The Effect of Postoperative Abdominal Binder to Improve Outcomes After Incisional Hernia Repair

NCT01776775 | Withdrawn

• 1 other identifier: INSAB
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative seroma formation is one of the most common complications after ventral hernia repair with mesh. Although some seromas may not have clinical impact postoperative seroma formation often causes pain and discomfort and may even compromise wound healing. Abdominal binders (also called trusses, girdle, ostomy belt, longuette or abdominal belt) (AB) are commonly used in abdominal and plastic surgery to prevent seroma formation and diminish pain and discomfort after operation. The primary aim of the present study is to investigate the effect of postoperative abdominal binders after laparoscopic incisional hernia repair on postoperative pain, discomfort and quality of life. Secondary, we register seroma formation. A randomized, controlled, investigator-blinded study supplemented with blinded statistical analysis. We include 60 (2x30) incisional hernia repairs. Patients are randomized either to abdominal binder or no abdominal binder (controls). The abdominal binder is worn from immediately after the operation and continuously for 7 days and nights. All patients have a standardized operation with standardized intra- and postoperative medication regimen. Endpoints measurements are clinically detectable seroma formation scored with seroma classification system buý S. Morales-Conde, pain scored with self-registrations with VAS, and quality of life scored with EQ-5D, recurrence and other complications are also registered. Patients are followed until 90 days after the operation.

Conditions

Incisional Hernia

Outcome Measures

Primary Outcomes (1)

• seroma formation

  clinically detectable seroma formation

  30 days postoperatively

Secondary Outcomes (1)

• postoperative pain

  pain during the postoperative days 1-3, 7, and 30.

Other Outcomes (3)

• Quality of life

  on day 30 and 90 postoperatively

• postoperative complications, readmittance, and need for general practitioner visits

  30 days postoperatively

• Cosmetic result

  3 months postoperatively

Study Arms (2)

abdominal binder

ACTIVE COMPARATOR

use of postoperative abdominal binder 30 days after the hernia repair

Device: Abdominal binder

No abdominal binder

NO INTERVENTION

No intervention

Interventions

Abdominal binder DEVICE

The abdominal binder is worn from immediately after the operation and continuously for 7 days and nights. The belts are standard abdominal binders (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 for all included patients before the operation by waist measurement according to the recommendation from the company (see below). When applied, the patients are advised to apply the belt in a lying position.

Also known as: ETO garments©, ostomy belt, trusses, girdle, longuette, abdominal belt

abdominal binder

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• elective, primary and recurrent laparoscopic and open incisional hernia repair hernia with mesh reinforcement
• fascia defects 6-20 cm measured preoperatively by the surgeon at the out-patient clinic
• patients between 18-80 years

You may not qualify if:

• expected low compliance (language problems, dementia and abuse etc.)
• fascia defects \>20 cm measured at the preoperative clinical examination.
• acute operation
• decompensated liver cirrhosis (Child-Pugh 3-4)
• patients with a stoma
• if a secondary operation is performed during the hernia repair procedure.

Sponsors & Collaborators

• Hvidovre University Hospital: lead

Study Sites (1)

Hvidovre University Hospital

Hvidovre, 2650, Denmark

Location

MeSH Terms

Conditions

Incisional Hernia

Interventions

Trusses

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Surgical Equipment; Equipment and Supplies

Study Officials

• Thue Bisgaard, DMSc

  Hvidovre University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D

Study Record Dates

• First Submitted: January 24, 2013
• First Posted: January 28, 2013
• Study Start: January 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: August 1, 2016
• Last Updated: August 16, 2016

Record last verified: 2016-08

Locations

DK (1)