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Risk Factors for Development of Incisional Hernia in Transverse Incisions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03561727
Recruitment Status : Unknown
Verified December 2019 by Medical University of Warsaw.
Recruitment status was:  Recruiting
First Posted : June 19, 2018
Last Update Posted : November 3, 2020
Sponsor:
Collaborator:
National Science Centre, Poland
Information provided by (Responsible Party):
Medical University of Warsaw

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


Condition or disease Intervention/treatment Phase
Incisional Hernia Malignancy Procedure: Mass closure technique Procedure: Layered closure technique Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 392 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.

Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Prevention
Official Title: Study on the Risk of Incisional Hernia Development Following Transverse Epigastric Incisions in Patients Operated for Malignant Tumors
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : May 30, 2021
Estimated Study Completion Date : May 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
Experimental: Mass closure technique
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
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.

Active Comparator: Layered closure technique
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
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.




Primary Outcome Measures :
  1. Incisional hernia [ Time Frame: 2 years ]
    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.


Secondary Outcome Measures :
  1. Quality of life [ Time Frame: 2 years ]
    Quality of life assessed in EORTC QLQ-C30 questionnaire

  2. Surgical site infection [ Time Frame: 90 days ]
    surgical site infections, defined and classified according to the CDC (Centers for Disease Control) recommendations

  3. Severe postoperative morbidity [ Time Frame: 90 days ]
    Complications of grade III or higher according to Clavien-Dindo classification

  4. Duration of hospitalization [ Time Frame: 90 days ]
    Duration of postoperative hospitalization in days



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03561727


Contacts
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Contact: Michał Grąt, MD, PhD +48225992541 michal.grat@gmail.com

Locations
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Poland
Department of General, Transplant and Liver Surgery Recruiting
Warsaw, Mazowieckie, Poland, 02-097
Contact: Michał Grąt, MD, PhD    +48225992541    michal.grat@gmail.com   
Sponsors and Collaborators
Medical University of Warsaw
National Science Centre, Poland
Investigators
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Principal Investigator: Michał Grąt, MD, PhD Department of General, Transplant and Liver Surgery, Medical University of Warsaw
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT03561727    
Other Study ID Numbers: 1WB1/3D179
2017/26/D/NZ5/00733 ( Other Grant/Funding Number: National Science Centre, Poland )
First Posted: June 19, 2018    Key Record Dates
Last Update Posted: November 3, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medical University of Warsaw:
incisional hernia
malignancy
transverse incision
abdominal closure
surgical technique
insicion
surgery
Additional relevant MeSH terms:
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Neoplasms
Hernia
Incisional Hernia
Pathological Conditions, Anatomical
Postoperative Complications
Pathologic Processes