Risk Factors for Development of Incisional Hernia in Transverse Incisions

NCT03561727 | Unknown DMC

• 2 other identifiers: 1WB1/3D1792017/26/D/NZ5/00733
• Study Type: interventional
• Target: 392
• Locations: 1 country
• Sites: 1

Brief Summary

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

Incisional Hernia; Malignancy

Keywords

incisional hernia; malignancy; transverse incision; abdominal closure; surgical technique; insicion; surgery

Outcome Measures

Primary Outcomes (1)

• Incisional hernia

  Development of burst abdomen in the immediate postoperative period (until discharge from hospital) or incisional hernia over a 2-year follow-up period (combined end-point). The follow-up protocol used for the assessment of incisional hernias at discharge from hospital and two control visits at 1 and 2 years postoperatively.

  2 years

Secondary Outcomes (4)

• Quality of life

  2 years

• Surgical site infection

  90 days

• Severe postoperative morbidity

  90 days

• Duration of hospitalization

  90 days

Study Arms (2)

Mass closure technique

EXPERIMENTAL

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.

Procedure: Mass closure technique

Layered closure technique

ACTIVE COMPARATOR

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.

Procedure: Layered closure technique

Interventions

Mass closure technique PROCEDURE

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.

Mass closure technique

Layered closure technique PROCEDURE

he first layer will include peritoneum, transversalis fascia and posterior layer of the rectus abdominis muscle fascia closed with 2 continuous sutures beginning at both ends of the wound. In case of incisions exceeding the lateral border of rectus abdominis muscle, the second layer of the continuous suture will start at the lateral border of rectus abdominis muscle, process laterally to the lateral end of the wound involving internal oblique abdominal muscle fascia. Subsequently, the suture will be led out on the anterior surface of the external oblique abdominal muscle, put through by the created loop in the medial direction and processed medially to close the external oblique abdominal muscle fascia and anterior layer of the rectus abdominis muscle fascia.

Layered closure technique

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Warsaw: lead
• National Science Centre, Poland: collaborator

Study Sites (1)

Department of General, Transplant and Liver Surgery

Warsaw, Masovian Voivodeship, 02-097, Poland

RECRUITING

Related Publications (1)

• Grat 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 DERIVED

MeSH Terms

Conditions

Incisional Hernia; Neoplasms

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Officials

• Michał Grąt, MD, PhD

  Department of General, Transplant and Liver Surgery, Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michał Grąt, MD, PhD

CONTACT

+48225992541; michal.grat@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Neither the patients included in the study nor the investigators assessing the presence of incisional hernia during follow-up visits will be aware of the type of surgical technique used for abdominal closure (double-blinded study). Only the professionals present in the operating room during surgical procedure, including operator, assistants, anesthesiologist, and nurses, will be aware of the type of assigned intervention.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The technique comprising continuous suture and mass closure will be compared to the technique 2 separate layers of continuous sutures. Patients will be randomly assigned to one of the two techniques of abdominal closure during the operative procedure and after its main part has been completed, just before the beginning of closure of the abdominal cavity. Randomization will be performed in a 1:1 ratio and in blocks of 20 patients.

Study Record Dates

• First Submitted: May 28, 2018
• First Posted: June 19, 2018
• Study Start: September 1, 2018
• Primary Completion: May 30, 2021
• Study Completion: May 30, 2021
• Last Updated: November 3, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)