Tirzepatide-Based Prehabilitation Before Elective Ventral and Incisional Hernia Repair in Patients With Obesity

NCT07638592 | Completed DMC FDA Drug

• 1 other identifier: 2128112026
• Study Type: observational
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obese Adults; Prehabilitation; Hernia Abdominal Wall

Keywords

Weight loss; Multidisciplinary care; Surgical site complications

Outcome Measures

Primary Outcomes (1)

• 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.

  16 weeks (from initiation of prehabilitation to surgery)

Secondary Outcomes (3)

• Preoperative weight optimization

  16 weeks (from initiation of prehabilitation to surgery)

• Composite surgical site occurrence

  90 days postoperatively

• Postoperative morbidity by Clavien-Dindo classification

  90 days postoperatively

Study Arms (2)

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.

Drug: Tirzepatide prehabilitation

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.

Interventions

Tirzepatide prehabilitation DRUG

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

Preoperative Tirzepatide Cohort

Eligibility Criteria

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

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Sanitaria Locale Napoli 2 Nord: lead

Study Sites (1)

Francesco Pizza

Naples, 80131, Italy

Location

MeSH Terms

Conditions

Hernia, Abdominal; Weight Loss

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Body Weight; Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 10, 2026
• Study Start: January 1, 2025
• Primary Completion: June 1, 2026
• Study Completion: June 1, 2026
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)