NCT02320071

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 19, 2014

Completed
13 days until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

September 3, 2015

Status Verified

September 1, 2015

Enrollment Period

1 year

First QC Date

December 16, 2014

Last Update Submit

September 2, 2015

Conditions

Hernia, Ventral

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (7)

  • Physical activity level

    Change at three months from baseline examination

  • Pain

    Change at three months from baseline examination

  • Discomfort

    Change at three months from baseline examination

  • Forced vital capacity

    Change at three months from baseline examination

  • Forced expiratorry volume for one second (FEV1)

    Change at three months from baseline examination

  • +2 more secondary outcomes

Study Arms (1)

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

Interventions

Examination of abdominal wall strength changes over timeOTHER
Patients with incisional hernia

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg Hospital

Copenhagen Northwest, Copenhagen, 2400, Denmark

RECRUITING

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Thue Bisgaard, MD, Dr. Msc.

    Gastrounit, Surgical Section, Hvidovre Hospital

    STUDY CHAIR

Central Study Contacts

Kristian Kiim Jensen, MD

CONTACT

+4535312201kristian.kiim.jensen@regionh.dk

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PHD student

Study Record Dates

First Submitted

December 16, 2014

First Posted

December 19, 2014

Study Start

January 1, 2015

Primary Completion

January 1, 2016

Study Completion

April 1, 2016

Last Updated

September 3, 2015

Record last verified: 2015-09

Locations

DK(1)