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

NCT ID: NCT02320071

Last Updated: 2015-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hernia, Ventral

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Examination of abdominal wall strength changes over time

Intervention Type OTHER

Interventions

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Examination of abdominal wall strength changes over time

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hvidovre University Hospital

OTHER

Sponsor Role collaborator

Bispebjerg Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kristian Kiim Jensen

MD, PHD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thue Bisgaard, MD, Dr. Msc.

Role: STUDY_CHAIR

Gastrounit, Surgical Section, Hvidovre Hospital

Locations

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Bispebjerg Hospital

Copenhagen Northwest, Copenhagen, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Kristian Kiim Jensen, MD

Role: CONTACT

+4535312201

Facility Contacts

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Kristian Kiim Jensen, MD

Role: primary

Other Identifiers

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H-1-2014-118

Identifier Type: -

Identifier Source: org_study_id

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