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Small Bite Technique Versus Standardised Large Bites Technique in Closure of Midline Laparotomies. (SBT-CML)

Primary Purpose

Incision, Surgical, Suture, Complication, Incisional Hernia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Small bite suturing Technique
Standardised Large Bites Technique
Sponsored by
Imam Abdulrahman Bin Faisal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Incision, Surgical

Eligibility Criteria

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

Inclusion Criteria:

  1. Laparotomy through a midline incision
  2. Age more than 18
  3. BMI < 40

Exclusion Criteria:

  1. Previous incisional hernia or fascial dehiscence with secondary healing after a midline incision.
  2. Abdominal surgery through a midline incision within the last three months.
  3. Pregnancy.
  4. Patient on steroids and with genetic anomalies.
  5. Malignancy patients, next exposed to radiation therapy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Other

    Arm Label

    Small Bite Technique Group

    Standardised Large Bites Technique Group

    Arm Description

    closure of laparotomy by small bites technique using PDS 2.0

    usual practice closure of laparotomy by standardised large bites technique using PDS 2.0

    Outcomes

    Primary Outcome Measures

    Incidence of Incisional Hernia postoperative
    Incidence of Incisional Hernia postoperative, will be assessed by using Ultra Sound.
    Incidence of Incisional Hernia postoperative
    Incidence of Incisional Hernia postoperative, will be assessed by using Ultra Sound.
    Assessment of pain severity postoperative by pain scale
    Assessment of pain scale post operative, lower score mean a better outcome.
    Assessment of pain severity postoperative by pain scale
    Assessment of pain scale post operative, lower score mean a better outcome.
    Assessment of pain severity postoperative by pain scale
    Assessment of pain scale post operative, lower score mean a better outcome.
    Assessment of pain severity postoperative by pain scale
    Assessment of pain scale post operative, lower score mean a better outcome.
    Assessment of pain severity postoperative by pain scale
    Assessment of pain scale post operative, lower score mean a better outcome.
    Assessment of pain severity postoperative by pain scale
    Assessment of pain scale post operative, lower score mean a better outcome.
    Assessment of pain severity postoperative by pain scale
    Assessment of pain scale post operative, lower score mean a better outcome.
    Assessment of pain severity postoperative by pain scale
    Assessment of pain scale post operative, lower score mean a better outcome.
    Assessment of pain severity postoperative by pain scale
    Assessment of pain scale post operative, lower score mean a better outcome.
    Assessment of pain severity postoperative by pain scale
    Assessment of pain scale post operative, lower score mean a better outcome.
    Assessment of pain severity postoperative by pain scale
    Assessment of pain scale post operative, lower score mean a better outcome.
    Assessment of pain severity postoperative by pain scale
    Assessment of pain scale post operative, lower score mean a better outcome.
    Assessment of pain severity postoperative by pain scale
    Assessment of pain scale post operative, lower score mean a better outcome.
    Assessment of pain severity postoperative by pain scale
    Assessment of pain scale post operative, lower score mean a better outcome.

    Secondary Outcome Measures

    Assessment of early mobilisation
    When the patient started to mobilise? assessed by monitoring the patients postoperative and record when he started to mobilise.
    Assessment of early mobilisation
    When the patient started to mobilise? assessed by monitoring the patients postoperative and record when he started to mobilise.
    Assessment of early mobilisation
    When the patient started to mobilise? assessed by monitoring the patients postoperative and record when he started to mobilise.
    Retain to work (how many days between surgery and patient back to his work)
    When the patient back to his work or usual activity? assessed by monitoring the patients postoperative and record when he started to work again.
    Surgical site infection of the wound postoperative
    Surgical site infection of the wound postoperative, if there is any sign of surgical site infection, itching, discharge, redness, fever, collection.
    Surgical site infection of the wound postoperative
    Surgical site infection of the wound postoperative, if there is any sign of surgical site infection, itching, discharge, redness, fever, collection.
    Surgical site infection of the wound postoperative
    Surgical site infection of the wound postoperative, if there is any sign of surgical site infection, itching, discharge, redness, fever, collection.
    Surgical site infection of the wound postoperative
    Surgical site infection of the wound postoperative, if there is any sign of surgical site infection, itching, discharge, redness, fever, collection.
    Surgical site infection of the wound postoperative
    Surgical site infection of the wound postoperative, if there is any sign of surgical site infection, itching, discharge, redness, fever, collection.
    Surgical site infection of the wound postoperative
    Surgical site infection of the wound postoperative, if there is any sign of surgical site infection, itching, discharge, redness, fever, collection.
    Surgical site infection of the wound postoperative
    Surgical site infection of the wound postoperative, if there is any sign of surgical site infection, itching, discharge, redness, fever, collection.
    Surgical site infection of the wound postoperative
    Surgical site infection of the wound postoperative, if there is any sign of surgical site infection, itching, discharge, redness, fever, collection.
    Surgical site infection of the wound postoperative
    Surgical site infection of the wound postoperative, if there is any sign of surgical site infection, itching, discharge, redness, fever, collection.
    Surgical site infection of the wound postoperative
    Surgical site infection of the wound postoperative, if there is any sign of surgical site infection, itching, discharge, redness, fever, collection.
    Surgical site infection of the wound postoperative
    Surgical site infection of the wound postoperative, if there is any sign of surgical site infection, itching, discharge, redness, fever, collection.
    Surgical site infection of the wound postoperative
    Surgical site infection of the wound postoperative, if there is any sign of surgical site infection, itching, discharge, redness, fever, collection.
    Surgical site infection of the wound postoperative
    Surgical site infection of the wound postoperative, if there is any sign of surgical site infection, itching, discharge, redness, fever, collection.
    Surgical site infection of the wound postoperative
    Surgical site infection of the wound postoperative, if there is any sign of surgical site infection, itching, discharge, redness, fever, collection.
    Time taken in closure of laparotomy incision (in minutes)
    Time taken for closure of the laparotomy incision, there will be timer, started from the beginning of suturing the laparotomy incision till the end. (in minutes)

    Full Information

    First Posted
    February 9, 2021
    Last Updated
    October 31, 2021
    Sponsor
    Imam Abdulrahman Bin Faisal University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04788875
    Brief Title
    Small Bite Technique Versus Standardised Large Bites Technique in Closure of Midline Laparotomies.
    Acronym
    SBT-CML
    Official Title
    Small Bite Technique Versus Standardised Large Bites Technique in Closure of Midline Laparotomies: Randomised Control Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2021 (Anticipated)
    Primary Completion Date
    November 30, 2023 (Anticipated)
    Study Completion Date
    November 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Imam Abdulrahman Bin Faisal University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    In the attempt to gain quick and complete access to the abdominal regions with the least damage to the nerves and the vascular structures, surgeons use the median laparotomy more frequently. However, postoperative complications such as incisional hernia continue to be the known leading complications after median laparotomy. The reported cases to range from 2 to 20%. Higher cases have also been reported with up to 35% in the absence and aortic patients. Recent statistics have showed that small tissue bites prevent incisional hernia can occur in the aponeurosis. This technique is more effective than the commonly used process, which involves large edges of mass closure. In this study investigators aim to compare small bites sutures in closure of laparotomy incision and standardized large bites sutures, and its affect in reducing the incidence of incisional hernia postoperative along with the surgical site infection. the investigators hypothesize that the small bites technique will result in a significant reduction of the incidence of incisional hernia and optimize the surgical site infection in major surgeries which may lead to a reduced morbidity and a better quality of life for patients and a significant reduction of costs.
    Detailed Description
    Incisional hernia carries with life-threatening conditions such as the incarceration of bowel strangulation. However, incisional hernia remains the most common complication after median laparotomy, with reported incidences varying between 2-20%. Even higher incidences up to 30-35% have been reported in obese and aortic aneurysm patients. Incisional hernia also causes life impairment and discomfort. Median laparotomy and the incisional hernia have been under investigation for quite some time, and information about patients' risk factors and suture materials has been identified. However, the risk factors associated with suture techniques are not yet thoroughly investigated. Many clinical tests and analyses have concluded that a mass closure technique involving a simple running suture is the most effective way to prevent incisional hernia and close a midline incision. The method is also easy and fast to perform compared to other layered methods involving interrupted sutures. Use of natural materials that are thin resorbable materials decreases the occurrence of the incisional hernial and lower the intensity of preoperative pain and wound infections compared to the use of suture materials that are non-resorbable. In this study the investigators aim to compare the small bites technique with a standardised large bites technique: Primary outcome: Incidence of Incisional Hernia postoperative. Pain scale. Secondary outcome: Quality of life, recovery, return to usual activity. Surgical site infection Time for closure. Study Design: Randomized Control Trial, Double blinded. Study area\ sitting : - The study will be conducted in King Fahad University Hospital, Khobar, Eastern Province, Saudi Arabia. Sample size: 108 patients Number of Arms (allocation): 2 Arms Arm1) Closure of laparotomy by small bites technique using PDS 2.0. Arm 2) Standardised large bites technique. Randomisation technique: Random.org Blinding technique: Double blinded. (patients and research recruiter) Follow up period: 6 months then 1 year, follow up by US. Outcome expected to measure: Study Subjects : Inclusion criteria: Laparotomy through a midline incision Age more than 18 BMI < 40 Exclusion criteria: Previous incisional hernia or fascial dehiscence with secondary healing after a midline incision. Abdominal surgery through a midline incision within the last three months. Pregnancy. Patient on steroids and with genetic anomalies. Malignancy patients, next exposed to radiation therapy. Data Collection methods, instruments used, and measurements: This research will include all patients who will had laparotomy through a midline incision according to our inclusion criteria, they will be randomised using computer generated numbers by using (Random.org), to either closure by small bites technique using PDS 2.0 or standardised large bites technique. The surgery will be done by either a consultant or a specialist following standard steps. A data sheet of each patient regarding their demographic, operation data, and postoperative recovery (pain, early mobilizing, wound healing, surgical site infection, retain to usual activity), then all patients will be followed for 6 month and 1 year postoperative by US, the endpoint is discovering of incisional hernia or not for 1 year follow up. Data Management and analysis plan: SPSS will be used for data analysis. Summary statistic will be obtained as frequency, and percentage for qualitative data, and means, medians and standard deviations from continuous variables. Chi square test will be used to examine the significant difference of hernia rate between the two study group. T test will be used to examine the difference in the mean of pain post-operative between the two study group. Ethical Considerations: Our study does not have any physical, psychological, social, legal, economic risk. The study will be reviewed by IRB, ethics committee; then the approval will be obtained. Written approval will be obtained from the patients prior to the procedure.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Incision, Surgical, Suture, Complication, Incisional Hernia

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    2 Arms Arm1) Closure of laparotomy by small bites technique using PDS 2.0 Arm2) Closure of laparotomy by standardised large bites technique This research will include all patients who will had laparotomy through a midline incision according to our inclusion criteria, they will be randomised using computer generated numbers by using (Random.org), to either closure by small bites technique using PDS 2.0 or standardised large bites technique.
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    Double blinded. (patients and research recruiter)
    Allocation
    Randomized
    Enrollment
    108 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Small Bite Technique Group
    Arm Type
    Active Comparator
    Arm Description
    closure of laparotomy by small bites technique using PDS 2.0
    Arm Title
    Standardised Large Bites Technique Group
    Arm Type
    Other
    Arm Description
    usual practice closure of laparotomy by standardised large bites technique using PDS 2.0
    Intervention Type
    Procedure
    Intervention Name(s)
    Small bite suturing Technique
    Intervention Description
    Small bite suturing technique with PDS 2.0
    Intervention Type
    Procedure
    Intervention Name(s)
    Standardised Large Bites Technique
    Intervention Description
    Standardised large bite suturing technique with PDS 2.0
    Primary Outcome Measure Information:
    Title
    Incidence of Incisional Hernia postoperative
    Description
    Incidence of Incisional Hernia postoperative, will be assessed by using Ultra Sound.
    Time Frame
    Follow up on 6 month postoperative.
    Title
    Incidence of Incisional Hernia postoperative
    Description
    Incidence of Incisional Hernia postoperative, will be assessed by using Ultra Sound.
    Time Frame
    Follow up on 1 year postoperative.
    Title
    Assessment of pain severity postoperative by pain scale
    Description
    Assessment of pain scale post operative, lower score mean a better outcome.
    Time Frame
    Day 1 postoperative
    Title
    Assessment of pain severity postoperative by pain scale
    Description
    Assessment of pain scale post operative, lower score mean a better outcome.
    Time Frame
    Day 2 postoperative
    Title
    Assessment of pain severity postoperative by pain scale
    Description
    Assessment of pain scale post operative, lower score mean a better outcome.
    Time Frame
    Day 3 postoperative
    Title
    Assessment of pain severity postoperative by pain scale
    Description
    Assessment of pain scale post operative, lower score mean a better outcome.
    Time Frame
    Day 4 postoperative
    Title
    Assessment of pain severity postoperative by pain scale
    Description
    Assessment of pain scale post operative, lower score mean a better outcome.
    Time Frame
    Day 5 postoperative
    Title
    Assessment of pain severity postoperative by pain scale
    Description
    Assessment of pain scale post operative, lower score mean a better outcome.
    Time Frame
    Day 6 postoperative
    Title
    Assessment of pain severity postoperative by pain scale
    Description
    Assessment of pain scale post operative, lower score mean a better outcome.
    Time Frame
    Day 7 postoperative
    Title
    Assessment of pain severity postoperative by pain scale
    Description
    Assessment of pain scale post operative, lower score mean a better outcome.
    Time Frame
    Day 8 postoperative
    Title
    Assessment of pain severity postoperative by pain scale
    Description
    Assessment of pain scale post operative, lower score mean a better outcome.
    Time Frame
    Day 9 postoperative
    Title
    Assessment of pain severity postoperative by pain scale
    Description
    Assessment of pain scale post operative, lower score mean a better outcome.
    Time Frame
    Day 10 postoperative
    Title
    Assessment of pain severity postoperative by pain scale
    Description
    Assessment of pain scale post operative, lower score mean a better outcome.
    Time Frame
    Day 11 postoperative
    Title
    Assessment of pain severity postoperative by pain scale
    Description
    Assessment of pain scale post operative, lower score mean a better outcome.
    Time Frame
    Day 12 postoperative
    Title
    Assessment of pain severity postoperative by pain scale
    Description
    Assessment of pain scale post operative, lower score mean a better outcome.
    Time Frame
    Day 13 postoperative
    Title
    Assessment of pain severity postoperative by pain scale
    Description
    Assessment of pain scale post operative, lower score mean a better outcome.
    Time Frame
    Day 14 postoperative
    Secondary Outcome Measure Information:
    Title
    Assessment of early mobilisation
    Description
    When the patient started to mobilise? assessed by monitoring the patients postoperative and record when he started to mobilise.
    Time Frame
    Postoperative period, assessment in day1.
    Title
    Assessment of early mobilisation
    Description
    When the patient started to mobilise? assessed by monitoring the patients postoperative and record when he started to mobilise.
    Time Frame
    Postoperative period, assessment in day2.
    Title
    Assessment of early mobilisation
    Description
    When the patient started to mobilise? assessed by monitoring the patients postoperative and record when he started to mobilise.
    Time Frame
    Postoperative period, assessment in day3.
    Title
    Retain to work (how many days between surgery and patient back to his work)
    Description
    When the patient back to his work or usual activity? assessed by monitoring the patients postoperative and record when he started to work again.
    Time Frame
    up to 6 weeks, postoperative period from discharge until day patient back to work.
    Title
    Surgical site infection of the wound postoperative
    Description
    Surgical site infection of the wound postoperative, if there is any sign of surgical site infection, itching, discharge, redness, fever, collection.
    Time Frame
    day 1 postoprtaive.
    Title
    Surgical site infection of the wound postoperative
    Description
    Surgical site infection of the wound postoperative, if there is any sign of surgical site infection, itching, discharge, redness, fever, collection.
    Time Frame
    day 2 postoprtaive.
    Title
    Surgical site infection of the wound postoperative
    Description
    Surgical site infection of the wound postoperative, if there is any sign of surgical site infection, itching, discharge, redness, fever, collection.
    Time Frame
    day 3 postoprtaive.
    Title
    Surgical site infection of the wound postoperative
    Description
    Surgical site infection of the wound postoperative, if there is any sign of surgical site infection, itching, discharge, redness, fever, collection.
    Time Frame
    day 4 postoprtaive.
    Title
    Surgical site infection of the wound postoperative
    Description
    Surgical site infection of the wound postoperative, if there is any sign of surgical site infection, itching, discharge, redness, fever, collection.
    Time Frame
    day 5 postoprtaive.
    Title
    Surgical site infection of the wound postoperative
    Description
    Surgical site infection of the wound postoperative, if there is any sign of surgical site infection, itching, discharge, redness, fever, collection.
    Time Frame
    day 6 postoprtaive.
    Title
    Surgical site infection of the wound postoperative
    Description
    Surgical site infection of the wound postoperative, if there is any sign of surgical site infection, itching, discharge, redness, fever, collection.
    Time Frame
    day 7 postoprtaive.
    Title
    Surgical site infection of the wound postoperative
    Description
    Surgical site infection of the wound postoperative, if there is any sign of surgical site infection, itching, discharge, redness, fever, collection.
    Time Frame
    day 8 postoprtaive.
    Title
    Surgical site infection of the wound postoperative
    Description
    Surgical site infection of the wound postoperative, if there is any sign of surgical site infection, itching, discharge, redness, fever, collection.
    Time Frame
    day 9 postoprtaive.
    Title
    Surgical site infection of the wound postoperative
    Description
    Surgical site infection of the wound postoperative, if there is any sign of surgical site infection, itching, discharge, redness, fever, collection.
    Time Frame
    day 10 postoprtaive.
    Title
    Surgical site infection of the wound postoperative
    Description
    Surgical site infection of the wound postoperative, if there is any sign of surgical site infection, itching, discharge, redness, fever, collection.
    Time Frame
    day 11 postoprtaive.
    Title
    Surgical site infection of the wound postoperative
    Description
    Surgical site infection of the wound postoperative, if there is any sign of surgical site infection, itching, discharge, redness, fever, collection.
    Time Frame
    day 12 postoprtaive.
    Title
    Surgical site infection of the wound postoperative
    Description
    Surgical site infection of the wound postoperative, if there is any sign of surgical site infection, itching, discharge, redness, fever, collection.
    Time Frame
    day 13 postoprtaive.
    Title
    Surgical site infection of the wound postoperative
    Description
    Surgical site infection of the wound postoperative, if there is any sign of surgical site infection, itching, discharge, redness, fever, collection.
    Time Frame
    day 14 postoprtaive.
    Title
    Time taken in closure of laparotomy incision (in minutes)
    Description
    Time taken for closure of the laparotomy incision, there will be timer, started from the beginning of suturing the laparotomy incision till the end. (in minutes)
    Time Frame
    intraoperative (through the closure of the laparotomy incision inside the operation room, suturing time (start to end) in minutes . (how many minutes surgeon took in suturing the incision))

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Laparotomy through a midline incision Age more than 18 BMI < 40 Exclusion Criteria: Previous incisional hernia or fascial dehiscence with secondary healing after a midline incision. Abdominal surgery through a midline incision within the last three months. Pregnancy. Patient on steroids and with genetic anomalies. Malignancy patients, next exposed to radiation therapy.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nasser M Amer
    Phone
    00966 53 865 9290
    Email
    nmamer@iau.edu.sa
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nasser M Amer
    Organizational Affiliation
    Imam Abdulrahman Bin Faisal University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Small Bite Technique Versus Standardised Large Bites Technique in Closure of Midline Laparotomies.

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