surgery performed for an inguinoscrotal variety can decrease the incidence of symptomatic seroma formation requiring interventions and thus, prevent postoperative morbidity.
Detailed description
Patients with laparoscopic inguinal repair, TEP as well as TAPP approach, which matches the inclusion criteria will be randomized intraoperatively, based on a complete assessment of eligibility, just before the mesh placement.
Patients recruited in closed suction drain arm will receive suction drain(14 French sizes) in preperitoneal space via a separate incision. The patients without drain arm, the regular postoperative course will be followed.
The drain will be removed once the output falls below 50 ml per day. Both groups will be followed up until three months post-surgery.
Clinical suspicion of seroma in symptomatic patients will be confirmed by ultrasound. Seroma will be managed conservatively till three weeks in the post-op period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label, randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Lap Inguinal Hernia repair with Drain | Experimental | Procedure: Laparoscopic Inguinal Hernia (TEP/TAPP) SurgeryA (14 French sizes) closed suction drain will be placed in preperitoneal space after laparoscopic inguinal hernia (TEP/TAPP) surgery. |
| Lap Inguinal Hernia repair without Drain | Active comparator | Procedure: Laparoscopic Inguinal Hernia (TEP/TAPP) SurgeryNo drain will be placed after laparoscopic inguinal hernia (TEP/TAPP) surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients having an inguinoscrotal hernia (complete type)
Key exclusion criteria (1 listed)
- Obstructed, incarcerated or strangulated hernia Patients unwilling to participate
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 Inguinal Hernia (TEP/TAPP) SurgeryStandardized minimally invasive approach to inguinal hernia repair | Procedure or surgery | Lap Inguinal Hernia repair with Drain, Lap Inguinal Hernia repair without Drain |
Primary outcome
Number of patients developing symptomatic seroma requiring intervention after surgery
Time frame: Month 3
The patients developing symptomatic seroma after hernia surgery, assessed by clinical and radiological evaluation, which needs intervention in form of needle aspiration or sac excision.
3 secondary outcomes
Surgical site infection
Time frame: Month 3
Postoperative Pain
Time frame: Day 1
Recurrence
Time frame: Month 3
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 14 Oct 2020.
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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.
Chinnusamy Palanivelu, MS,MCh,FRCS,FACS study chair
Gem Hospital and Research Center, Coimbatore, India
Sandeep C. Sabnis, MS,DNB principal investigator
Gem Hospital and research center, Coimbatore, India
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 Inguinal Hernia (TEP/TAPP) Surgery in people with Inguinal Hernia Without Obstruction or Gangrene, run by GEM Hospital & Research Center at 1 site in India.
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 1 inclusion and 1 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 14 Oct 2020. 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 India. 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?
Number of patients developing symptomatic seroma requiring intervention after surgery (time frame: Month 3). 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 14 Oct 2020.