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

G

GEM Hospital & Research Center

Status

Completed

Conditions

Inguinal Hernia Without Obstruction or Gangrene

Treatments

Procedure: Laparoscopic Inguinal Hernia (TEP/TAPP) Surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT03563092
GEMSALHS

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

All patients having an inguinoscrotal hernia (complete type)

Exclusion criteria

Obstructed, incarcerated or strangulated hernia Patients unwilling to participate

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

Lap Inguinal Hernia repair with Drain
Experimental group
Description:
A (14 French sizes) closed suction drain will be placed in preperitoneal space after laparoscopic inguinal hernia (TEP/TAPP) surgery.
Treatment:
Procedure: Laparoscopic Inguinal Hernia (TEP/TAPP) Surgery
Lap Inguinal Hernia repair without Drain
Active Comparator group
Description:
No drain will be placed after laparoscopic inguinal hernia (TEP/TAPP) surgery.
Treatment:
Procedure: Laparoscopic Inguinal Hernia (TEP/TAPP) Surgery

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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