Prevention of Postoperative Ventral Hernias

Dehiscence of Laparotomy Wound Clinical Trial

Official title:

Prevention of Postoperative Ventral Hernias After Median Laparotomy in Urgent Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04562363
• Other study ID #: POVG12122021
• Status: Completed
• Start date: December 12, 2018
• Est. completion date: December 12, 2021

Study information

• Verified date: October 2021
• Source: Ryazan State Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: December 12, 2021
• Est. primary completion date: December 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Patients of both sexes aged 18 years and older who are expected to perform median laparotomy on a planned or emergency basis.

2. 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.

3. Patients who follow the doctor's instructions.

Exclusion Criteria:

1. The death of the patient.

2. Stage IV cancer

3. Hernia repair with hernioplasty, including simultaneous surgery

4. Refusal of the patient to cooperate with the researcher.

Related Conditions & MeSH terms

• Dehiscence of Laparotomy Wound
• Gangrenous Postoperative Ventral Hernia (Diagnosis)
• Hernia
• Hernia, Ventral

Intervention

Procedure:
• Suturing of a laparotomic wound with modified methods
Suturing the white line of the abdomen with the help of developed techniques aimed at preventing hernias and eventrations

Locations

Country	Name	City	State
Russian Federation	RyazSMU	Ryazan	Ryazan Region
Russian Federation	RyazSMU	Ryazan

Sponsors (1)

Lead Sponsor	Collaborator
Ryazan State Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound complications	Frequency of wound complications in the early postoperative period.	2 weeks
Primary	Eventration	Frequency of events in the early postoperative period	2 weeks
Primary	Pain syndrome	The severity of pain syndrome in the postoperative scar after midline laparotomy using a verbal scale of pain syndrome	2 year
Primary	Postoperative ventral hernia	Frequency of postoperative ventral hernia in the late postoperative period	2 year
Primary	Defects in the aponeurosis	Frequency of aponeurosis defects in the late postoperative period	2 year