Cytokine Response to Abdominal Wall Reconstruction

NCT07422584 | Recruiting

• 1 other identifier: STU00225446
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, observational translational study of patients undergoing major abdominal wall reconstruction with primary fascial closure. The project integrates perioperative cytokine profiling, direct measurement of intra-abdominal pressure, and detailed clinical outcomes to define the biologic and physiologic consequences of high-tension closure. The study includes three cohorts: 1) Healthy controls (N=5), 2) High-tension fascial closure AWR patients (N=10), 3) Low-tension fascial closure AWR patients (N=10). Fascial closure tension will not be altered for the purpose of the study and will be determined by the operating surgeon as part of routine clinical decision-making.

Conditions

Incisional Ventral Hernia

Outcome Measures

Primary Outcomes (1)

• Determine whether fascial closure tension correlates with systemic and peritoneal fluid cytokine activation.

  Blood and peritoneal fluid will be collected at baseline (intra-operative), immediately following fascial closure and on postoperative days 1, 3, and 5. Serum cytokine concentrations of GM-CSF, IFN-gamma, IL-1, IL-2, IL-5, IL-6, IL-8, and TNF-alpha (inflammatory); IL-4 and IL-10 (anti-inflammatory) will be measured via multiplex immunoassays (Luminex). Cytokine area under the curve will also be calculated to allow analysis of total cytokine exposure over time.

  Baseline through postoperative day 5

Secondary Outcomes (9)

• Differences in peripheral blood mononuclear cells and peritoneal macrophage transcriptomic signatures via bulk RNA sequencing between baseline profiles from healthy control subjects, high-tension and low-tension abdominal wall closures.

  Baseline through postoperative day 5

• Differences in peak intra-abdominal values, intra-abdominal hypertension grading, abdominal perfusion pressure, plateau pressure between baseline profiles from healthy control subjects, high-tension and low-tension abdominal wall closures.

  Baseline through postoperative day 5

• Incidence of respiratory compromise

  From surgery through hospital discharge (up to 30 days)

• Incidence of acute kidney injury

  From surgery through hospital discharge (up to 30 days)

• Incidence of vasopressor use

  From surgery through hospital discharge (up to 30 days)

Study Arms (3)

High tension group

Massive incisional ventral hernias with loss of domain undergoing open ventral hernia repair with transversus abdominis release with placement of mesh and closure of fascia under high tension.

Other: Not applicable- observational study

Low tension group

Incisional ventral hernias undergoing open ventral hernia repair with transversus abdominis release with placement of mesh and closure of fascia under low tension.

Other: Not applicable- observational study

Control

Healthy human subjects

Interventions

Not applicable- observational study OTHER

There are no interventions in this observational study.

High tension group; Low tension group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will include adult patients undergoing elective major abdominal wall reconstruction at Northwestern Memorial Hospital. Patients with large ventral hernias requiring component separation and anticipated primary fascial closure will be eligible.

You may qualify if:

• Surgical Participants
• Adults aged 18 years or older
• Scheduled to undergo open retromuscular ventral hernia repair
• Able to provide written informed consent Healthy Control Participants
• Adults aged 18 years or older
• No known inflammatory, autoimmune, or immunologic disease
• Able to provide written informed consent

You may not qualify if:

• Emergent or urgent cases
• Pregnancy
• Chronic systemic steroid use or immunosuppressive therapy
• Active infection at the time of enrollment
• Known autoimmune or inflammatory disease
• End-stage organ failure
• Abdominal surgery within the preceding 60 days

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

RECRUITING

Related Publications (8)

• Rettig TC, Verwijmeren L, Dijkstra IM, Boerma D, van de Garde EM, Noordzij PG. Postoperative Interleukin-6 Level and Early Detection of Complications After Elective Major Abdominal Surgery. Ann Surg. 2016 Jun;263(6):1207-12. doi: 10.1097/SLA.0000000000001342.

  PMID: 26135695 BACKGROUND

• Dimopoulou I, Armaganidis A, Douka E, Mavrou I, Augustatou C, Kopterides P, Lyberopoulos P, Tzanela M, Orfanos SE, Pelekanou E, Kostopanagiotou G, Macheras A, Giamarellos-Bourboulis EJ. Tumour necrosis factor-alpha (TNFalpha) and interleukin-10 are crucial mediators in post-operative systemic inflammatory response and determine the occurrence of complications after major abdominal surgery. Cytokine. 2007 Jan;37(1):55-61. doi: 10.1016/j.cyto.2007.02.023. Epub 2007 Apr 10.

  PMID: 17428673 BACKGROUND

• Jansson K, Redler B, Truedsson L, Magnuson A, Matthiessen P, Andersson M, Norgren L. Intraperitoneal cytokine response after major surgery: higher postoperative intraperitoneal versus systemic cytokine levels suggest the gastrointestinal tract as the major source of the postoperative inflammatory reaction. Am J Surg. 2004 Mar;187(3):372-7. doi: 10.1016/j.amjsurg.2003.12.019.

  PMID: 15006565 BACKGROUND

• Badia JM, Whawell SA, Scott-Coombes DM, Abel PD, Williamson RC, Thompson JN. Peritoneal and systemic cytokine response to laparotomy. Br J Surg. 1996 Mar;83(3):347-8. doi: 10.1002/bjs.1800830316. No abstract available.

  PMID: 8665188 BACKGROUND

• Sido B, Teklote JR, Hartel M, Friess H, Buchler MW. Inflammatory response after abdominal surgery. Best Pract Res Clin Anaesthesiol. 2004 Sep;18(3):439-54. doi: 10.1016/j.bpa.2003.12.006.

  PMID: 15212338 BACKGROUND

• Li R, Ye JJ, Gan L, Zhang M, Sun D, Li Y, Wang T, Chang P. Traumatic inflammatory response: pathophysiological role and clinical value of cytokines. Eur J Trauma Emerg Surg. 2024 Aug;50(4):1313-1330. doi: 10.1007/s00068-023-02388-5. Epub 2023 Dec 27.

  PMID: 38151578 BACKGROUND

• Blatnik JA, Krpata DM, Pesa NL, Will P, Harth KC, Novitsky YW, Rowbottom JR, Rosen MJ. Predicting severe postoperative respiratory complications following abdominal wall reconstruction. Plast Reconstr Surg. 2012 Oct;130(4):836-841. doi: 10.1097/PRS.0b013e318262f160.

  PMID: 22691844 BACKGROUND

• Petro CC, Raigani S, Fayezizadeh M, Rowbottom JR, Klick JC, Prabhu AS, Novitsky YW, Rosen MJ. Permissible Intraabdominal Hypertension following Complex Abdominal Wall Reconstruction. Plast Reconstr Surg. 2015 Oct;136(4):868-881. doi: 10.1097/PRS.0000000000001621.

  PMID: 26090761 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples Peritoneal fluid samples

Study Officials

• Michael Rosen, MD

  Northwestern University

  STUDY DIRECTOR

Central Study Contacts

Megan Melland-Smith, MD

CONTACT

312-907-1414; megan.mellandsmith@nm.org

Nancy Ly, MD

CONTACT

262-455-1560; nancy.ly@nm.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 20, 2026
• Study Start: February 3, 2026
• Primary Completion (Estimated): February 5, 2027
• Study Completion (Estimated): March 5, 2027
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)