<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03828409</url>
  </required_header>
  <id_info>
    <org_study_id>NMRR-16-1892-32723</org_study_id>
    <nct_id>NCT03828409</nct_id>
  </id_info>
  <brief_title>Comparison of Post-operative Pain in Short Versus Long Stitch for Laparotomy Closure</brief_title>
  <acronym>Shortstitch</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Malaya</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Malaya</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Laparotomy is a surgical procedure where an incision is made through the abdominal wall in&#xD;
      order to gain access to the peritoneal cavity. Midline laparotomy incisions were the main&#xD;
      type of abdominal access. However, there were complications associated with laparotomy such&#xD;
      as incisional hernia, post-operative pain, surgical site infection and burst abdomen. The&#xD;
      anterior abdominal wall consists of skin, fascia, subcutaneous fat, external oblique&#xD;
      aponeurosis, internal oblique muscles, transversus abdominis and rectus muscles. The skin and&#xD;
      parietal peritoneum are supplied by T7- T12 and L1 nerve. Hence, breaching of the peritoneum,&#xD;
      giving rise to post-operative laparotomy pain. It is reported that approximately 60% of&#xD;
      patients who underwent laparotomy do complain of post-operative pain.&#xD;
&#xD;
      Techniques of abdominal wall closure has been constantly in order to develop an ideal suture&#xD;
      technique to minimise wound complications. One of the most significant changes in abdominal&#xD;
      closure technique was the introduction of mass closure technique, known as 'long stitch'&#xD;
      (LS). This conventional mass closure, uses a suture-to-wound length ratio (SL:WL) of 4:1,&#xD;
      achieved by the use of continuous sutures at one centimetre from rectus edge with&#xD;
      inter-suture distance of one centimetre. Studies have shown LS caused compression of tissues&#xD;
      enclosed in the mass stitch, leading to tissue ischaemia and necrosis. 'Short stitch' (SS)&#xD;
      was introduced in 1980s where it was reported to result in lower rate of incisional hernia&#xD;
      and surgical site infection. It has a SL:WL of more than four, achieved by placing the suture&#xD;
      five millimetres from rectus edge with inter-suture distance of five millimetre as well. It&#xD;
      incorporates only the linea alba, which may reduce tension and post-operative pain.Studies&#xD;
      has indicate that approximately 40% of post-operative patients reported inadequate pain&#xD;
      relief despite therapeutic intervention. Inadequate pain control is associated with&#xD;
      complications such as atelectasis, prolonged immobilization and hospital stay, thromboembolic&#xD;
      event, cardiac morbidity, insomnia, ileus and poor wound healing The Visual Analog Scale&#xD;
      (VAS) of pain is commonly used as measures of pain score or intensity in clinical trials. A&#xD;
      more objective way to evaluate the post-operative pain is to assess the usage of&#xD;
      patient-controlled analgesia (PCA) over a period of time. The commonly used PCA drug for&#xD;
      post-operative patient is morphine. As SS relies on less tension and proper distribution of&#xD;
      force along the fascial plane, it is possible that it might reduce post-operative pain as&#xD;
      compared to LS technique. It can be assessed using total usage of analgesia (intravenous&#xD;
      infusion or PCA), with correlation to the respective visual-analogue scales (VAS) or numeric&#xD;
      rating scales (NRS) at that particular time. There is no study that evaluate post-operative&#xD;
      pain difference between SS and LS technique.&#xD;
&#xD;
      The hypothesis of this study is that SS will reduce PCA morphine usage after midline&#xD;
      laparotomy, which translate into reduction in post-operative pain. In order to detect the 30%&#xD;
      reduction of PCA morphine, 86 patients are required.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Laparotomy is a surgical procedure where an incision is made through the abdominal wall in&#xD;
      order to gain access to the peritoneal cavity. Midline laparotomy incisions were the main&#xD;
      type of abdominal access However, there were complications associated with laparotomy such as&#xD;
      incisional hernia, post-operative pain, surgical site infection and burst abdomen. The&#xD;
      anterior abdominal wall consists of skin, fascia, subcutaneous fat, external oblique&#xD;
      aponeurosis, internal oblique muscles, transversus abdominis and rectus muscles. The rectus&#xD;
      abdominis muscles is covered by rectus sheath, formed by aponeurosis of the internal oblique&#xD;
      muscles except posterior layer from the arcuate line downwards. The sheath contains the ends&#xD;
      of the lower six thoracic nerves (T7-T12) with first lumbar nerve The skin and parietal&#xD;
      peritoneum are supplied by T7- T12 and L1 nerve. Hence, breaching of the peritoneum, giving&#xD;
      rise to post-operative laparotomy pain. It is reported that approximately 60% of patients who&#xD;
      underwent laparotomy do complain of post-operative pain.&#xD;
&#xD;
      Techniques of abdominal wall closure has been constantly revised in order to develop an ideal&#xD;
      suture technique to minimise wound complications. One of the most significant changes in&#xD;
      abdominal closure technique was the introduction of mass closure technique, known as 'long&#xD;
      stitch' (LS). This conventional mass closure, uses a suture-to-wound length ratio (SL:WL) of&#xD;
      4:1, achieved by the use of continuous sutures at one centimetre from rectus edge with&#xD;
      inter-suture distance of one centimetre. Studies have shown LS caused compression of tissues&#xD;
      enclosed in the mass stitch, leading to tissue ischaemia and necrosis. 'Short stitch' (SS)&#xD;
      was introduced in 1980s where it was reported to result in lower rate of incisional hernia&#xD;
      and surgical site infection. It has a SL:WL of more than four, achieved by placing the suture&#xD;
      five millimetres from rectus edge with inter-suture distance of five millimetre as well. It&#xD;
      incorporates only the linea alba, which may reduce tension and post-operative pain.&#xD;
&#xD;
      Effective post-operative pain management is an important aspect in surgical patient care.&#xD;
      Studies has indicate that approximately 40% of post-operative patients reported inadequate&#xD;
      pain relief despite therapeutic intervention. Inadequate pain control is associated with&#xD;
      complications such as atelectasis, prolonged immobilization and hospital stay, thromboembolic&#xD;
      event, cardiac morbidity, insomnia, ileus and poor wound healing. The Visual Analog Scale&#xD;
      (VAS) of pain is commonly used as measures of pain score or intensity in clinical trials. A&#xD;
      more objective way to evaluate the post-operative pain is to assess the usage of&#xD;
      patient-controlled analgesia (PCA) over a period of time. The commonly used PCA drug for&#xD;
      post-operative patient is morphine. As SS relies on less tension and proper distribution of&#xD;
      force along the fascial plane, it is possible that it might reduce post-operative pain as&#xD;
      compared to LS technique. It can be assessed using total usage of analgesia (intravenous&#xD;
      infusion or PCA), with correlation to the respective visual-analogue scales (VAS) or numeric&#xD;
      rating scales (NRS) at that particular time. There is no study that evaluate post-operative&#xD;
      pain difference between SS and LS technique.&#xD;
&#xD;
      This is a prospective, multi-centered, double-blind randomized controlled trial to look into&#xD;
      comparison of post-operative pain after elective laparotomy: short versus long stitch&#xD;
      technique of closure in two tertiary hospitals. The study started in January 2017 and&#xD;
      completed in November 2018. Patient who fulfilled the criteria of recruitment were included&#xD;
      into this study.&#xD;
&#xD;
      In order to detect difference of 30% of PCA morphine usage, 86 patients are required. Both&#xD;
      group of patients will received equal pre-operative analgesia, antibiotics and induction&#xD;
      again. Patients will be randomized into LS and SS group. Once the aim of the surgery is&#xD;
      achieved, the operating surgeon will open the sealed enveloped, which contain the group and&#xD;
      technique of suture used. Postoperatively patient will be receiving oral paracetamol and&#xD;
      taught on PCA morphine usage. PCA morphine usage and VAS score will be assessed by medical&#xD;
      officer that are blinded to the treatment. Primary outcome is PCA morphine usage 24 hours&#xD;
      post-surgery. Secondary outcome are presence of surgical site infection and length of&#xD;
      hospital stay. Patients will subsequently be discharged by the surgeon in charge based on the&#xD;
      discharge criteria. Patients will be follow-up in outpatient clinic on same interval.&#xD;
      Presence of adverse events or complications will be documented.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">November 2018</completion_date>
  <primary_completion_date type="Actual">November 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_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.&#xD;
This study is carried out to evaluate if SS technique will reduce post-operative pain.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <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.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Reduction of PCA morphine usage post-operatively</measure>
    <time_frame>24 hours</time_frame>
    <description>Measure total usage of PCA morphine</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Presence of Surgical site infection</measure>
    <time_frame>throughout hospital stay, 2 weeks, 6 weeks and then 8 weeks during follow up (up to 1 year)</time_frame>
    <description>Any surgical site infection at surgical site</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>since day 1 hospital admission until the time when patient is deemed fit to be discharged (up to 1 month)</time_frame>
    <description>number of days patient was admitted in the ward</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">86</enrollment>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>Short stitch</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>short stitch used as one arm</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Long stitch</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Long stitch as conventional mass-closure technique</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Short stitch</intervention_name>
    <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.</description>
    <arm_group_label>Long stitch</arm_group_label>
    <arm_group_label>Short stitch</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Long stitch</intervention_name>
    <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</description>
    <arm_group_label>Long stitch</arm_group_label>
    <arm_group_label>Short stitch</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Elective primary midline laparotomy,&#xD;
&#xD;
          -  ASA Class I to III&#xD;
&#xD;
          -  hemodynamically stable&#xD;
&#xD;
          -  able to provide consent for surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Emergency laparotomy&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  history of previous midline laparotomy&#xD;
&#xD;
          -  allergic to opiates&#xD;
&#xD;
          -  unable to use PCA morphine (handicapped)&#xD;
&#xD;
          -  patient will be planned for stoma creation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>January 30, 2019</last_update_submitted>
  <last_update_submitted_qc>January 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>short stitch</keyword>
  <keyword>post-operative pain</keyword>
  <keyword>PCA morphine usage</keyword>
  <keyword>elective midline laparotomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03828409
org study id: NMRR-16-1892-32723
nct id: NCT03828409
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention 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.
primary purpose: Prevention
masking: Double (Participant, Outcomes 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.
measure: Reduction of PCA morphine usage post-operatively
time frame: 24 hours
description: Measure total usage of PCA morphine
measure: Presence of Surgical site infection
time frame: throughout hospital stay, 2 weeks, 6 weeks and then 8 weeks during follow up (up to 1 year)
description: Any surgical site infection at surgical site
measure: Length of hospital stay
time frame: since day 1 hospital admission until the time when patient is deemed fit to be discharged (up to 1 month)
description: number of days patient was admitted in the ward
arm group label: Short stitch
arm group type: Active Comparator
description: short stitch used as one arm
arm group label: Long stitch
arm group type: Active Comparator
description: Long stitch as conventional mass-closure technique
intervention type: Procedure
intervention name: Short stitch
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.
arm group label: Long stitch
arm group label: Short stitch
intervention type: Procedure
intervention name: Long stitch
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
arm group label: Long stitch
arm group label: Short stitch
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Pain, Postoperative