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OpenTrials
Completed

NCT Number: NCT04562363

Prevention of Postoperative Ventral Hernias

The research is aimed at identifying factors of herniation after median laparotomy and developing surgical methods for preventing postoperative ventral hernias and eventrations.

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Key information

Conditions

Gangrenous Postoperative Ventral Hernia (Diagnosis) Dehiscence of Laparotomy Wound Disease Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

RyazSMU, Ryazan, Ryazan Oblast, Russia

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About this study

At the first stage, an analysis of the prevalence of postoperative ventral hernias in patients after median laparotomies in urgent surgery will be performed, with the identification of factors contributing to the development of postoperative ventral hernias. At the next stage, the investigators will search for the most reliable methods of suturing the white line of the abdomen, taking into account the risk of hernia formation, with their implementation in patients operated in an emergency through median laparotomic access in comparison with traditionally used methods. In conclusion, an algorithm will be developed for selecting the method of surgical prevention of postoperative ventral hernias, taking into account the risk of their development.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients of both sexes aged 18 years and older who are expected to perform median laparotomy on a planned or emergency basis.
  • Patients who have signed an informed consent to participate in the study, after the purpose and meaning of the study have been explained to them.
  • Patients who follow the doctor's instructions.

Exclusion criteria

  • The death of the patient.
  • Stage IV cancer
  • Hernia repair with hernioplasty, including simultaneous surgery
  • Refusal of the patient to cooperate with the researcher.

Treatment and study plan

Suturing of a laparotomic wound with modified methods

Procedure

Suturing the white line of the abdomen with the help of developed techniques aimed at preventing hernias and eventrations

Primary outcomes

  1. Wound complications

    Time frame: 2 weeks

    Frequency of wound complications in the early postoperative period.

  2. Eventration

    Time frame: 2 weeks

    Frequency of events in the early postoperative period

  3. Pain syndrome

    Time frame: 2 year

    The severity of pain syndrome in the postoperative scar after midline laparotomy using a verbal scale of pain syndrome

  4. Postoperative ventral hernia

    Time frame: 2 year

    Frequency of postoperative ventral hernia in the late postoperative period

  5. Defects in the aponeurosis

    Time frame: 2 year

    Frequency of aponeurosis defects in the late postoperative period

Sponsors and collaborators

Lead sponsor

Ryazan State Medical University

Other

Registry information

Official study title

Prevention of Postoperative Ventral Hernias After Median Laparotomy in Urgent Surgery

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Sep 24, 2020
Registry last updated
Feb 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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