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Closed Suction Drain vs no Drain on Symptomatic Seroma Formation After Laparoscopic Inguinal Hernia Repair (SALHS)

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ClinicalTrials.gov Identifier: NCT03563092
Recruitment Status : Completed
First Posted : June 20, 2018
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
GEM Hospital & Research Center

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Inguinal Hernia Without Obstruction or Gangrene Procedure: Laparoscopic Inguinal Hernia (TEP/TAPP) Surgery Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Open-label, randomized clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Closed Suction Drain vs no Drain on Symptomatic Seroma Formation After Laparoscopic Inguinal Hernia Repair
Actual Study Start Date : August 1, 2018
Actual Primary Completion Date : September 15, 2019
Actual Study Completion Date : November 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arms and Interventions
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Arm Intervention/treatment
Experimental: Lap Inguinal Hernia repair with Drain
A (14 French sizes) closed suction drain will be placed in preperitoneal space after laparoscopic inguinal hernia (TEP/TAPP) surgery.
 Procedure: Laparoscopic Inguinal Hernia (TEP/TAPP) Surgery
Standardized minimally invasive approach to inguinal hernia repair
Active Comparator: Lap Inguinal Hernia repair without Drain
No drain will be placed after laparoscopic inguinal hernia (TEP/TAPP) surgery.
 Procedure: Laparoscopic Inguinal Hernia (TEP/TAPP) Surgery
Standardized minimally invasive approach to inguinal hernia repair


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Surgical site infection [ Time Frame: Month 3 ]
  2. Postoperative Pain [ Time Frame: Day 1 ]
    Measured by Visual Analogue Pain Scale

  3. Recurrence [ Time Frame: Month 3 ]
    Early recurrence of Hernia


Other Outcome Measures:
  1. Factors affecting seroma [ Time Frame: Day 7 ]
    To study the various factors associated with seroma like patients demographics, surgeon related factors, etc.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

All patients having an inguinoscrotal hernia (complete type)

Exclusion Criteria:

Obstructed, incarcerated or strangulated hernia Patients unwilling to participate

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03563092


Locations
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India
Sandeep C. Sabnis
Coimbatore, Tamil Nadu, India, 641015
Sponsors and Collaborators
GEM Hospital & Research Center
Investigators
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Study Chair: Chinnusamy Palanivelu, MS,MCh,FRCS,FACS Gem Hospital and Research Center, Coimbatore, India
Principal Investigator: Sandeep C. Sabnis, MS,DNB Gem Hospital and research center, Coimbatore, India
More Information
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Responsible Party: GEM Hospital & Research Center
ClinicalTrials.gov Identifier: NCT03563092    
Other Study ID Numbers: GEMSALHS
First Posted: June 20, 2018    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GEM Hospital & Research Center:
Complete Inguinal Hernia
Inguinoscrotal Hernia
Laparoscopic hernia repair
Additional relevant MeSH terms:
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Hernia
Hernia, Inguinal
Gangrene
Pathological Conditions, Anatomical
 Hernia, Abdominal
Pathologic Processes
Necrosis