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

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.

Study Overview

• Status: Unknown
• Conditions: Hernia, Ventral
• Intervention / Treatment: Other: Examination of abdominal wall strength changes over time

• Study Type: Observational
• Enrollment (Anticipated): 25

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen
    • Copenhagen NW, Copenhagen, Denmark, 2400
      • Recruiting
      • Bispebjerg Hospital
      • Contact: Kristian Kiim Jensen, MD; Email: kristian.kiim.jensen@regionh.dk
      • Principal Investigator: Kristian Kiim Jensen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This prospective study includes 25 patients undergoing elective laparoscopic incisional hernia repair. Patients are included from Bispebjerg Hospital and Hvidovre Hospital, two university hospital surgical departments with unrestricted referral of patients.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with incisional hernia; 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.	Other: Examination of abdominal wall strength changes over time

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abdominal wall strength	Abdominal wall strength measured by Goodstrength Dynamometer before, one and three months after laparoscopic incisional hernia repair.	Change at three months from baseline examination
Hernia-related quality of life	Hernia-related quality of life (HerQLes) before, one and three months after laparoscopic incisional hernia repair.	Change at three months from baseline examination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical activity level	International Physical Activity Questionnaire (IPAQ) score before and three months after laparoscopic incisional hernia repair.	Change at three months from baseline examination
Pain	Pain on visual analogue scale (VAS) before and three months after laparoscopic incisional hernia repair.	Change at three months from baseline examination
Discomfort	Discomfort on visual analogue scale (VAS) before and three months after laparoscopic incisional hernia repair.	Change at three months from baseline examination
Forced vital capacity	Forced vital capacity measured by spirometry	Change at three months from baseline examination
Forced expiratorry volume for one second (FEV1)	Forced expiratorry volume for one second measured by spirometry	Change at three months from baseline examination
Maximal inspiratory pressure	Maximal inspiratory pressure measured by pressure monitor	Change at three months from baseline examination
Maximal expiratory pressure	Maximal inspiratory pressure measured by pressure monitor	Change at three months from baseline examination

Collaborators and Investigators

• Sponsor: Bispebjerg Hospital
• Collaborators: Hvidovre University Hospital
• Investigators: Study Chair: Thue Bisgaard, MD, Dr. Msc., Gastrounit, Surgical Section, Hvidovre Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): January 1, 2016
• Study Completion (Anticipated): April 1, 2016

Study Registration Dates

• First Submitted: December 16, 2014
• First Submitted That Met QC Criteria: December 16, 2014
• First Posted (Estimate): December 19, 2014

Study Record Updates

• Last Update Posted (Estimate): September 3, 2015
• Last Update Submitted That Met QC Criteria: September 2, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Ventral; Incisional Hernia
• Other Study ID Numbers: H-1-2014-118

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No