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

Primary Purpose

Inguinal Hernia Without Obstruction or Gangrene

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Laparoscopic Inguinal Hernia (TEP/TAPP) Surgery
Sponsored by
GEM Hospital & Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inguinal Hernia Without Obstruction or Gangrene focused on measuring Complete Inguinal Hernia, Inguinoscrotal Hernia, Laparoscopic hernia repair

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

All patients having an inguinoscrotal hernia (complete type)

Exclusion Criteria:

Obstructed, incarcerated or strangulated hernia Patients unwilling to participate

Sites / Locations

  • Sandeep C. Sabnis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lap Inguinal Hernia repair with Drain

Lap Inguinal Hernia repair without Drain

Arm Description

A (14 French sizes) closed suction drain will be placed in preperitoneal space after laparoscopic inguinal hernia (TEP/TAPP) surgery.

No drain will be placed after laparoscopic inguinal hernia (TEP/TAPP) surgery.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Surgical site infection
Postoperative Pain
Measured by Visual Analogue Pain Scale
Recurrence
Early recurrence of Hernia

Full Information

First Posted
May 28, 2018
Last Updated
October 12, 2020
Sponsor
GEM Hospital & Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT03563092
Brief Title
Closed Suction Drain vs no Drain on Symptomatic Seroma Formation After Laparoscopic Inguinal Hernia Repair
Acronym
SALHS
Official Title
Closed Suction Drain vs no Drain on Symptomatic Seroma Formation After Laparoscopic Inguinal Hernia Repair
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
September 15, 2019 (Actual)
Study Completion Date
November 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GEM Hospital & Research Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia Without Obstruction or Gangrene
Keywords
Complete Inguinal Hernia, Inguinoscrotal Hernia, Laparoscopic hernia repair

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Open-label, randomized clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lap Inguinal Hernia repair with Drain
Arm Type
Experimental
Arm Description
A (14 French sizes) closed suction drain will be placed in preperitoneal space after laparoscopic inguinal hernia (TEP/TAPP) surgery.
Arm Title
Lap Inguinal Hernia repair without Drain
Arm Type
Active Comparator
Arm Description
No drain will be placed after laparoscopic inguinal hernia (TEP/TAPP) surgery.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic Inguinal Hernia (TEP/TAPP) Surgery
Intervention Description
Standardized minimally invasive approach to inguinal hernia repair
Primary Outcome Measure Information:
Title
Number of patients developing symptomatic seroma requiring intervention after surgery
Description
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.
Time Frame
Month 3
Secondary Outcome Measure Information:
Title
Surgical site infection
Time Frame
Month 3
Title
Postoperative Pain
Description
Measured by Visual Analogue Pain Scale
Time Frame
Day 1
Title
Recurrence
Description
Early recurrence of Hernia
Time Frame
Month 3
Other Pre-specified Outcome Measures:
Title
Factors affecting seroma
Description
To study the various factors associated with seroma like patients demographics, surgeon related factors, etc.
Time Frame
Day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients having an inguinoscrotal hernia (complete type) Exclusion Criteria: Obstructed, incarcerated or strangulated hernia Patients unwilling to participate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chinnusamy Palanivelu, MS,MCh,FRCS,FACS
Organizational Affiliation
Gem Hospital and Research Center, Coimbatore, India
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sandeep C. Sabnis, MS,DNB
Organizational Affiliation
Gem Hospital and research center, Coimbatore, India
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sandeep C. Sabnis
City
Coimbatore
State/Province
Tamil Nadu
ZIP/Postal Code
641015
Country
India

12. IPD Sharing Statement

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

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