An observational study in Obese Adults, Hernia Abdominal Wall and Prehabilitation, sponsored by Azienda Sanitaria Locale Napoli 2 Nord. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-11.
Sponsored by Azienda Sanitaria Locale Napoli 2 Nord · Observational
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.
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.
82 studies on the registry are indexed under Hernia, Abdominal; 19 are open to participants now.
This study's enrollment of 91 is below the median of 115 across 29 observational studies indexed under Hernia, Abdominal.
Browse Hernia, Abdominal studies →Azienda Sanitaria Locale Napoli 2 Nord is the lead sponsor of 16 studies on the registry; 3 are open to participants now.
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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.
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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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Tirzepatide prehabilitation
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.
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
This study also gives Tirzepatide. No intervention listed here names it: that was found by reading the record.
Feasibility of tirzepatide-based prehabilitation
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.
Time frame: 16 weeks (from initiation of prehabilitation to surgery)
Preoperative weight optimization
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).
Time frame: 16 weeks (from initiation of prehabilitation to surgery)
Composite surgical site occurrence
Proportion of patients with at least one surgical site occurrence (seroma, surgical site infection, hematoma, or mesh infection) after elective hernia repair.
Time frame: 90 days postoperatively
Postoperative morbidity by Clavien-Dindo classification
Severity of postoperative complications graded according to the Clavien-Dindo classification.
Time frame: 90 days postoperatively
Plan to share: No — 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.
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Ran from Jan 2025 to primary completion in Jun 2026, 17 months.
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Azienda Sanitaria Locale Napoli 2 Nord