Tirzepatide-Based Prehabilitation Before Elective Ventral and Incisional Hernia Repair in Patients With Obesity:A Prospective Multicenter Cohort Study With a Comparative Control Cohort
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 91
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Tirzepatide prehabilitation (Drug)
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.
研究者
Francesco Pizza
Principal Investigator,
Azienda Sanitaria Locale Napoli 2 Nord
