Repair of Large Incisional Hernias - To Drain or Not to Drain Randomised Clinical Trial

NCT02163460 | Completed Phase 2 DMC

• 1 other identifier: 009/2011-CEP
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to perform a randomised clinical trial comparing the use of closed-suction tubular drains and progressive tension sutures in individuals with large incisional hernias subjected to onlay mesh repair to evaluate the occurrence of seroma and surgical wound infection after surgery.

Conditions

Ventral Hernia

Keywords

ventral hernia; seroma; drainage; infection

Outcome Measures

Primary Outcomes (1)

• Seroma

  Clinical and/or radiological diagnosis of seroma until 1 month

  1 month

Secondary Outcomes (1)

• Infection

  1 month

Other Outcomes (1)

• hernia recurrence

  1 year

Study Arms (2)

Drain

EXPERIMENTAL

In group 1(Drain), a 4.8 mm diameter continuous closed-suction tubular drain : was placed between the aponeurosis and the subcutaneous tissue caudally to the incision.

Procedure: Drain

Progressive Tension Sutures

EXPERIMENTAL

Drains were not used in group 2, but separate absorbable polyglactin 920 2/0 sutures were placed from the subcutaneous mesh to the aponeurosis every 2 cm by means of the progressive tension suture (or Quilting Sutures) technique, as described by Pollock et al

Procedure: Progressive Tension Sutures

Interventions

Drain PROCEDURE

In group 1, a 4.8 mm diameter continuous closed-suction tubular drain (Medsharp Ind.Com.Prod.Hosp.Ltda - reg. MS (Ministério da Saúde \[Health Ministry registry\]): 80267170001) was placed between the aponeurosis and the subcutaneous tissue caudally to the incision.

Also known as: 4.8 mm diameter surgical closed-suction tubular drain

Drain

Progressive Tension Sutures PROCEDURE

Drains were not used in group 2, but separate absorbable polyglactin 920 2/0 sutures were placed from the subcutaneous mesh to the aponeurosis every 2 cm by means of the progressive tension suture (or Quilting Sutures) technique, as described by Pollock et al

Also known as: Quilting Sutures, Baroudi Sutures

Progressive Tension Sutures

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals with primary or recurrent incisional hernia were assessed at HUOP, and those with longitudinal or transverse ventral hernia secondary to a previous surgical incision, measuring 5 to 15 cm after dissection of the hernial sac and classified as large or very large according to Chevrel's classification, were considered to be eligible.
• In individuals with multiple defects, the length between the cranial margin of the most cranial defect and the caudal margin of the most caudal defect was considered

You may not qualify if:

• Individuals subjected to emergency surgery, with infection
• Immunosuppressed
• Younger than 18 or older than 80 years old
• ASA III or IV, with a serum albumin concentration lower than 3.0 g/dl or who refused participation were excluded from the study

Sponsors & Collaborators

• Universidade Estadual do Oeste do Paraná: lead
• Federal University of São Paulo: collaborator

Study Sites (1)

Western Paraná State University / Universidade Estadual do Oeste do Paraná

Cascavel, Paraná, 85811-060, Brazil

Location

MeSH Terms

Conditions

Hernia, Ventral; Seroma; Infections

Interventions

Drainage

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Inflammation; Pathologic Processes

Intervention Hierarchy (Ancestors)

Therapeutics; Surgical Procedures, Operative

Study Officials

• Andre P Westphalen, MD

  Universidade Estadual do Oeste do Paraná

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2014
• First Posted: June 13, 2014
• Study Start: May 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2014
• Last Updated: June 13, 2014

Record last verified: 2014-06

Locations

BR (1)