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

NCT ID: NCT03563092

Last Updated: 2020-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2019-11-30

Brief Summary

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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

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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.

Conditions

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Inguinal Hernia Without Obstruction or Gangrene

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Open-label, randomized clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Laparoscopic Inguinal Hernia (TEP/TAPP) Surgery

Intervention Type PROCEDURE

Standardized minimally invasive approach to inguinal hernia repair

Lap Inguinal Hernia repair without Drain

No drain will be placed after laparoscopic inguinal hernia (TEP/TAPP) surgery.

Group Type ACTIVE_COMPARATOR

Laparoscopic Inguinal Hernia (TEP/TAPP) Surgery

Intervention Type PROCEDURE

Standardized minimally invasive approach to inguinal hernia repair

Interventions

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Laparoscopic Inguinal Hernia (TEP/TAPP) Surgery

Standardized minimally invasive approach to inguinal hernia repair

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

All patients having an inguinoscrotal hernia (complete type)

Exclusion Criteria

Obstructed, incarcerated or strangulated hernia Patients unwilling to participate
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GEM Hospital & Research Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chinnusamy Palanivelu, MS,MCh,FRCS,FACS

Role: STUDY_CHAIR

Gem Hospital and Research Center, Coimbatore, India

Sandeep C. Sabnis, MS,DNB

Role: PRINCIPAL_INVESTIGATOR

Gem Hospital and research center, Coimbatore, India

Locations

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Sandeep C. Sabnis

Coimbatore, Tamil Nadu, India

Site Status

Countries

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India

Other Identifiers

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GEMSALHS

Identifier Type: -

Identifier Source: org_study_id

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