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Tirzepatide-Based Prehabilitation Before Elective Ventral and Incisional Hernia Repair in Patients With Obesity:A Prospective Multicenter Cohort Study With a Comparative Control Cohort

5 giugno 2026 aggiornato da: Francesco Pizza, Azienda Sanitaria Locale Napoli 2 Nord
This study evaluated whether a 16-week weight-loss program using tirzepatide before elective ventral and incisional hernia surgery could improve surgical readiness and outcomes in patients with obesity. In this retrospective multicenter study, 109 patients entered the program, and 91 completed treatment and underwent surgery. Participants achieved an average weight loss of 13.8%, and all patients who completed the program reached the target weight required for surgery. Compared with a control group of obese patients who underwent hernia repair without pharmacological prehabilitation, the tirzepatide group experienced fewer postoperative wound-related complications.

Panoramica dello studio

Descrizione dettagliata

This study investigated whether a structured weight-loss program using tirzepatide could improve the condition of patients with obesity before undergoing elective ventral or incisional hernia repair. Obesity is a well-recognized risk factor for hernia formation, postoperative complications, and hernia recurrence, yet many patients struggle to achieve sufficient weight loss through diet and exercise alone. Tirzepatide, a medication that targets both GIP and GLP-1 receptors, has recently shown remarkable effectiveness in promoting weight reduction, but its role as a preoperative optimization strategy in abdominal wall surgery had not previously been evaluated in a prospective multicenter setting.

Researchers conducted a retrospective study across four specialized abdominal wall surgery centers. Adults with obesity (body mass index ≥30 kg/m²) and medium-to-large ventral or incisional hernias scheduled for elective repair were enrolled in a 16-week multidisciplinary prehabilitation program. Participants received weekly tirzepatide injections with gradual dose escalation, together with nutritional counseling and physiotherapy. The goal was to achieve at least 10% total body weight loss or reduce body mass index to 33 kg/m² or lower before surgery. Outcomes were compared with a control cohort of obese patients who had undergone similar hernia repairs without pharmacological prehabilitation.

A total of 109 patients entered the program, and 91 (83.5%) successfully completed the full 16-week course and proceeded to surgery. The average weight loss among completers was 13.8%, with body mass index decreasing from 34.5 kg/m² at enrollment to 27.5 kg/m² at the time of surgery. Importantly, every patient who completed the program reached the predefined preoperative weight target, demonstrating the feasibility and effectiveness of this approach.

The study also examined postoperative outcomes. Patients who underwent tirzepatide-based prehabilitation experienced lower rates of wound-related complications, including seroma formation, surgical site infection, hematoma, mesh infection, and chronic postoperative pain, compared with the control group. Overall surgical site occurrences were reduced from 22.1% in controls to 8.8% in the tirzepatide group. Multivariable analysis confirmed that participation in the tirzepatide program was independently associated with a significantly lower risk of postoperative surgical-site complications.

Treatment was generally well tolerated. Only four patients discontinued therapy because of mild gastrointestinal side effects such as diarrhea or reflux. The most common reason for discontinuation was the financial cost of treatment, highlighting a potential barrier to wider implementation.

Although follow-up remains relatively short and the comparison group was not randomized, these findings suggest that tirzepatide-based prehabilitation may represent an effective strategy for preparing patients with obesity for abdominal wall hernia surgery. By enabling substantial preoperative weight loss and potentially reducing postoperative complications, tirzepatide may help improve surgical outcomes and expand access to elective hernia repair for patients who might otherwise be considered high-risk surgical candidates. Larger studies with longer follow-up are needed to confirm these promising preliminary results.

Tipo di studio

Osservativo

Iscrizione (Effettivo)

91

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

      • Naples, Italia, 80131
        • Francesco Pizza

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

N/A

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Adults (≥ 18 years) with obesity (BMI ≥ 30 kg/m²) and an elective primary ventral or incisional midline hernia of European Hernia Society width W2-W3, amenable to a standard Rives-Stoppa retromuscular repair, managed at four high-volume abdominal wall surgery units. The prospective prehabilitation cohort comprises consecutive eligible patients who agreed to undergo a structured 16-week tirzepatide-based preoperative weight-optimization program before elective repair. The comparative control cohort comprises patients meeting the same age, BMI, hernia type, EHS width, and surgical-technique criteria who underwent elective repair without pharmacologic prehabilitation at the same centers over the preceding five years, identified from prospectively maintained institutional databases. Patients requiring emergency surgery, posterior component separation/transversus abdominis release, or with contraindications to tirzepatide were not included.

Descrizione

Inclusion Criteria:

Age ≥ 18 years Body mass index (BMI) ≥ 30 kg/m² Elective primary ventral or incisional midline hernia European Hernia Society (EHS) width W2 (4-10 cm) or W3 (> 10 cm) Hernia amenable to a standard Rives-Stoppa retromuscular repair Able and willing to comply with the prehabilitation program and scheduled follow-up

Exclusion Criteria:

Emergency presentation or incarcerated/strangulated hernia Contraindication to tirzepatide (personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2; prior pancreatitis; severe gastrointestinal disease; pregnancy or lactation) Ongoing treatment with another anti-obesity medication Prior bariatric surgery within the preceding 12 months Hernia requiring posterior component separation or transversus abdominis release (TAR) Inability to comply with follow-up

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Preoperative Tirzepatide Cohort
Tirzepatide prehabilitation cohort Adults with obesity (BMI ≥ 30 kg/m²) and an elective primary ventral or incisional midline hernia (EHS width W2-W3) amenable to a standard Rives-Stoppa retromuscular repair, prospectively enrolled across four high-volume abdominal wall units. Before surgery, participants undergo a structured 16-week prehabilitation program based on once-weekly subcutaneous tirzepatide, titrated over the period (2.5 mg in month 1, 5 mg in month 2, 7.5 mg in months 3-4), delivered within a multidisciplinary bundle that also includes dietary counseling and physical/respiratory conditioning. The predefined preoperative target is a total weight loss ≥ 10% or a BMI ≤ 33 kg/m². Elective open retromuscular repair is performed once the target is reached and the program is completed.

Once-weekly subcutaneous tirzepatide administered as a structured 16-week preoperative prehabilitation course, with stepwise dose titration: 2.5 mg/week during month 1, 5 mg/week during month 2, and 7.5 mg/week during months 3-4. The drug is delivered within a multidisciplinary prehabilitation bundle (dietary counseling and physical/respiratory conditioning) in patients with obesity (BMI ≥ 30 kg/m²) scheduled for elective ventral or incisional hernia repair. The predefined preoperative goal is a total weight loss ≥ 10% or a BMI ≤ 33 kg/m²; elective open Rives-Stoppa retromuscular repair is performed once the target is reached and the 16-week course is completed. The maximum dose is capped at 7.5 mg/week, and the course is time-limited to the preoperative window rather than continued long term.

What makes this distinct from other tirzepatide interventions (worth keeping in the wording, as the field asks): it is preoperative and time-limited (16 weeks), capped at 7.5 mg (lower than the u

Comparative control cohort
Patients with obesity (BMI ≥ 30 kg/m²) who underwent elective ventral or incisional midline hernia repair (EHS width W2-W3) by the same standard Rives-Stoppa retromuscular technique, without any pharmacologic prehabilitation, at the same four centers over the preceding five years. This cohort was identified retrospectively from the prospectively maintained institutional databases and applied the same age, BMI, hernia type, EHS width, and surgical-technique eligibility criteria as the prehabilitation cohort. It serves as the non-pharmacologic comparison group for perioperative and short-term surgical outcomes.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Feasibility of tirzepatide-based prehabilitation
Lasso di tempo: 16 weeks (from initiation of prehabilitation to surgery)
Proportion of enrolled patients who complete the 16-week tirzepatide prehabilitation program, reach the preoperative target (≥ 10% total weight loss or BMI ≤ 33 kg/m²), and proceed to elective ventral or incisional hernia repair.
16 weeks (from initiation of prehabilitation to surgery)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Preoperative weight optimization
Lasso di tempo: 16 weeks (from initiation of prehabilitation to surgery)
Mean preoperative total weight loss (%) and reduction in BMI from enrollment to surgery, and the proportion of patients reaching the predefined target (≥ 10% total weight loss or BMI ≤ 33 kg/m²).
16 weeks (from initiation of prehabilitation to surgery)
Composite surgical site occurrence
Lasso di tempo: 90 days postoperatively
Proportion of patients with at least one surgical site occurrence (seroma, surgical site infection, hematoma, or mesh infection) after elective hernia repair.
90 days postoperatively
Postoperative morbidity by Clavien-Dindo classification
Lasso di tempo: 90 days postoperatively
Severity of postoperative complications graded according to the Clavien-Dindo classification.
90 days postoperatively

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 gennaio 2025

Completamento primario (Effettivo)

1 giugno 2026

Completamento dello studio (Effettivo)

1 giugno 2026

Date di iscrizione allo studio

Primo inviato

5 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

5 giugno 2026

Primo Inserito (Effettivo)

10 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

De-identified individual participant data underlying the results reported in the primary publication, together with the data dictionary, will be made available to investigators whose proposed use is approved by the study steering committee, for analyses aimed at achieving the aims of the approved proposal. Data will be available after publication with no planned end date; requests should be directed to the corresponding author and will require a signed data-access agreement.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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