CompletedNot Applicable

Comparison of Small-bite Versus Conventional Midline Fascial Closure in Abdominal Surgeries

Turkey (Türkiye)217 participantsStarted 2021-05-01

Plain-language summary

This study investigates how different incision and fascial closure (suture) techniques used in abdominal surgery are associated with the development of incisional hernia, a common long-term complication after laparotomy. Incisional hernia can cause pain, impaired quality of life, and may require additional surgery, making its prevention clinically important. Adult patients undergoing midline abdominal surgery were followed prospectively. During surgery, detailed information about the incision and closure technique was recorded, including the type of fascial closure (small-bite versus conventional technique), incision length, suture length, and the suture-to-wound length ratio. Patient-related factors such as age, body mass index, comorbidities, and preoperative laboratory values were also collected. After surgery, patients were monitored for early wound complications, such as surgical site infection or wound dehiscence, and were followed for up to 12 months to assess whether an incisional hernia developed. Hernia diagnosis was based on clinical examination and ultrasonographic evaluation. The main goal of the study is to identify which technical and patient-related factors are independently associated with the risk of incisional hernia. In particular, the study evaluates whether the small-bite fascial closure technique, which uses smaller and more closely spaced stitches, is associated with a lower risk of hernia formation and wound complications compared with conventional closure methods. Secondary objectives include assessing factors related to early postoperative wound complications and length of hospital stay. By integrating surgical technique details with patient characteristics and postoperative outcomes, this study aims to improve understanding of modifiable risk factors for incisional hernia. The results may help surgeons choose closure techniques more effectively and improve postoperative outcomes for patients undergoing abdominal surgery.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult patients (≥18 years of age) undergoing midline abdominal surgery * Patients undergoing elective or emergency laparotomy * Use of a midline abdominal incision with primary fascial closure * Application of either small-bite or conventional fascial closure technique * Availability of complete intraoperative data regarding incision and suture characteristics * Provision of written informed consent * Ability to participate in postoperative follow-up Exclusion Criteria: * Previous midline laparotomy or pre-existing incisional hernia * Relaparotomy for indications other than incisional hernia * Laparoscopic or minimally invasive procedures without midline fascial closure * Presence of a pre-existing abdominal wall defect at the incision site * Incomplete intraoperative data on closure technique or suture measurements * Loss to follow-up or inability to complete 12-month postoperative assessment

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial compared a 'small-bite' stitching technique to the standard way of closing the abdominal incision — can you explain what the difference is and whether the results showed one method was better at preventing hernia at the wound site?
2Since this trial has already been completed, have the results been published yet, and if so, what did they find about whether the small-bite closure reduced the risk of incisional hernia compared to the conventional approach?
3If I need abdominal surgery, is the small-bite closure technique something you already use or would consider using, based on what this trial and other research have shown?
4This trial also looked at surgical site infections as a concern — did the results suggest that one closure method had a lower risk of wound infection, and is that something we should factor into planning my surgery?
5Are there specific types of abdominal surgeries or patient situations — like my own health history — where one closure technique tends to work better than the other, based on what studies like this one have found?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incisional Hernia

Timeframe: 12 months

Trial details

NCT IDNCT07340918

SponsorMuğla Sıtkı Koçman University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-07-31

View on ClinicalTrials.gov More Incisional Hernia/Prevention and Control trials