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
About this trial
This is an interventional prevention trial for Incision, Surgical
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.
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
NCT ID
NCT04788875
First Posted
February 9, 2021
Last Updated
October 31, 2021
Sponsor
Imam Abdulrahman Bin Faisal University
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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