Clinical trial NCT01776775: The Effect of Postoperative Abdominal Binder to Improve Outcomes After Incisional Hernia Repair
Official title: The Effect of Postoperative Abdominal Binder to Reduce Seroma Formation and Improve Early Clinical Outcome After Incisional Hernia Repair.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Incisional Hernia
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2013-01-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.
* if a patient withdraws his inclusion consent

Primary outcomes:
measure: seroma formation
timeFrame: 30 days postoperatively
Secondary outcomes:
measure: postoperative pain
timeFrame: pain during the postoperative days 1-3, 7, and 30.
Other outcomes:
measure: Quality of life
timeFrame: on day 30 and 90 postoperatively
measure: postoperative complications, readmittance, and need for general practitioner visits
timeFrame: 30 days postoperatively
measure: Cosmetic result
timeFrame: 3 months postoperatively
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
Study officials:
affiliation: Hvidovre University Hospital
name: Thue Bisgaard, DMSc
role: STUDY_DIRECTOR
References: