Abdominal Wall Function and Quality of Life and Before and After Incisional Hernia Repair (QualiFunc)

Bispebjerg Hospital

Status: Unknown

Conditions: Hernia, Ventral

Treatments: Other: Examination of abdominal wall strength changes over time

Study type: Observational

Funder types: Other

Identifiers

NCT02320071

H-1-2014-118

Details and patient eligibility

About

The primary objective of the present study is to investigate a possible correlation between abdominal wall function and subjective measures of QoL before and after laparoscopic repair of small- to medium sized incisional hernia.

This prospective study includes 25 patients undergoing laparoscopic incisional hernia repair. Abdominal wall function is examined by determination of maximal truncal flexion and extension with a fixated pelvis using a Goodstrength dynamometer (Metitur Ltd., Jyväskylä, Finland). Subjective scores of QoL (HerQLes), pain (visual analogue scale) and physical activity (International Physical Activity Questionnaire) are assessed. Patients are examined before, one month after and three months after the operation. Furthermore, pulmonary function is examined preoperative and three months postoperative by standard spirometry (forved vital capacity, peak expiratory flow, forced expiratory volume in 1 second) as well as maximum in- and expiratory pressure is measured.

Enrollment: 25 estimated patients

Sex: All

Ages: 25 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Elective laparoscopic repair for one or more incisional hernias in the midline (at least 5 cm caudal to the xiphoid process and at least 5 cm cranial to the pubic bone), using a synthetic mesh
• Horizontal fascial defect between 3 and 8 cm
• Age between 25 and 75 years
• American Association of Anesthesiologist score between I and III
• Body mass index < 33 kg/m^2

Exclusion criteria

• Severe musculoskeletal, neurologic or cardiopulmonary disease preventing the patient from climbing stairs or shopping for groceries
• Existing stoma
• Postoperative complications requiring intervention

Trial design

25 participants in 1 patient group

Patients with incisional hernia

Description:

Patients with one or more incisional hernias, combined horizontal fascial defect 3-8 cm, planned for laparoscopic mesh repair. Patients are examined before and one and three months postoperative in regard to abdominal wall function, pain, discomfort, hernia-related quality of life and physical activity level.

Treatment:

Other: Examination of abdominal wall strength changes over time