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Comparison of Post-operative Pain in Short Versus Long Stitch for Laparotomy Closure (Shortstitch)

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Short stitch
Long stitch
Sponsored by
University of Malaya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain, Postoperative focused on measuring short stitch, post-operative pain, PCA morphine usage, elective midline laparotomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Elective primary midline laparotomy,
  • ASA Class I to III
  • hemodynamically stable
  • able to provide consent for surgery

Exclusion Criteria:

  • Emergency laparotomy
  • pregnancy
  • history of previous midline laparotomy
  • allergic to opiates
  • unable to use PCA morphine (handicapped)
  • patient will be planned for stoma creation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Short stitch

    Long stitch

    Arm Description

    short stitch used as one arm

    Long stitch as conventional mass-closure technique

    Outcomes

    Primary Outcome Measures

    Reduction of PCA morphine usage post-operatively
    Measure total usage of PCA morphine

    Secondary Outcome Measures

    Presence of Surgical site infection
    Any surgical site infection at surgical site
    Length of hospital stay
    number of days patient was admitted in the ward

    Full Information

    First Posted
    January 28, 2019
    Last Updated
    January 30, 2019
    Sponsor
    University of Malaya
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03828409
    Brief Title
    Comparison of Post-operative Pain in Short Versus Long Stitch for Laparotomy Closure
    Acronym
    Shortstitch
    Official Title
    Comparison Of Post-operative Pain In Short Versus Long Stitch Technique For Abdominal Wall Closure After Elective Laparotomy- A Double-Blind, Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2017 (Actual)
    Primary Completion Date
    November 2018 (Actual)
    Study Completion Date
    November 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Malaya

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Laparotomy is a surgical procedure where an incision is made through the abdominal wall in order to gain access to the peritoneal cavity. Midline laparotomy incisions were the main type of abdominal access. However, there were complications associated with laparotomy such as incisional hernia, post-operative pain, surgical site infection and burst abdomen. The anterior abdominal wall consists of skin, fascia, subcutaneous fat, external oblique aponeurosis, internal oblique muscles, transversus abdominis and rectus muscles. The skin and parietal peritoneum are supplied by T7- T12 and L1 nerve. Hence, breaching of the peritoneum, giving rise to post-operative laparotomy pain. It is reported that approximately 60% of patients who underwent laparotomy do complain of post-operative pain. Techniques of abdominal wall closure has been constantly in order to develop an ideal suture technique to minimise wound complications. One of the most significant changes in abdominal closure technique was the introduction of mass closure technique, known as 'long stitch' (LS). This conventional mass closure, uses a suture-to-wound length ratio (SL:WL) of 4:1, achieved by the use of continuous sutures at one centimetre from rectus edge with inter-suture distance of one centimetre. Studies have shown LS caused compression of tissues enclosed in the mass stitch, leading to tissue ischaemia and necrosis. 'Short stitch' (SS) was introduced in 1980s where it was reported to result in lower rate of incisional hernia and surgical site infection. It has a SL:WL of more than four, achieved by placing the suture five millimetres from rectus edge with inter-suture distance of five millimetre as well. It incorporates only the linea alba, which may reduce tension and post-operative pain.Studies has indicate that approximately 40% of post-operative patients reported inadequate pain relief despite therapeutic intervention. Inadequate pain control is associated with complications such as atelectasis, prolonged immobilization and hospital stay, thromboembolic event, cardiac morbidity, insomnia, ileus and poor wound healing The Visual Analog Scale (VAS) of pain is commonly used as measures of pain score or intensity in clinical trials. A more objective way to evaluate the post-operative pain is to assess the usage of patient-controlled analgesia (PCA) over a period of time. The commonly used PCA drug for post-operative patient is morphine. As SS relies on less tension and proper distribution of force along the fascial plane, it is possible that it might reduce post-operative pain as compared to LS technique. It can be assessed using total usage of analgesia (intravenous infusion or PCA), with correlation to the respective visual-analogue scales (VAS) or numeric rating scales (NRS) at that particular time. There is no study that evaluate post-operative pain difference between SS and LS technique. The hypothesis of this study is that SS will reduce PCA morphine usage after midline laparotomy, which translate into reduction in post-operative pain. In order to detect the 30% reduction of PCA morphine, 86 patients are required.
    Detailed Description
    Laparotomy is a surgical procedure where an incision is made through the abdominal wall in order to gain access to the peritoneal cavity. Midline laparotomy incisions were the main type of abdominal access However, there were complications associated with laparotomy such as incisional hernia, post-operative pain, surgical site infection and burst abdomen. The anterior abdominal wall consists of skin, fascia, subcutaneous fat, external oblique aponeurosis, internal oblique muscles, transversus abdominis and rectus muscles. The rectus abdominis muscles is covered by rectus sheath, formed by aponeurosis of the internal oblique muscles except posterior layer from the arcuate line downwards. The sheath contains the ends of the lower six thoracic nerves (T7-T12) with first lumbar nerve The skin and parietal peritoneum are supplied by T7- T12 and L1 nerve. Hence, breaching of the peritoneum, giving rise to post-operative laparotomy pain. It is reported that approximately 60% of patients who underwent laparotomy do complain of post-operative pain. Techniques of abdominal wall closure has been constantly revised in order to develop an ideal suture technique to minimise wound complications. One of the most significant changes in abdominal closure technique was the introduction of mass closure technique, known as 'long stitch' (LS). This conventional mass closure, uses a suture-to-wound length ratio (SL:WL) of 4:1, achieved by the use of continuous sutures at one centimetre from rectus edge with inter-suture distance of one centimetre. Studies have shown LS caused compression of tissues enclosed in the mass stitch, leading to tissue ischaemia and necrosis. 'Short stitch' (SS) was introduced in 1980s where it was reported to result in lower rate of incisional hernia and surgical site infection. It has a SL:WL of more than four, achieved by placing the suture five millimetres from rectus edge with inter-suture distance of five millimetre as well. It incorporates only the linea alba, which may reduce tension and post-operative pain. Effective post-operative pain management is an important aspect in surgical patient care. Studies has indicate that approximately 40% of post-operative patients reported inadequate pain relief despite therapeutic intervention. Inadequate pain control is associated with complications such as atelectasis, prolonged immobilization and hospital stay, thromboembolic event, cardiac morbidity, insomnia, ileus and poor wound healing. The Visual Analog Scale (VAS) of pain is commonly used as measures of pain score or intensity in clinical trials. A more objective way to evaluate the post-operative pain is to assess the usage of patient-controlled analgesia (PCA) over a period of time. The commonly used PCA drug for post-operative patient is morphine. As SS relies on less tension and proper distribution of force along the fascial plane, it is possible that it might reduce post-operative pain as compared to LS technique. It can be assessed using total usage of analgesia (intravenous infusion or PCA), with correlation to the respective visual-analogue scales (VAS) or numeric rating scales (NRS) at that particular time. There is no study that evaluate post-operative pain difference between SS and LS technique. This is a prospective, multi-centered, double-blind randomized controlled trial to look into comparison of post-operative pain after elective laparotomy: short versus long stitch technique of closure in two tertiary hospitals. The study started in January 2017 and completed in November 2018. Patient who fulfilled the criteria of recruitment were included into this study. In order to detect difference of 30% of PCA morphine usage, 86 patients are required. Both group of patients will received equal pre-operative analgesia, antibiotics and induction again. Patients will be randomized into LS and SS group. Once the aim of the surgery is achieved, the operating surgeon will open the sealed enveloped, which contain the group and technique of suture used. Postoperatively patient will be receiving oral paracetamol and taught on PCA morphine usage. PCA morphine usage and VAS score will be assessed by medical officer that are blinded to the treatment. Primary outcome is PCA morphine usage 24 hours post-surgery. Secondary outcome are presence of surgical site infection and length of hospital stay. Patients will subsequently be discharged by the surgeon in charge based on the discharge criteria. Patients will be follow-up in outpatient clinic on same interval. Presence of adverse events or complications will be documented.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Postoperative
    Keywords
    short stitch, post-operative pain, PCA morphine usage, elective midline laparotomy

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Patients will be randomized into two arms (short stitch: SS and long stitch:LS).The LS belongs to our conventional mass closure technique for midline laparotomy. SS technique has been used to investigate other parameters such as surgical site infection and incisional hernia. This study is carried out to evaluate if SS technique will reduce post-operative pain.
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    Patient will not know what technique was used for the abdominal wall closure. The medical officers that will assess patient's PCA morphine usage and VAS score post-operatively will not know which technique of suturing was used for that particular patient.
    Allocation
    Randomized
    Enrollment
    86 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Short stitch
    Arm Type
    Active Comparator
    Arm Description
    short stitch used as one arm
    Arm Title
    Long stitch
    Arm Type
    Active Comparator
    Arm Description
    Long stitch as conventional mass-closure technique
    Intervention Type
    Procedure
    Intervention Name(s)
    Short stitch
    Intervention Description
    The rectus sheath are cleaned off the subcutaneous fats. Short stitch technique uses smaller needle and suture material. The suture is placed nearer to each other as compared to our conventional long stitch technique. It has inter-suture distance of 5mm and 5mm distance from rectus edge. The suture will be started at one end and sutured continuous until the other end. Hence, this technique is applied without tension.
    Intervention Type
    Procedure
    Intervention Name(s)
    Long stitch
    Intervention Description
    Long stitch uses a larger needle and suture material. The suture is placed 1cm from the linea alba and 1 cm from previous suture. This technique include mass closure sutures at the midline laparotomy
    Primary Outcome Measure Information:
    Title
    Reduction of PCA morphine usage post-operatively
    Description
    Measure total usage of PCA morphine
    Time Frame
    24 hours
    Secondary Outcome Measure Information:
    Title
    Presence of Surgical site infection
    Description
    Any surgical site infection at surgical site
    Time Frame
    throughout hospital stay, 2 weeks, 6 weeks and then 8 weeks during follow up (up to 1 year)
    Title
    Length of hospital stay
    Description
    number of days patient was admitted in the ward
    Time Frame
    since day 1 hospital admission until the time when patient is deemed fit to be discharged (up to 1 month)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Elective primary midline laparotomy, ASA Class I to III hemodynamically stable able to provide consent for surgery Exclusion Criteria: Emergency laparotomy pregnancy history of previous midline laparotomy allergic to opiates unable to use PCA morphine (handicapped) patient will be planned for stoma creation

    12. IPD Sharing Statement

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    Comparison of Post-operative Pain in Short Versus Long Stitch for Laparotomy Closure

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