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

October 12, 2020 updated by: GEM Hospital & Research Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Tamil Nadu
      • Coimbatore, Tamil Nadu, India, 641015
        • Sandeep C. Sabnis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

All patients having an inguinoscrotal hernia (complete type)

Exclusion Criteria:

Obstructed, incarcerated or strangulated hernia Patients unwilling to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Month 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical site infection
Time Frame: Month 3
Month 3
Postoperative Pain
Time Frame: Day 1
Measured by Visual Analogue Pain Scale
Day 1
Recurrence
Time Frame: Month 3
Early recurrence of Hernia
Month 3

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Factors affecting seroma
Time Frame: Day 7
To study the various factors associated with seroma like patients demographics, surgeon related factors, etc.
Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GEM Hospital & Research Center

Investigators

  • 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2018

Primary Completion (ACTUAL)

September 15, 2019

Study Completion (ACTUAL)

November 30, 2019

Study Registration Dates

First Submitted

May 28, 2018

First Submitted That Met QC Criteria

June 8, 2018

First Posted (ACTUAL)

June 20, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 14, 2020

Last Update Submitted That Met QC Criteria

October 12, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GEMSALHS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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