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Completed

NCT Number: NCT03563092

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

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.

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Key information

Conditions

Inguinal Hernia Without Obstruction or Gangrene Gangrene Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sandeep C. Sabnis

Coimbatore, Tamil Nadu, 641015, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All patients having an inguinoscrotal hernia (complete type)

Exclusion criteria

Obstructed, incarcerated or strangulated hernia Patients unwilling to participate

Treatment and study plan

Laparoscopic Inguinal Hernia (TEP/TAPP) Surgery

Procedure

Standardized minimally invasive approach to inguinal hernia repair

Primary outcomes

  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 outcomes

  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 outcomes

  1. Factors affecting seroma

    Time frame: Day 7

    To study the various factors associated with seroma like patients demographics, surgeon related factors, etc.

Sponsors and collaborators

Lead sponsor

GEM Hospital & Research Center

Other

Registry information

Acronym: SALHS

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 20, 2018
Registry last updated
Oct 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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