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

NCT ID: NCT04788875

Last Updated: 2021-11-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2023-11-30

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:

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 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:

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 (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.

Conditions

Incision, Surgical; Suture, Complication; Incisional Hernia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Small Bite Technique Group

closure of laparotomy by small bites technique using PDS 2.0

Group Type: ACTIVE_COMPARATOR

Small bite suturing Technique

Intervention Type: PROCEDURE

Small bite suturing technique with PDS 2.0

Standardised Large Bites Technique Group

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

Group Type: OTHER

Standardised Large Bites Technique

Intervention Type: PROCEDURE

Standardised large bite suturing technique with PDS 2.0

Interventions

Small bite suturing Technique

Small bite suturing technique with PDS 2.0

Intervention Type: PROCEDURE

Standardised Large Bites Technique

Standardised large bite suturing technique with PDS 2.0

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Imam Abdulrahman Bin Faisal University

OTHER

Sponsor Role: lead

Responsible Party

Nasser Mohamed Amer

Assistant professor of General Surgery in Imam Abdulrahman bin Faisal University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nasser M Amer

Role: PRINCIPAL_INVESTIGATOR

Imam Abdulrahman Bin Faisal University

Central Contacts

Nasser M Amer

Role: CONTACT

Phone: 00966 53 865 9290

Email: nmamer@iau.edu.sa

Other Identifiers

SBT-CML

Identifier Type: -

Identifier Source: org_study_id