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

Inguinal Hernia Without Obstruction or Gangrene Clinical Trial

— SALHS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03563092
• Other study ID #: GEMSALHS
• Status: Completed
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: November 30, 2019

Study information

• Verified date: October 2020
• Source: GEM Hospital & Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 30, 2019
• Est. primary completion date: September 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

All patients having an inguinoscrotal hernia (complete type)

Exclusion Criteria:

Obstructed, incarcerated or strangulated hernia Patients unwilling to participate

Related Conditions & MeSH terms

• Gangrene
• Hernia
• Hernia, Inguinal
• Inguinal Hernia Without Obstruction or Gangrene

Intervention

Procedure:
• Laparoscopic Inguinal Hernia (TEP/TAPP) Surgery
Standardized minimally invasive approach to inguinal hernia repair

Locations

Country	Name	City	State
India	Sandeep C. Sabnis	Coimbatore	Tamil Nadu

Sponsors (1)

Lead Sponsor	Collaborator
GEM Hospital & Research Center

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Factors affecting seroma	To study the various factors associated with seroma like patients demographics, surgeon related factors, etc.	Day 7
Primary	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.	Month 3
Secondary	Surgical site infection		Month 3
Secondary	Postoperative Pain	Measured by Visual Analogue Pain Scale	Day 1
Secondary	Recurrence	Early recurrence of Hernia	Month 3