- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07638592
Tirzepatide-Based Prehabilitation Before Elective Ventral and Incisional Hernia Repair in Patients With Obesity
Tirzepatide-Based Prehabilitation Before Elective Ventral and Incisional Hernia Repair in Patients With Obesity:A Prospective Multicenter Cohort Study With a Comparative Control Cohort
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Naples, 이탈리아, 80131
- Francesco Pizza
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참여기준
자격 기준
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샘플링 방법
연구 인구
설명
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
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디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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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.
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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 |
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Feasibility of tirzepatide-based prehabilitation
기간: 16 weeks (from initiation of prehabilitation to surgery)
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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.
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16 weeks (from initiation of prehabilitation to surgery)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Preoperative weight optimization
기간: 16 weeks (from initiation of prehabilitation to surgery)
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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).
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16 weeks (from initiation of prehabilitation to surgery)
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Composite surgical site occurrence
기간: 90 days postoperatively
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Proportion of patients with at least one surgical site occurrence (seroma, surgical site infection, hematoma, or mesh infection) after elective hernia repair.
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90 days postoperatively
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Postoperative morbidity by Clavien-Dindo classification
기간: 90 days postoperatively
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Severity of postoperative complications graded according to the Clavien-Dindo classification.
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90 days postoperatively
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