Completed

ABD- BINDERPostoperative Abdominal Binder in Reducing Seroma Formation and Pain After Ventral (Umbi/Epi) Hernia Repair.

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What is being tested

ETO garments

Device
Who is being recruted

Hernia+2

+ Pathological Conditions, Signs and Symptoms

+ Pathological Conditions, Anatomical

From 18 to 80 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: October 2012
See protocol details

Summary

Principal SponsorHvidovre University Hospital
Last updated: June 9, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2012

Actual date on which the first participant was enrolled.

Postoperative seroma formation is one of the most common complications after ventral hernia repair. Although some seromas may not have clinical impact postoperative seroma formation often causes pain and discomfort and may even compromise wound healing. Several interventional procedures have been investigated to reduce or avoid postoperative seroma formation such as removal of the hernia sac, VAC (vacuum-assisted closure) therapy, talcum application to the subcutaneous layer, suction etc., but results are conflicting and evidence is of poor quality. The use of postoperative abdominal binder is often recommended after ventral hernia repair to prevent seroma and diminish pain, but still with no scientific evidence. Randomized, controlled, multi-center, investigator-blinded study supplemented with blinded statistical analysis (see below). 56 patients (2 x 28, umbi/epi) Due to power calculations. An intention to treat analysis is done. Patients are randomized either to abdominal binder or no abdominal binder. The abdominal binder is worn from immediately after the operation and continuously for 7 days, night and day. The belts are standard elastic belts (ostomy belts) from "ETO garments©" with standard height of 22 cm. and five different sizes in width (S, M, L, XL, XXL- depending on waist measure). A fitting will be done before the operation by waist measurement according to the recommendation from the company. Patients are followed-up for 30 days with clinical follow-up at day 7 and 30.

Principal SponsorHvidovre University Hospital
Last updated: June 9, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

56 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

HerniaPathological Conditions, Signs and SymptomsPathological Conditions, AnatomicalHernia, AbdominalHernia, Ventral

Criteria

4 inclusion criteria required to participate
Elective, primary and recurrent laparoscopic trocar-site hernia

Elective, primary and recurrent laparoscopic umbilical and epigastric hernia repair with mesh reinforcement

Fascia defects 2-8 cm measured preoperatively by the surgeon at the out-patient clinic for umbi/epi

Patients between 18-80 years

8 exclusion criteria prevent from participating
Acute operation

Chronic pain syndrome

Decompensated liver cirrhosis (Child-Pugh B-C)

Expected low compliance (language problems, dementia and abuse etc.)

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
The abdominal binder is worn from immediately after the operation and continuously for 7 days, night and day. The belts are standard elastic belts (ostomy belts) from "ETO garments©" with standard height of 22 cm. and five different sizes in width (S, M, L, XL, XXL- depending on waist measure). A fitting will be done before the operation by waist measurement according to the recommendation from the company.

Group II

No Intervention
no abdominal binder

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Hvidovre Hospital

Hvidovre, DenmarkOpen Hvidovre Hospital in Google Maps
CompletedOne Study Center