An interventional study of Prophylactic polypropylene onlay mesh in Incisional Hernia After Midline Laparotomy, Quality of Life (QOL) and Burst Abdomen, sponsored by Sykehuset Innlandet HF. Recruiting at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-05.
Sponsored by Sykehuset Innlandet HF · Not applicable, Interventional, and Prevention
A multicenter randomized controlled trial comparing midline laparotomy closures using the small-bite suture technique alone to those using the small-bite suture technique with an additional onlay prophylactic polypropylene mesh. The primary endpoint is the incidence of incisional hernias in both groups after one year.
An incisional hernia (IH) is a defect in the abdominal wall at the site of a surgical scar, leading to the protrusion of abdominal contents through the defect. It is a common complication following midline laparotomy, with incidence rates ranging from 9% to 40% in the general population, and up to 69% in high-risk patients. Several studies have been conducted on the prevention of IH, and one established intervention is the use of a synthetic mesh to reinforce the suture closure of the abdomen after midline laparotomy. However, the use of mesh in this context is not widespread in Norway, and there are no Norwegian studies on IH prevention following midline laparotomy. This study aims to contribute to the broader knowledge base and encourage Norwegian surgeons to consider using prophylactic meshes.
The study will involve three Norwegian hospitals: Hamar Hospital, Gjøvik Hospital, and Lillehammer Hospital. Participants will be patients scheduled for midline laparotomy at these hospitals who consent to participate, meet the inclusion criteria, and do not meet any exclusion criteria. Participants will be randomly assigned to two groups, each receiving a different variation of fascia closure during laparotomy. One group will undergo closure using the standard small-bites technique only, while the other group will undergo closure with the small-bites technique in addition to an onlay polypropylene mesh.
The primary outcome is the occurrence of incisional hernia one year after surgery, identified through clinical examination and CT scan. Additionally, surgical site occurrences (e.g., hematoma, infection, seroma, wound dehiscence) will be recorded four to six weeks post-surgery. Quality of life and pain levels will also be assessed at both four to six weeks and one year after surgery.
745 studies on the registry are indexed under Surgical Wound Infection; 151 are open to participants now.
This study's planned enrollment of 150 is below the median of 200 across 581 interventional studies indexed under Surgical Wound Infection.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The patients in the mesh group are closed with small bites technique and in addition receiving an onlay polypropylene mesh when closing the fascia in midline laparotomies. These patients receive a subcutaneous drain to prevent seroma.
Procedure: Prophylactic polypropylene onlay mesh
The patients in the suture group are closed with small bites technique.
The patients in the mesh group are closed with small bites technique and in addition receiving an onlay polypropylene mesh when closing the fascia in midline laparotomies.
Incisional hernia
Incisional hernia occurrence will be evaluated clinically and by CT examination after 12 months
Time frame: 12 months
Quality of Life
Quality of life will be measured preoperatively for elective patients and after 4-6 weeks and after 1 year for all patients. Quality of life will be measured using 5-level EQ-5D version (EQ-5D-5L) provided by the EuroQol group. The system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Time frame: 4-6 weeks and 1 year
Level of pain
Pain level will be measured preoperatively for elective patients and after 4-6 weeks and after 1 year for all patients. The level will be measured using VAS-scale from 0 to 10 where 0 is explained as "no pain" and 10 is explained as "the worst pain you can possibly imagine".
Time frame: 4-6 weeks and 1 year
Symptomatic surgical site occurrence (SSO)
Symptomatic surgical site occurrence (SSO)when the patient it discharged and after 4-6 weeks. Surgical site occurence including seroma, hematoma, wound dehiscence and infection.
Time frame: 4-6 weeks
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