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

NCT07340918 | Completed

• 1 other identifier: 06052021-10/I
• Study Type: observational
• Target: 217
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

incisional hernia; abdominal surgical procedures; wound closure techniques; postoperative complications

Outcome Measures

Primary Outcomes (1)

• Incisional Hernia

  The primary outcome measure was the occurrence of incisional hernia after midline abdominal surgery. Incisional hernia was defined as a postoperative defect of the abdominal wall at the site of the surgical incision, with or without a clinically visible or palpable bulge. All participants were followed prospectively using a standardized follow-up protocol. Assessment for incisional hernia was performed at 12 months after the index operation. Evaluation included a structured physical examination of the abdominal wall conducted by the study investigators. To increase diagnostic accuracy and to detect both clinically evident and subclinical hernias, all patients also underwent ultrasonographic examination of the incision site. The outcome was recorded as a binary variable (presence or absence of incisional hernia). Only hernias confirmed by clinical assessment and imaging were considered events. The time frame for outcome assessment was up to 12 months postoperatively.

  12 months

Secondary Outcomes (1)

• Early postoperative complications

  1 month

Study Arms (2)

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consisted of adult patients undergoing midline abdominal surgery at a tertiary referral general surgery center in Muğla. Participants were recruited consecutively from routine clinical practice and included individuals treated for a wide range of benign and malignant abdominal conditions. Both elective and emergency procedures were represented, reflecting the full spectrum of surgical activity at the study center. All operations were performed by experienced general surgeons using standardized perioperative care protocols. The population therefore represents a real-world cohort of patients treated in a high-volume surgical unit, encompassing variability in surgical urgency, wound conditions, and case complexity. Patients were followed prospectively within the same institution using a standardized postoperative and long-term follow-up program.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Muğla Sıtkı Koçman University: lead

Study Sites (1)

Muğla Sıtkı Koçman Research and Training Hospital

Muğla, 48000, Turkey (Türkiye)

Location

Related Publications (1)

• Tanriverdi E, Sahin S, Yazkan C, Dere O, Ozcan O, Kayilioglu I. Small-bite versus conventional midline fascial closure in abdominal surgery: a prospective observational cohort study. BMC Surg. 2026 Jan 24;26(1):145. doi: 10.1186/s12893-026-03530-x.

  PMID: 41580707 DERIVED

MeSH Terms

Conditions

Incisional Hernia; Surgical Wound Infection; Postoperative Complications

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Wound Infection; Infections

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Faculty Member

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: January 14, 2026
• Study Start: May 1, 2021
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

TU (1)