Suture Size, Incisional HerniaNCT05474677
The Suture Size in Laparotomy Wound Closure to Prevent Post-operative Complications
A study testing closure of the abdominal fascia in people with Suture Size, Incisional Hernia, run by Raya Al shaaibi at 1 site in Oman.
Trial summary
Background: Incisional hernia is a common complication of midline laparotomy, and it is associated with high morbidity and high costs. Suture size used in the closure of the abdominal wall fascia was not studied independently. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Suture Size, Incisional Hernia
- What is being tested?
- closure of the abdominal fascia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 1 siteOman
- Study dates
- 1 Aug 2022to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adults aged 18 years or older, who signed informed consent and the expected survival more than one year.
Who cannot join
- Patients with history of midline laparotomy within 3 months, pregnant patients and patients with history of incisional hernia
Trial locations and contacts
1 site in 1 country.
About this study
Background: Incisional hernia is a common complication of midline laparotomy, and it is associated with high morbidity and high costs. Suture size used in the closure of the abdominal wall fascia was not studied independently.
Objective: Identify the best suture size for closure of the fascia following laparotomy incisions, by assessing the suture size 2\0 versus zero.
Research methods: Prospective, multicentric, randomized controlled and double-blind trial. Patients undergoing elective or emergency laparotomy in Royal Hospital, Sultan Qaboos University Hospital and Armed Force Hospital between 2022 and 2023. We aimed for a total of 276 patients (n=138 per group). The abdomen will be closed in intervention group with continuous PDS 2\0 sutures and size zero in control group. Patients will be followed for immediate post-operative wound complications and late complication after 6 months then after one year.
Read the detailed description
Objectives and hypothesis of the study The primary objective: to identify the best suture size for closure of the fascia following laparotomy incisions to prevent incisional hernia, by assessing the suture size 2\0 versus zero.
Secondary objective: assess the incidence of wound dehiscence and wound infection in two studied group.
Study hypothesis: Suture size 2/0 decreases the incidence of incisional hernia in the closure of the abdominal fascia
Research design and Methods Study design: Prospective, multicentric, randomized controlled and double-blind trial.
Characteristics of study area and target population Patients undergoing elective or emergency laparotomy in Royal Hospital, Sultan Qaboos University Hospital and Armed Force Hospital between 2022 and 2023. Eligible patients are adults aged 18 years or older, who signed informed consent and the expected survival more than one year. Patients with history of midline laparotomy within 3 months, pregnant patients and patients with history of incisional hernia will be excluded from the study.
Sampling we estimated that 125 patients would be needed in each group to provide 80% power to detect a reduction of at least 50% (18% in the classic group vs 6% in the 2.0 group) in the incidence of incisional hernia at a two-sided alpha level 0.05. We aimed for a total of 276 patients (n=138 per group) to correct for an estimated 10% loss to follow-up in each group. The statistical method used was Fisher's exact test. The calculation was done using the software G*Power version 3.1.9.2. Randomization will be achieved by using a software.
Variable definitions and measurements The abdomen will be closed in the intervention group patients with continuous PDS 2\0 sutures, half centimeter between each stitch. The control group will be closed by the conventional method in the Royal Hospital, continuous using double-looped. Sex, age, BMI, smoking, diabetes mellitus, COPD, cardiovascular disease, corticosteroid use, previous laparotomy, ASA classification, preoperative chemotherapy, preoperative radiotherapy, type of surgery are the variable which will be studied.
Data collection tools and methods Data will be entered using Epi-data software.
Data quality State how data will be entered using Epi-data software.
Data analysis Continuous variables will be presented as mean, median, and standard deviation whereas, categorical variables will be presented as frequency and percentage. Comparison of means between two groups will be assessed using the independent samples t-test or the Mann-Whitney U test, as appropriate. Association between two categorical variables will be assessed using an appropriate Chi-square test (Likelihood ratio test or Fisher's exact test). Multivariate log-binomial regression analysis will be used to determine the independent risk factors for the development of incisional hernia. A P-value less than 0.05 will be considered statistically significant. All the analysis will be done using the IBM SPSS statistics version 26.0.
- Conditions
- Suture Size, Incisional Hernia
- Being tested
- closure of the abdominal fascia
- Medical subject headings
- Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
closure of the abdominal fasciaProcedure or surgery
The abdomen will be closed in intervention group with continuous PDS 2\0 sutures and size zero in control group.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | intervention group with the abdomen will be closed with continuous PDS 2\0 sutures Receives: Procedure: closure of the abdominal fascia |
| control group | Experimental | the abdomen will be closed with continuous sutures size zero Receives: Procedure: closure of the abdominal fascia |
What is being measured
The primary outcome is the main question the study is designed to answer.
incisional hernia
development of incisional hernia post operative
Measured: 6 months and one year
Secondary outcomes (2)
wound infection
development of wound infection post operative
Measured: 30 days
wound dehiscence
development of wound dehiscence post operative
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start1 Aug 2022 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suture Size, Incisional HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 276 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Raya Al shaaibi
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Raya Al shaaibi, Oman Medical Speciality Board
- Investigators
- mohmmed al abri, consultant, Study director, Oman Medical Specialty Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05474677
- Sponsor's protocol ID
- OmanMedSB
- Status last verified
- Aug 2022
- First submitted
- 23 Jul 2022
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: participant data will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Suture Size in Laparotomy Wound Closure to Prevent Post-operative Complications
- ClinicalTrials.gov ID
- NCT05474677
- Acronym / sponsor ID
- OmanMedSB
- Conditions
- Suture Size, Incisional Hernia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 276 participants (estimated)
- Lead sponsor
- Raya Al shaaibiOther government
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 26 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Incisional hernia is a common complication of midline laparotomy, and it is associated with high morbidity and high costs. Suture size used in the closure of the abdominal wall fascia was not studied independently.
Objective: Identify the best suture size for closure of the fascia following laparotomy incisions, by assessing the suture size 2\0 versus zero.
Research methods: Prospective, multicentric, randomized controlled and double-blind trial. Patients undergoing elective or emergency laparotomy in Royal Hospital, Sultan Qaboos University Hospital and Armed Force Hospital between 2022 and 2023. We aimed for a total of 276 patients (n=138 per group). The abdomen will be closed in intervention group with continuous PDS 2\0 sutures and size zero in control group. Patients will be followed for immediate post-operative wound complications and late complication after 6 months then after one year.
Detailed description
Objectives and hypothesis of the study The primary objective: to identify the best suture size for closure of the fascia following laparotomy incisions to prevent incisional hernia, by assessing the suture size 2\0 versus zero.
Secondary objective: assess the incidence of wound dehiscence and wound infection in two studied group.
Study hypothesis: Suture size 2/0 decreases the incidence of incisional hernia in the closure of the abdominal fascia
Research design and Methods Study design: Prospective, multicentric, randomized controlled and double-blind trial.
Characteristics of study area and target population Patients undergoing elective or emergency laparotomy in Royal Hospital, Sultan Qaboos University Hospital and Armed Force Hospital between 2022 and 2023. Eligible patients are adults aged 18 years or older, who signed informed consent and the expected survival more than one year. Patients with history of midline laparotomy within 3 months, pregnant patients and patients with history of incisional hernia will be excluded from the study.
Sampling we estimated that 125 patients would be needed in each group to provide 80% power to detect a reduction of at least 50% (18% in the classic group vs 6% in the 2.0 group) in the incidence of incisional hernia at a two-sided alpha level 0.05. We aimed for a total of 276 patients (n=138 per group) to correct for an estimated 10% loss to follow-up in each group. The statistical method used was Fisher's exact test. The calculation was done using the software G*Power version 3.1.9.2. Randomization will be achieved by using a software.
Variable definitions and measurements The abdomen will be closed in the intervention group patients with continuous PDS 2\0 sutures, half centimeter between each stitch. The control group will be closed by the conventional method in the Royal Hospital, continuous using double-looped. Sex, age, BMI, smoking, diabetes mellitus, COPD, cardiovascular disease, corticosteroid use, previous laparotomy, ASA classification, preoperative chemotherapy, preoperative radiotherapy, type of surgery are the variable which will be studied.
Data collection tools and methods Data will be entered using Epi-data software.
Data quality State how data will be entered using Epi-data software.
Data analysis Continuous variables will be presented as mean, median, and standard deviation whereas, categorical variables will be presented as frequency and percentage. Comparison of means between two groups will be assessed using the independent samples t-test or the Mann-Whitney U test, as appropriate. Association between two categorical variables will be assessed using an appropriate Chi-square test (Likelihood ratio test or Fisher's exact test). Multivariate log-binomial regression analysis will be used to determine the independent risk factors for the development of incisional hernia. A P-value less than 0.05 will be considered statistically significant. All the analysis will be done using the IBM SPSS statistics version 26.0.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Procedure: closure of the abdominal fasciaintervention group with the abdomen will be closed with continuous PDS 2\0 sutures |
| control group | Experimental | Procedure: closure of the abdominal fasciathe abdomen will be closed with continuous sutures size zero |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adults aged 18 years or older, who signed informed consent and the expected survival more than one year.
Key exclusion criteria (1 listed)
- Patients with history of midline laparotomy within 3 months, pregnant patients and patients with history of incisional hernia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| closure of the abdominal fasciaThe abdomen will be closed in intervention group with continuous PDS 2\0 sutures and size zero in control group. | Procedure or surgery | control group, intervention group |
Primary outcome
incisional hernia
Time frame: 6 months and one year
development of incisional hernia post operative
2 secondary outcomes
wound infection
Time frame: 30 days
wound dehiscence
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Individual participant dataSharing planned: No. participant data will not be shared
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
mohmmed al abri, consultant study director
Oman Medical Specialty Board
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing closure of the abdominal fascia in people with Suture Size, Incisional Hernia, run by Raya Al shaaibi at 1 site in Oman.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Oman. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incisional hernia (time frame: 6 months and one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2022.