Prophylactic Onlay Mesh versus Suture Only (PROMSO Trial) – Reduction of Incisional Hernia Incidence After Open Abdominal Surgery Through Implantation of a Prophylactic Alloplastic Mesh in Onlay Position

Prophylactic Onlay Mesh versus Suture Only (PROMSO Trial) – Reduction of Incisional Hernia Incidence After Open Abdominal Surgery Through Implantation of a Prophylactic Alloplastic Mesh in Onlay Position - PROMSO

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00039305

Enrollment

522

Registered

2026-06-15

Start date

2026-07-01

Completion date

Unknown

Last updated

2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Incisional hernia

Interventions

Group 1: Intervention group (prophylactic onlay mesh implantation): After completion of open abdomen treatment, a complete tension-free fascial closure is performed using a continuous, long-term absor

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Written informed consent for study participation provided by the patient or, if the patient is temporarily incapable of consent, by a legal representative. Age = 18 years. Open abdomen treatment (laparostomy) following a complete midline laparotomy (from the xiphoid to at least 5 cm above the symphysis). Planned complete tension-free fascial closure along the entire length of the incision.

Exclusion criteria

Exclusion criteria: Lack of informed consent for study participation. Incomplete fascial closure. Wound class CDC III or IV. Septic intra-abdominal process or peritonitis as the indication for open abdomen treatment (laparostomy).

Design outcomes

Primary

Measure	Time frame
The primary outcome of the study is the incidence of incisional hernia within 24 months after complete abdominal wall closure following open abdomen treatment. The diagnosis of incisional hernia is established during clinical follow-up examination and confirmed by ultrasound.	—

Secondary

Measure	Time frame
The secondary outcomes of the study include: Incidence of incisional hernia after 5 years. Occurrence of postoperative complications after fascial closure, including surgical site infections according to the Centers for Disease Control and Prevention (CDC) criteria, seroma or hematoma formation, need for invasive or surgical intervention, and occurrence of enteroatmospheric fistula. Classification of postoperative complications according to the Clavien–Dindo classification. Pain intensity assessed using the patient-reported Numeric Rating Scale (NRS, 0–10). Evaluation of the cosmetic outcome using the Vancouver Scar Scale and the Patient and Observer Scar Assessment Scale (POSAS). Time to return to work (days from surgery until full return to occupational activity). Health-related quality of life assessed using patient-reported questionnaires (SF-36, EQ-5D-3L, and HerQLes score).	—

Measure

Time frame

The secondary outcomes of the study include: Incidence of incisional hernia after 5 years. Occurrence of postoperative complications after fascial closure, including surgical site infections according to the Centers for Disease Control and Prevention (CDC) criteria, seroma or hematoma formation, need for invasive or surgical intervention, and occurrence of enteroatmospheric fistula. Classification of postoperative complications according to the Clavien–Dindo classification. Pain intensity assessed using the patient-reported Numeric Rating Scale (NRS, 0–10). Evaluation of the cosmetic outcome using the Vancouver Scar Scale and the Patient and Observer Scar Assessment Scale (POSAS). Time to return to work (days from surgery until full return to occupational activity). Health-related quality of life assessed using patient-reported questionnaires (SF-36, EQ-5D-3L, and HerQLes score).

—

Countries

Germany

Contacts

Public ContactArnulf Willms

Bundeswehrzentralkrankenhaus Koblenz, Klinik für Allgemein-, Viszeral- und Thoraxchirurgie

bwzkrhskoblenzklinikII@bundeswehr.org+4926128122001

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 29, 2026