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

NCT ID: NCT07340918

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 217 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2024-07-31

Brief 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.

Detailed Description

This study is designed as a prospective observational cohort investigation evaluating the relationship between abdominal incision characteristics, fascial closure (suture) techniques, and the subsequent development of incisional hernia following midline laparotomy. Incisional hernia represents one of the most frequent long-term complications after abdominal surgery and is associated with significant morbidity, impaired physical function, and the need for reoperation. Despite advances in surgical techniques, the relative contribution of technical factors and patient-related characteristics remains incompletely defined, particularly in heterogeneous populations that include both elective and emergency procedures.

Consecutive adult patients undergoing midline abdominal surgery were enrolled and followed longitudinally. The study does not involve randomization or protocol-driven assignment of surgical techniques; instead, closure methods were selected according to routine clinical practice and surgeon preference. Two commonly used fascial closure techniques were evaluated: the small-bite technique, characterized by closely spaced, shallow bites of the fascia, and the conventional technique, which uses wider and more widely spaced stitches. Intraoperative technical parameters were recorded in real time, including incision length, total suture length used for fascial closure, suture-to-wound length ratio, suture material, needle characteristics, and closure duration.

In addition to technical variables, comprehensive patient-related data were collected, including demographic characteristics, body mass index, comorbidity burden, surgical urgency (elective or emergency), wound classification, and relevant preoperative laboratory values reflecting nutritional and inflammatory status. Postoperatively, patients were monitored for early wound-related complications, such as surgical site infection, wound dehiscence, and evisceration, which were analyzed both individually and as a composite outcome.

Long-term follow-up was conducted using a standardized protocol. All participants were evaluated at 12 months after surgery for the presence of incisional hernia. Hernia assessment was based on structured clinical examination and confirmatory ultrasonographic imaging performed by study investigators. This approach was chosen to improve diagnostic accuracy and to capture both clinically apparent and subclinical hernias.

The primary outcome of the study is the occurrence of incisional hernia within 12 months of the index operation. Secondary outcomes include the development of early postoperative wound complications and duration of hospital stay. The analytical strategy focuses on identifying independent predictors of incisional hernia by integrating patient-related, intraoperative, and postoperative variables within multivariable statistical models. Particular emphasis is placed on evaluating whether specific closure techniques and quantitative measures of suturing, such as the suture-to-wound length ratio, are associated with reduced hernia risk after adjustment for potential confounders.

By systematically documenting real-world surgical practice and linking technical details to both short-term and long-term outcomes, this study aims to clarify modifiable factors that may reduce the incidence of incisional hernia. The findings are intended to support evidence-based decision-making in abdominal wall closure and to inform future strategies for improving surgical quality and patient outcomes.

Conditions

Incisional Hernia/Prevention and Control; Surgical Site Infection (SSI)

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Conventional closure

This cohort includes patients who underwent midline abdominal fascial closure using the conventional closure technique as part of routine surgical practice. In this technique, the fascia was closed with continuous suturing using wider and deeper bites of the fascial edges and greater spacing between stitches compared with the small-bite approach. Closure was typically performed with a loop or single-strand absorbable monofilament suture and a larger needle, in accordance with traditional standards commonly applied in abdominal surgery.

The choice of conventional closure was not randomized and reflected the operating surgeon's preference, intraoperative judgment, and case characteristics, such as incision length, wound conditions, and surgical urgency. This cohort therefore represents real-world clinical practice across a broad spectrum of elective and emergency abdominal procedures.

No experimental intervention was assigned to this group. All other aspects of perioperative managemen

No interventions assigned to this group

Small-bite closure

This cohort includes patients who underwent midline abdominal fascial closure using the small-bite closure technique as part of routine surgical practice. In this technique, the fascia was closed with a continuous suture using small, closely spaced bites taken a short distance from the fascial edge, resulting in a higher suture-to-wound length ratio compared with conventional closure. An absorbable monofilament suture and a smaller needle were used, and stitches were placed at short intervals to achieve uniform tension distribution along the incision line.

The selection of the small-bite technique was not randomized and depended on the operating surgeon's preference and intraoperative assessment. Prior to the initiation of the study, surgeons were familiar with and trained in the application of this technique, ensuring consistent execution within routine clinical practice. The cohort includes patients undergoing both elective and emergency abdominal procedures, reflecting everyday su

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Muğla Sıtkı Koçman University

OTHER

Sponsor Role: lead

Responsible Party

Ilgaz Kayılıoğlu

Faculty Member

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Muğla Sıtkı Koçman Research and Training Hospital

Muğla, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

06052021-10/I

Identifier Type: -

Identifier Source: org_study_id