Standard Closure vs. Integrated Mesh-Fascial Closure (IMFC) for Incisional Hernia Repair (IMFC)
Prospective Comparative Evaluation of the Integrated Mesh-Fascial Closure (IMFC) Technique Versus Standard Closure of the Abdominal Wall: A Quasi-Experimental, Non-Randomized Study
This study compares two surgical techniques for closing the abdominal wall in adult patients who have an incisional hernia (a weakness or opening in a previous surgical incision) or who require prophylactic mesh placement during a laparotomy.
In one group, the abdominal wall is closed using the standard technique, in which a polypropylene mesh is fixed independently from the fascial suture. In the other group, Integrated Mesh-Fascial Closure (IMFC) is used, a standardized execution of the technique of mesh incorporation into the fascial closure described by Jamal et al (Hernia, 2013).
The choice of technique is made by the patient after receiving information about both options and providing informed consent. Participants will be followed clinically and with imaging for 18 to 24 months to evaluate the safety, technical feasibility, and reproducibility of the IMFC technique, and to determine the incidence of hernia recurrence in both groups.
연구 개요
상태
상세 설명
Incisional hernia is one of the most frequent complications of abdominal surgery, with a reported incidence of 10-20% after laparotomy, and recurrence rates after mesh repair reaching 20-30% in long-term follow-up. In conventional techniques, primary fascial closure and mesh fixation are performed as two mechanically independent steps, concentrating tension on the suture line during the acute postoperative period.
The Integrated Mesh-Fascial Closure (IMFC) technique integrates a macroporous polypropylene mesh within a continuous fascial suture line (pattern: mesh → right fascial edge → left fascial edge → mesh), aiming to distribute tensile load simultaneously between the fascia and the prosthesis, potentially reducing the incidence of hernia recurrence compared to standard closure. The principle of incorporating the mesh into the fascial closure was described by Jamal et al in a retrospective series of 72 patients. IMFC standardizes its execution (suture material, 5-mm bites in mesh and fascia, anchoring of the suture line in healthy aponeurosis, and optional minimal peripheral fixation) and evaluates it prospectively against standard closure.
This is a prospective, comparative, quasi-experimental (non-randomized) study conducted at a single center (Hospital Zonal General de Agudos "Dr. Mario V. Larrain," Berisso, Argentina). Eligible patients choose, after informed consent, between standard mesh closure (Group A) or IMFC (Group B). Both groups follow the same clinical and imaging follow-up schedule (days 7, 15, 30; months 2, 6, 12, 18; and a final visit between 18 and 24 months).
The study is designed as an initial, hypothesis-generating comparison of safety, technical feasibility, and reproducibility across surgeons, intended to support a future randomized trial.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Facundo B Mattano, MD
- 전화번호: +54 9 221 611-7976
- 이메일: mattanofacundo@outlook.com
연구 연락처 백업
- 이름: Emiliano D Gargiulo, MD
- 전화번호: +54 2215371371
연구 장소
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Buenos Aires
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Berisso, Buenos Aires, 아르헨티나, 1923
- 모병
- Hospital Zonal General de Agudos "Dr. Mario V. Larrain
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연락하다:
- Facundo B Mattano, MD
- 전화번호: +54 9 2216117976
- 이메일: mattanofacundo@outlook.com
-
연락하다:
- Emiliano D Gargiulo, MD
- 전화번호: +54 9 221 5371371
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Adults older than 18 years of age
- Patients with incisional (ventral) hernia
- Patients with recurrent incisional hernia
- Incisional hernias with a diameter greater than 4 cm
- Patients undergoing laparotomy with an indication for prophylactic mesh placement
Exclusion Criteria:
- Active surgical site infection
- Overt abdominal contamination
- Tissue necrosis or inability to achieve primary fascial closure
- Non-correctable loss of domain
- Pregnant women or women of childbearing potential planning pregnancy or not using contraception during the follow-up period
- Patients belonging to vulnerable populations, in accordance with Law 15.462 and applicable ethical guidelines
- Active oncologic disease (patients with a cured oncologic history may be included)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Standard Mesh Closure
Conventional fascial closure using a macroporous polypropylene mesh fixed independently from the closure suture |
Macroporous polypropylene mesh (FILAPROP™/MERIGROW™) plus non-absorbable polypropylene suture, placed using the conventional (independent) technique. |
|
실험적: Integrated Mesh-Fascial Closure - IMFC
Fascial closure using the Integrated Mesh-Fascial Closure (IMFC) technique: the mesh is incorporated within the trajectory of a single continuous fascial suture (pattern: mesh → right fascial edge → left fascial edge → mesh |
Same materials integrated into a single continuous suture line using the IMFC technique. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Recurrence rate of incisional hernia
기간: 18-24 months (final follow-up visit)
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Proportion of participants with hernia recurrence, assessed by clinical physical examination and abdominal wall ultrasound, performed in all participants at 6 months and at the final visit (18-24 months). All ultrasound evaluations performed by the same sonographer throughout the study; the sonographer is aware of study participation but blinded to the specific surgical technique (IMFC vs. standard closure) received by each participant. |
18-24 months (final follow-up visit)
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Rate of Major Intraoperative and Postoperative Complications
기간: Throughout study participation (up to 24 months)
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Proportion of participants experiencing a serious adverse event (SAE), defined per ICH E6(R3) as death, a life-threatening event, hospitalization or prolongation of hospitalization, persistent or significant disability, or an unplanned surgical reintervention. Postoperative complications additionally graded using the Clavien-Dindo classification system (Grade I-V) to assess severity. |
Throughout study participation (up to 24 months)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Operative time and fascial closure time
기간: Intraoperative (during the surgical procedure)
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Total operative time (from skin incision to skin closure) and fascial closure time (from start to completion of the mesh-fascial suture line), both measured in minutes and recorded intraoperatively by the surgical team using the operating room clock. |
Intraoperative (during the surgical procedure)
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Postoperative Pain Assessed by the 0-10 Numeric Pain Rating Scale (NRS-11)
기간: Postoperative days 7, 15, and 30
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Self-reported postoperative pain intensity measured using the 11-point Numeric Pain Rating Scale (NRS-11), an unabbreviated verbally- or visually-administered numeric scale ranging from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst pain imaginable." Higher scores indicate worse (more severe) pain. Assessed at rest. |
Postoperative days 7, 15, and 30
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Rate of Early Postoperative Complications (Infection, Seroma, Dehiscence, Hematoma)
기간: Up to 30 days postoperative
|
Proportion of participants with surgical site infection, seroma, wound dehiscence, or hematoma, identified by clinical examination at scheduled postoperative visits (days 7, 15, and 30) and graded according to the Clavien-Dindo classification. |
Up to 30 days postoperative
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Total Direct Hospital Costs (ARS) Associated with Complications or Reoperations
기간: Up to 24 months (exploratory)
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Total direct hospital costs, expressed in Argentine pesos (ARS), attributable to management of complications or unplanned reoperations, extracted from institutional administrative and billing records. Exploratory outcome; not powered for formal statistical comparison between groups. |
Up to 24 months (exploratory)
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공동 작업자 및 조사자
수사관
- 수석 연구원: Facundo B Mattano, MD, Hospital Zonal General de Agudos "Dr. Mario V. Larrain
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- IMFC-HL-2026
- DISPO-2026-226-GDEBA-DIYCTMSAL (기타 식별자: Comisión Conjunta de Investigaciones en Salud (CCIS))
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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