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

Not Applicable

Completed

• Conditions: Inguinal Hernia Without Obstruction or Gangrene
• Interventions: Procedure: Laparoscopic Inguinal Hernia (TEP/TAPP) Surgery

• Registration Number: NCT03563092
• Lead Sponsor: GEM Hospital & Research Center

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.

Study Timeline

• Study First Submitted: 2018-05-28
• Study First Submitted QC: 2018-06-08
• Study First Posted: 2018-06-20
• Study Start: 2018-08-01
• Primary Completion: 2019-09-15
• Study Completion: 2019-11-30
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-12
• Last Update Posted: 2020-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

All patients having an inguinoscrotal hernia (complete type)

Exclusion Criteria

Obstructed, incarcerated or strangulated hernia Patients unwilling to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lap Inguinal Hernia repair without Drain	Laparoscopic Inguinal Hernia (TEP/TAPP) Surgery	No drain will be placed after laparoscopic inguinal hernia (TEP/TAPP) surgery.
Lap Inguinal Hernia repair with Drain	Laparoscopic Inguinal Hernia (TEP/TAPP) Surgery	A (14 French sizes) closed suction drain will be placed in preperitoneal space after laparoscopic inguinal hernia (TEP/TAPP) surgery.

Primary Outcome Measures

Name	Time	Method
Number of patients developing symptomatic seroma requiring intervention after surgery	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 Outcome Measures

Name	Time	Method
Recurrence	Month 3	Early recurrence of Hernia
Postoperative Pain	Day 1	Measured by Visual Analogue Pain Scale
Surgical site infection	Month 3

Trial Locations

Locations (1)

Sandeep C. Sabnis; 🇮🇳 Coimbatore, Tamil Nadu, India