The Suture Size in Laparotomy Wound Closure to Prevent Post-operative Complications
Primary Purpose
Suture Size, Incisional Hernia
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Oman
Study Type
Interventional
Intervention
closure of the abdominal fascia
Sponsored by
About this trial
This is an interventional treatment trial for Suture Size, Incisional Hernia
Eligibility Criteria
Inclusion Criteria:
- adults aged 18 years or older, who signed informed consent and the expected survival more than one year.
Exclusion Criteria:
- Patients with history of midline laparotomy within 3 months, pregnant patients and patients with history of incisional hernia
Sites / Locations
- Raya Al Shaaibi
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
intervention group
control group
Arm Description
intervention group with the abdomen will be closed with continuous PDS 2\0 sutures
the abdomen will be closed with continuous sutures size zero
Outcomes
Primary Outcome Measures
incisional hernia
development of incisional hernia post operative
Secondary Outcome Measures
wound infection
development of wound infection post operative
wound dehiscence
development of wound dehiscence post operative
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05474677
Brief Title
The Suture Size in Laparotomy Wound Closure to Prevent Post-operative Complications
Official Title
The Suture Size in Laparotomy Wound Closure to Prevent Post-operative Complications
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 1, 2022 (Anticipated)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Raya Al shaaibi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suture Size, Incisional Hernia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
276 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
intervention group
Arm Type
Experimental
Arm Description
intervention group with the abdomen will be closed with continuous PDS 2\0 sutures
Arm Title
control group
Arm Type
Experimental
Arm Description
the abdomen will be closed with continuous sutures size zero
Intervention Type
Procedure
Intervention Name(s)
closure of the abdominal fascia
Intervention Description
The abdomen will be closed in intervention group with continuous PDS 2\0 sutures and size zero in control group.
Primary Outcome Measure Information:
Title
incisional hernia
Description
development of incisional hernia post operative
Time Frame
6 months and one year
Secondary Outcome Measure Information:
Title
wound infection
Description
development of wound infection post operative
Time Frame
30 days
Title
wound dehiscence
Description
development of wound dehiscence post operative
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
adults aged 18 years or older, who signed informed consent and the expected survival more than one year.
Exclusion Criteria:
Patients with history of midline laparotomy within 3 months, pregnant patients and patients with history of incisional hernia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mohmmed al abri, consultant
Organizational Affiliation
Oman Medical Specialty Board
Official's Role
Study Director
Facility Information:
Facility Name
Raya Al Shaaibi
City
Muscat
ZIP/Postal Code
123
Country
Oman
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
participant data will not be shared
Learn more about this trial
The Suture Size in Laparotomy Wound Closure to Prevent Post-operative Complications
We'll reach out to this number within 24 hrs