Closed Suction Drain vs no Drain on Symptomatic Seroma Formation After Laparoscopic Inguinal Hernia Repair
SALHS
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2018
CompletedFirst Posted
Study publicly available on registry
June 20, 2018
CompletedStudy Start
First participant enrolled
August 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2019
CompletedOctober 14, 2020
October 1, 2020
1.1 years
May 28, 2018
October 12, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Month 3
Secondary Outcomes (3)
Surgical site infection
Month 3
Postoperative Pain
Day 1
Recurrence
Month 3
Other Outcomes (1)
Factors affecting seroma
Day 7
Study Arms (2)
Lap Inguinal Hernia repair with Drain
EXPERIMENTALA (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 COMPARATORNo drain will be placed after laparoscopic inguinal hernia (TEP/TAPP) surgery.
Interventions
Standardized minimally invasive approach to inguinal hernia repair
Eligibility Criteria
You may qualify if:
- All patients having an inguinoscrotal hernia (complete type)
You may not qualify if:
- Obstructed, incarcerated or strangulated hernia Patients unwilling to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sandeep C. Sabnis
Coimbatore, Tamil Nadu, 641015, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2018
First Posted
June 20, 2018
Study Start
August 1, 2018
Primary Completion
September 15, 2019
Study Completion
November 30, 2019
Last Updated
October 14, 2020
Record last verified: 2020-10