Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04788875
Status:
UNKNOWN
Last Update Posted:
2021-11-08
First Post:
2021-02-09
Brief Title:
Small Bite Technique Versus Standardised Large Bites Technique in Closure of Midline Laparotomies
Sponsor:
Imam Abdulrahman Bin Faisal University
Organization:
Imam Abdulrahman Bin Faisal University
Study Overview
Official Title:
Small Bite Technique Versus Standardised Large Bites Technique in Closure of Midline Laparotomies Randomised Control Trial
Status:
UNKNOWN
Status Verified Date:
2021-10
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SBT-CML
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
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
1 Incidence of Incisional Hernia postoperative
2 Pain scale
Secondary outcome
1 Quality of life recovery return to usual activity
2 Surgical site infection
3 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 20 Arm 2 Standardised large bites technique
Randomisation technique
Randomorg
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
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
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 Randomorg to either closure by small bites technique using PDS 20 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
In this study the investigators aim to compare the small bites technique with a standardised large bites technique
Primary outcome
1 Incidence of Incisional Hernia postoperative
2 Pain scale
Secondary outcome
1 Quality of life recovery return to usual activity
2 Surgical site infection
3 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 20 Arm 2 Standardised large bites technique
Randomisation technique
Randomorg
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
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
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 Randomorg to either closure by small bites technique using PDS 20 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None