Prospective Study of Minimally Invasive Hernia Repair
Conditions: Ventral Hernia Midline, Hernia Lumbar, Incisional Hernia Repair
Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

PROMISER Registry
Version 3, March 9, 2026
“PROspective study of MInimally invaSIve abdominal wall hERnia repair”
Protocol Code: PROMISER2026
[REDACTED NAME]
General and Digestive Surgery. Fundación Jiménez Díaz
CONTENTS
1 Summary
2 Introduction and Study Justification
3 Hypothesis and Study Objectives
4 Study Type and Design
5 Subject Selection
6 Study Development and Evaluation of Results
7 Adverse Event Management
8 Ethical Aspects
9 Practical Considerations
10 Statistical Analysis
11 Study Publication
12 Bibliography
SUMMARY
Study Identification
Title:
Prospective study of minimally invasive abdominal wall hernia repair
Code: PROMISER
Version: January 1, 2026
Sponsor:
Research Institute of Fundación Jiménez Díaz, Madrid.
Research Team Responsible:

Principal Investigators:
- [REDACTED NAME]
- [REDACTED NAME]
Co-investigators:
- [REDACTED NAME]
- [REDACTED NAME]
- [REDACTED NAME]
- [REDACTED NAME]
Study Centers:
Hospital Universitario Fundación Jiménez Díaz
Ethics Committee:
CEIm of Hospital Universitario Fundación Jiménez Díaz
OBJECTIVES
Primary Objective:
To investigate the recurrence rate of hernias repaired using these techniques.
Secondary Objectives:
- Determine surgical complications and associated morbidity and mortality
- Assess pain and quality of life
- Investigate reoperation rates
- Describe risk factors for hernia formation
- Define the usefulness of prehabilitation programs
STUDY DESIGN
Prospective observational dynamic cohort.
DISEASE UNDER STUDY
Primary and incisional ventral hernias.
POPULATION
Approximately 80 patients per year.
TIMELINE
Start: March 2026

Total duration: 10 years
INTRODUCTION AND JUSTIFICATION
Ventral and incisional hernias are among the most frequent conditions in general surgery and
represent a major public health problem due to their high prevalence, recurrence rates, and impact
on quality of life.
Minimally invasive techniques (laparoscopic and robotic) have significantly changed surgical
management, showing advantages such as fewer complications, less pain, and shorter hospital
stays.
However, they also have limitations, including higher costs, longer operative times, and a significant
learning curve.
This study aims to evaluate recurrence, pain, quality of life, complications, and long-term outcomes.
HYPOTHESIS
This is a descriptive study aiming to estimate 5-year recurrence with ±4% precision.
PRIMARY OBJECTIVE
Evaluate recurrence rate after minimally invasive abdominal wall surgery.
SECONDARY OBJECTIVES
- Surgical complications and morbidity/mortality
- Pain and quality of life
- Reoperation rates
- Risk factors
- Role of prehabilitation
STUDY DESIGN
Prospective observational cohort.
SUBJECT SELECTION
Adult patients undergoing minimally invasive surgery.
INCLUSION CRITERIA
Patients indicated for minimally invasive abdominal hernia repair.
EXCLUSION CRITERIA

- Age <18
- Refusal to participate
- Only inguinal hernias
- Not candidates for minimally invasive surgery
SAMPLE SIZE
Approximately 400 patients over 5 years.
STUDY DEVELOPMENT
Includes preoperative, 3-month, 12-month, and long-term follow-up visits.
VARIABLES
Demographics, clinical history, surgical details, complications, and outcomes.
RESULT EVALUATION
Primary analysis includes recurrence rate and Kaplan-Meier curves.
Secondary analysis includes complications, pain, quality of life, and reintervention.
LIMITATIONS
No external control group.
ADVERSE EVENTS
Observational study with no additional interventions.
ETHICS
Conducted according to the Declaration of Helsinki and data protection laws.
CONFIDENTIALITY
All personal data anonymized and coded.
INSURANCE
No insurance required due to observational nature.
ECONOMIC REPORT
No funding or compensation.

PRACTICAL CONSIDERATIONS
Data recorded according to Good Clinical Practice.
STATISTICAL ANALYSIS
Descriptive and analytical statistics, including regression and survival analysis.
PUBLICATION
Results will be published in scientific journals.
BIBLIOGRAPHY
(References maintained as in original document)