Clinical trial · Interventional
Risk Factors for Development of Incisional Hernia in Transverse Incisions
Study on the Risk of Incisional Hernia Development Following Transverse Epigastric Incisions in Patients Operated for Malignant Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RESEARCH PROJECT OBJECTIVES The aim of this planned study is to evaluate factors, with particular reference to surgical technique of abdominal closure, accumulation of advanced glycation end products, and collagen content in the transversalis fascia, that are associated with the development of incisional hernias after transverse epigastric incisions in patients operated due to malignant tumors. RESEARCH PROJECT METHODOLOGY: The study is designed as prospective and is planned to include 392 patients undergoing abdominal surgery due to malignant tumors of the alimentary system performed through transverse incisions in the epigastrium. Primary end-point of the study is defined as the occurrence of burst abdomen during immediate postoperative period or incisional hernia over 2 year postoperative follow-up. Assessment of the association between the type of surgical technique and development of hernia will be based on comparison of mass (1 layer) continuous suture and layered (2 layers) continuous suture using slowly absorbable material and applying suture to wound length ratio of more than 4. Type of the utilized surgical technique will be based on randomization. The method of abdominal closure will remain unknown for patients and investigators assessing the presence of incisional hernias. Assessment of overall collagen content and type I to type III ratio will be performed by obtaining a fragment of tissue during operation, preparation of formalin-fixed and paraffin embedded blocks, cutting of 4-micrometer thick sections, staining with picrosirius red and immunohistochemical procedures. Images will be analyzed with dedicated computer software. Accumulation of advanced glycation end products will be evaluated indirectly by measuring skin autofluorescence utilizing a method based on the use of photodiodes. Postoperative follow-up will include the period of postoperative hospitalization and two additional control visits at 1 and 2 years after the operation. Assessment of the presence of incisional hernia will comprise clinical examination, ultrasonographical study, and analysis of images from other available radiological studies. Irrespective of the primary end-point, additional analyses will be performed concerning associations between evaluated factors and occurrence of burst abdomen and the impact of incisional hernia on patients quality of life using the EORTC QLQ C-30 questionnaires. Statistical analyses will, among other, include Kaplan-Meier method, log-rank test, Cox proportional hazards regression and logistic regression
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Incisional Hernia | — | UNRESOLVED | — |
| Malignancy | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Layered closure technique | Procedure | — | UNRESOLVED |
| Mass closure technique | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Mass closure technique
- description
- Abdominal cavity will be closed by a single layer of 2 continuous sutures beginning on the opposite ends of the wound towards the median line and involving peritoneum, transversalis fascia, posterior and anterior layer of rectus abdominis muscle fascia and, in case of incisions beyond the lateral border of rectus abdominis muscle, also the oblique abdominal muscles fascia.
- interventionNames
- Procedure: Mass closure technique
- type
- ACTIVE_COMPARATOR
- label
- Layered closure technique
- description
- Abdominal cavity will be closed with two separate layers of continuous sutures. The first layer will include peritoneum, transversalis fascia and posterior layer of the rectus abdominis muscle fascia. In case of incisions not exceeding the lateral border of rectus abdominis muscle, the second layer will involve only the anterior layer of the rectus abdominis muscle fascia. In case of incisions exceeding the lateral border of rectus abdominis muscle, the second layer will include internal oblique abdominal muscle fascia, external oblique abdominal muscle fascia and anterior layer of the rectus abdominis muscle fascia.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * scheduled operative treatment due to malignant tumor of the alimentary system (including liver, bile ducts, and pancreas) through transverse incision in the epigastric region * provision of informed consent to participate in the study Exclusion Criteria: * necessity to perform an urgent operation * a history of previous surgery performed with transverse incision in the epigastric region * body mass index \>35 kg/m2
References
Publications (1)
- DERIVEDGrat M, Morawski M, Krasnodebski M, Borkowski J, Krawczyk P, Grat K, Stypulkowski J, Maczkowski B, Figiel W, Lewandowski Z, Kobryn K, Patkowski W, Krawczyk M, Wroblewski T, Otto W, Paluszkiewicz R, Zieniewicz K. Incisional Surgical Site Infections After Mass and Layered Closure of Upper Abdominal Transverse Incisions: First Results of a Randomized Controlled Trial. Ann Surg. 2021 Nov 1;274(5):690-697. doi: 10.1097/SLA.0000000000005128. PMID 34353985