search
Back to results

Non Absorbable Mesh Reinforcement of Midline Incision Closure in High Risk Patients, Onlay Versus Preperitoneal Position, a Comparative Clinical Trial

Primary Purpose

Midline Incisions, High Risk Patients, Mesh Reinforcement

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
midline mesh reinforcement
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Midline Incisions focused on measuring midline reinforcement, incisional hernia, mesh

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Obesity
  • Diabetes mellitus (DM),
  • Steroid therapy,
  • Liver diseases,
  • Renal diseases,
  • Cardiac diseases, Chest diseases ,
  • Malignancy,
  • Nutritional deficiency
  • Old age

Exclusion Criteria:

  • non risk factor
  • previous incisional hernia

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    preperitoneal mesh

    onlay mesh

    Arm Description

    patients underwent preperitoneal mesh mesh placement

    patients underwent preperitoneal mesh mesh placement

    Outcomes

    Primary Outcome Measures

    midline incisional hernia ,
    clinical and ultrasound examination of the abdomen for incisional hernia development

    Secondary Outcome Measures

    post operative complications
    hematoma , seroma, wound infection by clinical examination and\or ultrasound

    Full Information

    First Posted
    October 25, 2019
    Last Updated
    October 28, 2019
    Sponsor
    Zagazig University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04145908
    Brief Title
    Non Absorbable Mesh Reinforcement of Midline Incision Closure in High Risk Patients, Onlay Versus Preperitoneal Position, a Comparative Clinical Trial
    Official Title
    Non Absorbable Mesh Reinforcement of Midline Incision Closure in High Risk Patients, Onlay Versus Preperitoneal Position, a Comparative Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2016 (Actual)
    Primary Completion Date
    August 2019 (Actual)
    Study Completion Date
    August 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Zagazig University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    comparison between onlay and preperitoneal augmentation of mid line closure in high risk patients
    Detailed Description
    This study is a randomized comparative clinical trial, carried out in the period from July 2016 to August, 2019, on 47 high-risk patients who are liable to develop incisional hernia, after elective abdominal operations through midline incisions. High-risk patients means patients who had one or more of the factors that make them more liable to develop incisional hernia, as Obesity, Diabetes mellitus (DM), Steroid therapy, Liver diseases, Renal diseases, Cardiac diseases, Chest diseases , Malignancy, Nutritional deficiency and Old age. Institutional Review Board, the ethical committee approved the study, determined the number of the study patients, all patients were informed and consented. Randomization was carried out by assistant nurse using randomization computer program. The patients were randomly divided into two groups: Group I: wound closure is reinforced by onlay polypropylene mesh (24 patients) Group II: wound closure is reinforced by preperitoneal polypropylene mesh (23 patients). In both groups midline laparotomy was closed by non-absorbable continuous suture, 4\1 ratio reinforced with interrupted sutures every 4 bites. All patients were subjected to: full history taking and clinical examination, radiological and laboratory investigations and endoscopy if needed. SURGICAL TECHNIQUE In group I patients, after completion of the deemed surgery, the linea alba was closed as mentioned before, then the subcutaneous tissue was dissected of the anterior rectus sheath for 2 cm on both sides, then a polypropylene mesh strip 4 cm width and 4 cm longer than the wound length was applied and centered over the wound, fixed in the onlay position using prolene sutures 2\0. Suction drain is left in position, subcutaneous tissue and skin closed as per usual. In group II patients, a preperitoneal pocket is created at the time of opening the mid line figure, linea alba is incised separately from peritoneum to facilitate formation of preperitoneal pocket , at time of closure, the mesh was inserted in the preperitoneal space after peritoneal closure with Vicryl 3\0 sutures, the mesh is fixed to the peritoneum by 4 stitches in the 4 quadrants , and to linea alba during midline closure , suction drain was left in the preperitoneal space. Follow up Patients were followed up in outpatient clinic, (weekly for the first month then monthly for the first six months and lastly every 3 months for one year( in each visit they were carefully examined for any wound occurrences or hernia development, superficial probe ultrasonic examination of abdominal wall was done after 1 week and after 1 month. Demographic data, preoperative, operative and follow up data was collected tabulated and analyzed using SPSS 22 program package.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Midline Incisions, High Risk Patients, Mesh Reinforcement, Incisional Hernia
    Keywords
    midline reinforcement, incisional hernia, mesh

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    two groups one group for onlay mesh position the other for preperitoneal position
    Masking
    Participant
    Masking Description
    patient don't know the procedure
    Allocation
    Randomized
    Enrollment
    47 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    preperitoneal mesh
    Arm Type
    Active Comparator
    Arm Description
    patients underwent preperitoneal mesh mesh placement
    Arm Title
    onlay mesh
    Arm Type
    Active Comparator
    Arm Description
    patients underwent preperitoneal mesh mesh placement
    Intervention Type
    Procedure
    Intervention Name(s)
    midline mesh reinforcement
    Intervention Description
    augmentation of midline closure by nonabsorbsble mesh
    Primary Outcome Measure Information:
    Title
    midline incisional hernia ,
    Description
    clinical and ultrasound examination of the abdomen for incisional hernia development
    Time Frame
    weekly for one month , then monthly for 6 months then every 3 months later on till one year
    Secondary Outcome Measure Information:
    Title
    post operative complications
    Description
    hematoma , seroma, wound infection by clinical examination and\or ultrasound
    Time Frame
    (1st month post operative

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Obesity Diabetes mellitus (DM), Steroid therapy, Liver diseases, Renal diseases, Cardiac diseases, Chest diseases , Malignancy, Nutritional deficiency Old age Exclusion Criteria: non risk factor previous incisional hernia

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Non Absorbable Mesh Reinforcement of Midline Incision Closure in High Risk Patients, Onlay Versus Preperitoneal Position, a Comparative Clinical Trial

    We'll reach out to this number within 24 hrs