Clinical trial NCT03296475: Intraoperative Biomechanics in Complex Abdominal Wall Reconstruction
Official title: A Study of the Intra-operative Biomechanics in Complex Abdominal Wall Reconstruction: Do Changes in Abdominal Biomechanics Correlate With Significant Changes in Lung Compliance and Respiratory Function?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ventral Hernia
Abdominal Wall Defect
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: University College London Hospitals
First posted: 2017-09-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single arm prospective cohort study
Primary purpose: BASIC_SCIENCE

Brief summary: Background: A detailed study of the biomechanical changes before and after abdominal wall reconstruction (AWR) has not been performed. Changes in abdominal wall tension and intra-abdominal pressure have physiological consequences on respiratory and cardiology function. AWR surgeons currently do not know if they are applying too much tension when re-aligning the abdominal wall muscles during AWR. Too much tension is likely to cause respiratory and cardiac post-operative complications. The investigators propose to study the perioperative changes in abdominal biomechanics and cardiorespiratory physiology after AWR. In addition, investigators will also analyze the pre-operative patient CT scan to see if there any CT predictors of post-operative cardiorespiratory complications and hernia recurrence. The researchers hypothesize that there is a threshold value or force at which ventral hernias are repaired 'too tight' subjecting the patient to the increased risk of recurrence and cardiorespiratory complications.

Method: An in depth biomechanical and physiological study of 18-22 participants with midline ventral hernias will be carried out. Ventral hernias at least 5cm in width and only those in which primary fascial closure have been achieved will be included. Any operative technique used to achieve primary fascial closure will be included. Biomechanical and physiological measurements will be taken at five separate stages during the course of the patients' abdominal wall reconstruction. The final lung function tests, taken six weeks post op, will be compared to the patients' pre-operative tests. Meticulous attention will be paid to the study protocol making sure that in each patient the measurements are all taken at the same time and under the same conditions.

Discussion: This full biomechanical and physiological work up will enable AWR surgeons to assess when an AWR patient is subjected to too much biomechanical and physiological stress. The abdominal wall tension and strain will be measured to see if this predicts post complications and hernia recurrence.


Eligibility criteria: Inclusion Criteria:

* Patients with midline hernia defects. Only patients with one or more midline defect will be included. For our study, we will define a midline hernia as herniation through the linea alba and with the rectus muscles falling either side of the hernia. The pre-operative CT scan will be used to study the hernia morphology and to see whether the patient fulfills these criteria.
* Patients undergoing primary or incisional ventral hernia repair, without formation of or closure of a stoma.
* Patients with either a maximal ventral hernia axial width of greater than 5cm or a loss of domain of greater then 20%, as measured on their pre-operative CT or MRI scan. The loss of domain will be measured using the patients' preoperative CT or MRI scan following the method of Tanaka et al.
* Patients aged ≥ 18 years old.
* Midline hernias closed in the midline with primary fascial closure with or without mesh augmentation. Any reconstruction technique can be used (e.g. anterior or posterior component separation) as long as primary fascial closure is achieved. The mesh may be placed in either the retro-rectus position (with or without a transverse abdominis release) or the onlay position.
* Participants who have a synthetic or bio-synthetic mesh implanted.
* Midline ventral hernias of VHWG grade 2 or 3. Clean and or Clean-contaminated wound classification.
* The participant is legally competent, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to take part and has duly signed the consent form.

Exclusion Criteria:

* Emergency/Redo surgery.
* Defects not in the midline. Patients with one or more defect not through the linea alba on the pre-operative CT scan.
* AWR for abdominal wall sarcoma, invasive intra-abdominal carcinoma or other malignant disease.
* Contaminated VHWG grade 4 hernias. Or Contaminated or Dirty wound according to the CDC wound classification system.
* Concomitant procedures such as bowel resection.
* The hernia requires a bridged repair.
* Individuals with co-morbid respiratory disease requiring oral corticosteroids or home oxygen therapy.
* Individuals who require the mesh to be placed in the intra-abdominal position.
* A patient with active peritonitis or an active mesh or subcutaneous infection.
* Individuals with a diagnosis of Crohn's disease.
* Individuals of American Society of Anesthesiology grade 4 or 5.
* Complete removal of an existing synthetic mesh (or biosynthetic mesh if not absorb) from a prior hernia repair in the same location is not possible.
* Participants with human immunodeficiency virus (HIV), known liver cirrhosis or alcohol abuse with a known relapse within 12 months.

Primary outcomes:
measure: Dynamic Lung Compliance (measured in ml/cmH2O)
timeFrame: Day 1. Both measurements will be taken on the participants first day of the study. (Study enrollment will take place on the day of the participants operation.
Secondary outcomes:
measure: Perioperative changes in Total Lung Capacity (Litres)
timeFrame: TLC will be measured on Day 1 and at 6 weeks, 12 months and 3 years after the patients operation.
measure: Perioperative changes in Force Expiratory Volume (Litres)
timeFrame: FEV1 will be measured on Day 1 and at 6 weeks, 12 months and 3 years after the patients operation.
measure: Perioperative changes in Tidal Volume (Litres)
timeFrame: VT will be measured on Day 1 and at 6 weeks, 12 months and 3 years after the patients operation.
measure: Perioperative changes in Residual Volume (Litres)
timeFrame: RV will be measured on Day 1 and at 6 weeks, 12 months and 3 years after the patients operation.
measure: Perioperative changes in Peak Expiratory Flow (Litres/min)
timeFrame: PEF will be measured on Day 1 and at 6 weeks, 12 months and 3 years after the patients operation.
measure: Perioperative changes in Dynamic Lung Compliance (ml/cmH2O)
timeFrame: LC will be measured on Day 1 and at 6 weeks, 12 months and 3 years after the patients operation.
measure: Abdominal wall closure force before abdominal wall closure (Newtons)
timeFrame: Day 1. These abdominal wall closure measurements will be taken during the participants operation on the first day of the study. i.e. after enrollment, which will take place on the day of their operation.
measure: Abdominal wall strain index (no units) (this is a strain index, change in transverse length (cm) / original transverse length of abdominal wall (cm))
timeFrame: Day 1. Defect width readings taken during the abdominal wall reconstruction operation
measure: Ventral hernia recurrence
timeFrame: At 1 year after the patients operation.
measure: Perioperative change in Intra-abdominal pressure (IAP) (mmHg)
timeFrame: Day 1. Readings taken during the abdominal wall reconstruction operation
measure: Perioperative change in cardiac output (CO) (L/min)
timeFrame: Day 1. Readings taken during the abdominal wall reconstruction operation
measure: Perioperative change in stroke volume (SV) (L)
timeFrame: Day 1. Readings taken during the abdominal wall reconstruction operation
measure: Perioperative change in positive-end expiratory pressure (PEEP) (cm/H2O)
timeFrame: Day 1. Readings taken during the abdominal wall reconstruction operation
measure: Perioperative change in fraction of inspired oxygen (fraction or as a per cent)
timeFrame: Day 1. Readings taken during the abdominal wall reconstruction operation
measure: Perioperative physiological changes in partial pressure of oxygen (pO2) (kPA)
timeFrame: Day 1. Readings taken during the abdominal wall reconstruction operation
measure: Rates of (a) intra-operative, (b) early post-operative (within 30 days of operation) and (c) late post-operative complications.
timeFrame: Up to 3 years after the patients operation.
measure: Ventral hernia recurrence
timeFrame: At 3 year after the patients operation.
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Univeristy College London
Study officials:
affiliation: Joint Research Office, University College London
name: Suzanne Emerton, BA
role: STUDY_DIRECTOR
References: