Title: "Evaluation Of Short-Term (30 Days) Surgical Outcomes Of Laparoscopic Anti-Reflux Surgery : A Multicentre Prospective Observational Cohort Study In India"

Chief Investigator: Dr Ramesh Makam (AV Hospital and Arka Anugraha Hospital)

Co- Investigators: Dr. Ramesh Agarwalla

Dr. Kamal Mahawar

Dr. Tulip Chamany

Dr. Gaurang Ramesh

Dr. Sahana Manjunath

Dr. Nikhil .M

Dr. Shaik Mohammed Safiuddin

BACKGROUND:

Hiatal hernias are herniation of the stomach or other abdominal organs into the chest through the oesophageal hiatus in the diaphragm. Hiatal hernias have been associated with gastroesophageal reflux disease (GERD). The typical presentation leading to an evaluation for a hiatal hernia is gastroesophageal reflux disease (GERD). Patients typically complain of heartburn and sometimes regurgitation. While heartburn is the most common complaint, some patients will present with extra-esophageal symptoms such as a chronic cough or asthma. The presentation of regurgitation or extra-esophageal symptoms typically is a sign of disease progression. The prevalence and size of the hiatal hernia has been described to correlate with the severity of reflux. The presence of a hiatal hernia has also been identified in nearly 40% of obese patients. Some of the causes of hiatal hernias have been attributed to age, stress, and degenerative processes on the diaphragm.

There are traditionally four types of hiatal hernias:

·      TYPE I (SLIDING TYPE): Defined as a migration of the GEJ into the chest secondary to an attenuated phrenoesophageal ligament. This is the most common type of hiatal hernia.

·      TYPE II: True paraesophageal hernias (PEH), occur when the gastric fundus herniates anterior to the oesophagus while the GEJ remains in the abdomen.

·      TYPE III: Hiatal hernias are a combination of types I and II, in which both the GEJ and the gastric fundus herniate into the chest.

·      TYPE IV: Hiatal hernias occur when not only the stomach, but other abdominal organs such as the colon, also herniates into the chest through the oesophageal hiatus

The term giant paraesophageal hernia refers to large hiatal hernias where at least 50% of the stomach is in the mediastinum or the hernia measures at least 6 cm on endoscopy.

The actual prevalence of paraesophageal hernias is not known. The most common hiatal hernia is type I, which accounts for up to 95% of all hiatal hernias. Paraesophageal hernias may account for up to 14% of all hiatal hernias, and the majority of paraesophageal hernias are of the type III variety. These hernias can be associated with life-threatening complications such as gastric volvulus leading to necrosis or perforation of the stomach.

NEED FOR STUDY:

The accepted surgical approaches to hiatus hernia repair include thoracotomy, laparotomy and, more recently, laparoscopy. While each approach has its particular advantages, there have, as yet, been no randomized controlled trials to demonstrate superiority of one technique over the others. Consequently, the choice of the approach still largely depends on individual surgeon preference and skills. Laparoscopic hiatus hernia repair has gained prominence as the surgical technique of choice due to its advantages, such as reduced postoperative pain, shorter hospital stay, and quicker return to normal activities when compared to open surgical methods.

Despite these benefits, there is a notable lack of multicentre, evidence-based research focused on the short-term surgical outcomes of laparoscopic hiatus hernia repair in India. Existing studies are often single-centre investigations with limited sample sizes, which restrict their generalizability. Moreover, India’s diverse population, varying in age, gender, and socioeconomic status, coupled with disparities in healthcare access and surgical expertise across different regions, necessitates a multicentre approach to obtain a more comprehensive understanding. This study aims to fill this critical gap in the literature by evaluating the short-term surgical outcomes of laparoscopic hiatus hernia repair across multiple healthcare centres in India, thereby contributing to the optimization of surgical protocols and improvement of patient care in this specific context.

GOAL OF THE STUDY:

The study aims to assess 30-day morbidity rates of anti-reflux surgery in India according to the Clavien-Dindo Grade (Annexure-1), identify potential risk factors and confounding variables related to patient demographics and comorbidities, and document operative details.

By doing so, the study seeks to provide a comprehensive, evidence-based framework that can guide clinical decision-making and policy formulation for the management of hiatus hernia in India.

OBJECTIVES:

1. The primary objective is to evaluate 30-day morbidity and mortality of anti-reflux surgery in India.

2. To identify potential risk factors associated with 30-day morbidity and mortality.

3. To assess the incidence and types of different postoperative complications.

4. To analyse the length of hospital stay and its influencing factors.

5. To evaluate patient related, disease related, surgeon related factors responsible for 30 days morbidity and mortality. 

MATERIALS AND METHODS:

SOURCE OF DATA:

All adult patients undergoing elective Laparoscopic Anti-Reflux Surgery in India between _______ and __________. (6 months from the time of approval of the study)

METHODS OF COLLECTION OF DATA:

A. Study design: Multicentre prospective observational cohort study.

B. Study period: 6 months

C. Place of study: Hospitals all over India

D. Inclusion Criteria:

1. Age 18 years or older.

2. Patients undergoing elective Anti-Reflux Surgery.

3. Both primary and recurrent/ complex hiatus hernia without complications. 

4. Willingness to participate, as evidenced by signed informed consent.

E. Exclusion Criteria:

1. Patient not willing to give informed consent

2. Revisional Anti-Reflux Surgery.

3. Emergency Hiatal Hernia Surgery.

4. Incidental Hiatal Surgery (for example crural repair with bariatric surgery)

5. Pregnancy

6. Untreated Oesophageal Motility Disorders

7. Patients with severe medical conditions and multiple comorbidities.

F. Methodology:

After obtaining approval and clearance from the institutional ethics committee, the patients fulfilling the inclusion criteria will be enrolled for the study after obtaining informed consent.

This study is an initiative for research by Indian Association of Gastro Intestinal Endoscopic Surgeons (IAGES). The study adopts a multicentre prospective observational cohort design, open to participation from any accredited laparoscopic surgery centre in India. This open participation model aims to capture a wide range of surgical practices, healthcare settings, and patient demographics, thereby enhancing the study’s generalizability.

Google forms regarding surgeons’ personal details are sent to all members and non-members across the country. These forms will be filled by those interested to participate in the study. Excel database sheet will then be sent to these interested surgeons. Data collected till 6 months will be assessed and all factors will be studied for statistical significance.

Patient Recruitment:

Centres will recruit patients based on the predefined inclusion and exclusion criteria. Each participating centre will designate a study coordinator responsible for patient recruitment, informed consent, and data collection.

Data Collection:

Standardized electronic data collection forms (either in MS Excel file or Google Forms) will be employed to ensure uniformity in the data gathered. These forms will capture information on patient demographics, comorbidities, operative details, and postoperative complications. Data will be collected at multiple time points: preoperatively, intraoperatively, and postoperatively up to the 30-day follow-up.

Data Management:

A centralized database will be established to collate and manage data from all participating centres. Data will be anonymized to maintain patient confidentiality.

Statistical Analysis:

Data will be analysed using robust statistical methods suitable for observational data, including descriptive and inferential statistics. Subgroup analyses will be conducted based on patient demographics, comorbidities, and operative details to identify potential risk factors and confounding variables.

A statistician has been appointed by Indian association of gastrointestinal surgeons for analysis of data. We set significance at p<0.05. A multivariate analysis will be done to understand which factors are associated with and/or predict higher morbidity and mortality.

The article will be written and sent for publication by the end of 6 months.

Primary End Point: The primary end point of this study is to evaluate the 30-day morbidity following laparoscopic hiatus hernia repair, as assessed by the Clavien-Dindo Grade. This grading system is a standardized method for classifying surgical complications and provides a comprehensive framework for evaluating the severity and impact of postoperative complications. The 30-day timeframe is chosen to focus on short-term outcomes, which are critical for assessing the immediate success and safety of the surgical procedure. The Clavien-Dindo Grade will be used to categorize complications into different grades, ranging from Grade I (minor complications requiring no treatment) to Grade V (death).

Secondary End Point: Duration of procedure, length of stay, procedure specific complication rates such as bleeding, bowel injury, pneumothorax, solid organ injury and reoperation rates

We will examine a range of patient specific, surgeon specific, and facility specific variables to see if they impact total complication rates or severe complication rates.

Patient factors like Age, Sex, Body Mass Index, associated comorbidities.

Surgeon factors: The correlation between the surgeon’s experience level (measured in years of practice and number of similar procedures performed) and postoperative complications will be analysed.

Facility related could be private/academic; rural/urban; small set up (< 50 beds) /big set up (>50 beds) etc. 

Benefits of this study:

This will be the first multicentre Indian study on 30 days morbidity and mortality in Laparoscopic Hiatus hernia repair. It will not only help us to analyse our own data but will encourage surgeons to maintain data of their patients.

Evidence-Based Practice: By rigorously evaluating short-term surgical outcomes, the study will provide valuable evidence that can guide clinical decision-making and treatment protocols.

Enhanced Generalizability: The multicentre design, open to any accredited laparoscopic surgery centre in India, ensures a diverse and representative sample, thereby enhancing the generalizability of the findings.

Risk Factor Identification: The study will help identify potential risk factors and confounding variables, such as patient demographics and comorbidities, which can be crucial for preoperative planning and patient counselling.

Quality Improvement: The data collected will serve as a benchmark for quality improvement initiatives in surgical centres across India. It will help identify areas where intervention is needed to improve patient outcomes.

Conflict of Interest: None

Financial Grants: The funding for statistical analysis will be taken care by IAGES.                                             

  ANNEXURE- 1

Clavien-Dindo classification of surgical complications