Nutritional and Metabolic Diseases

Symptoms and General Pathology

All Conditions

Obesity

Hernia

Obesity, Morbid

Overweight

Overnutrition

Nutrition Disorders

Body Weight

Santiago Horgan, MD

The Minimally Invasive Surgery Team (MIST) are establishing a separate research database to find out more about patient's undergoing minimally invasive surgery (laparoscopic , open and robot assisted) procedures at UCSD. The hope is that collection of this information will give physicians a better knowledge and understanding of the benefits of minimally invasive surgery and possibly assist physicians to better manage future patients.

Minimally invasive surgery has become the gold standard in surgical treatment for many indications, such as treatment of gallstones and acute appendicitis. For many other indications, the potential for minimally invasive approaches exist, but the data does not yet exist to establish it as the gold standard. In addition, there are certain patient factors such as age or weight that may influence the success of a minimally invasive procedure.

While there are numerous articles in the literature reporting outcomes for minimally invasive therapies, these series are often notable for small patient populations and varying definitions of treatment success from study to study. Due to the lack of uniformity in reporting patient outcomes, an opportunity exists to establish a standardized database of a large number of patients undergoing these procedures.

A standardized database will facilitate conducting prospective research of the risk factors and benefits of minimally invasive surgery. This analysis will not only enhance the care provided to these patients, it will reduce the use of ineffective therapy, thus promoting improved efficiency while increasing the quality of care provided within the UCSD system.

This is our initial application. Several other departments at UCSD have developed similar databases. There are numerous examples of prospective databases used for similar purposes in the literature. Smithers, et al, used a prospective database of 446 patients undergoing esophagectomy to compare open to laparoscopic outcomes. Nesset, et al, maintained a database of bariatric surgery patients for two decades and was able to draw conclusions from a data set of 1584 patients. Even at smaller numbers, a prospective database is useful. Andrew, et al, described the improvement in outcomes over the learning curve in the first 201 patients undergoing laparoscopic roux-en-Y gastric bypass using such a database. Though labor intensive, Clemmesen, et al, found maintaining a database allowed them to improve care for their patients.

Minimally Invasive Surgery (MIS) Database for the Purpose of Research

Minimally Invasive Surgery (MIS) Database Looking at Patterns of Care, Outcomes, and Prognostic Analysis for the Purpose of Research

Post-operative outcomes including:

30 day morbidity 30 day mortality 30 day readmission Surgical site infection Surgical site occurrences Surgical Reintervention Specific Surgical outcomes (staple line leak, etc)

University of California, San Diego

Professor of Surgery

All patients in the minimally invasive surgery database are patients who have undergone surgical intervention by the Minimally Invasive Surgery faculty. Patients can be further stratified based on the type of procedure that they received. Since this study is primarily creation of a comprehensive database, patient's are not intentionally placed in a certain study arm aside from their procedure type.

Surgical Intervention

Age, Categorical

Age, Continuous

Sex: Female, Male

Dr. Jonathan Li

30 day morbidity

30 day mortality

30 day readmission

surgical site infection

Post Operative Outcomes

Overall Study

Neoplasms

Digestive System Diseases

Appendiceal Neoplasms

Cecal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Cecal Diseases

Intestinal Diseases

Herbal and Botanical

All Drugs and Chemicals

Cola

Group IA will include adult patients operated on for colon tumors who have data on age, sex, data on a previously diagnosed colon tumor, data on incidental appendectomy, and a PHD finding for a removed vermiform appendix.

Group AA will include adult patients who have been operated due to clinical suspicion of acute appendicitis and have data on age, sex, data on the diagnosis of acute appendicitis and accompanying PHD findings of the performed appendectomy.

Surgical removal of the vermiform appendix.

Appendectomy

Ognjen Barcot, MD, PhD

Damir Quien, MD

This study seeks to justify performing an incidental appendectomy according to the following hypotheses:

1. The frequency of neoplasms in pathohistological (PHD) findings of incidental appendectomy (IA) is significantly higher than in PHD findings in appendectomies for acute appendcitis (AA)
2. The number needed to treat (NNT) for appendiceal tumors in the elderly is less than 500.
3. The rate of complicated AA in the elderly population is significantly higher than in the younger age group
4. NNT IA for complicated appendicitis in the elderly is less than 300.
5. NNT IA for potential death due to AA in the elderly is less than 500.

A retrospective cross-sectional study will be done. The archive of all PHD findings will be searched, and then the relevant medical histories at the Clinic of Surgery, University Hospital Center Split in the period from 01.01.2017. to 31.12.2021. The data collection will be done in the period from 01.02.2022. to 31.03.2022. The data collection (extraction) will be done by the main researcher (graduate, Ante Tavra) with at least two other colleagues from the Department of Abdominal-Coloproctological Surgery, University Hospital Center Split (Damir Quien, MD and Dora Bjelanović, MD).

Data will be collected directly from medical history and entered into an overview table. The identity of the respondents will remain secret, and the respondents will be marked exclusively with an identification number. This type of research does not require the informed consent of the patient, and all data collected will be kept in accordance with the provisions of Annex 2 of the Application to Institutional advisory board of UHC Split (approval pending).

Justification of Incidental Appendectomy With Respect to Pathohistological Findings

The data will be available upon reasonable request by the corresponding author (Ognjen Barcot).

Receiver operating curve analysis of the size of the vermiform appendix impacting the classification to neoplastic appendix

Receiver operating curve analysis of the age of the patient impacting the classification to neoplastic appendix

Receiver operating curve analysis of the age of the patient impacting the classification to the complicated appendicitis or death

Incidence of appendiceal neoplasms in IA which will be compared to the incidence of appendiceal neoplasms AA from respective PH samples.

The number of needed incidental appendectomies necessary to avoid one occurence of appendiceal neoplasm

Comparison of incidences of complicated appendicits in young vs elderly

The number of needed incidental appendectomies necessary to avoid one occurence of complicated appendicitis in elderly

The number of needed incidental appendectomies necessary to avoid one death from complicated appendicitis in elderly

University Hospital of Split

Ass. Prof.

Gallbladder Neoplasms

Biliary Tract Neoplasms

Biliary Tract Diseases

Gallbladder Diseases

Patients of all ages who underwent an appendectomy in the elective or non-elective setting.

Patients of all ages who underwent a cholecystectomy in the elective or non-elective setting.

The removed appendix will be evaluated for tumours by the operating surgeon by visual inspection and digital palpation of the specimen. The appendix will not be opened. The surgeon will report his or her findings on a predefined scoring form: he or she will report all abnormalities and writes down whether he or she considers there is an indication for histopathological examination. Subsequently, all specimens will be sent for histopathological examination. Histopathological examination will be conducted according to the local protocol. In case of a neoplasm of the appendix, the treatment strategy is discussed and decided by the local multidisciplinary team. If an additional more extensive resection is decided to be appropriate, the specimens of the re-resection will be evaluated for the presence of remaining tumour tissue.

Inspection and palpation of the appendix

The removed gallbladder will be evaluated for tumours by the operating surgeon by visual inspection and digital palpation of the specimen. The gallbladder is opened in its length, without cutting the cystic duct, and is inspected and palpated. The surgeon will report his or her findings on a predefined scoring form: he or she will report all abnormalities and writes down whether he or she considers there is an indication for histopathological examination. Subsequently, all specimens will be sent for histopathological examination. Histopathological examination will be conducted according to the local protocol. In case of a neoplasm of the gallbladder, the treatment strategy is discussed and decided by the local multidisciplinary team. If an additional more extensive resection is decided to be appropriate, the specimens of the re-resection will be evaluated for the presence of remaining tumour tissue.

Inspection and palpation of the gallbladder

Willem Bemelman, Professor

The FANCY study will investigate whether a selective policy of histopathological examination of appendices and gallbladders based on the intraoperative findings of the surgeon is safe and cost-effective.

Traditionally, all surgically removed appendices and gallbladders are sent to the department of pathology for histopathological examination. This is most likely not necessary in appendices and gallbladders that are not suspicious for a tumour when inspected visually or by palpation. If not detected by visual inspection or palpation, the tumour is usually of early stage and already treated with the resection of the organ. A policy of selective histopathological examination based on the intraoperative findings of the surgeon can probably reduce the amount of appendices and gallbladders that have to be examined by the pathologist, without a risk of undertreatment, with less risk of overtreatment and huge savings annually. In the FANCY study, a nationwide prospective multicenter observational cohort study, all appendices and gallbladders will be evaluated for tumours by visual inspection and palpation by the operating surgeon. The operating surgeon will report his or her findings and also write down whether he or she thinks there is an indication for histopathological examination. Subsequently, all specimens are sent to the pathologist for histopathological examination. Therefore, no aberrant findings will be missed due to this study. The prospective cohort can be compared through modelling to a hypothetical situation where appendices and gallbladders are only examined by the pathologist on indication. The primary outcome is the number of patients per 1000 examined appendices/gallbladders with a neoplasm requiring additional therapy benefitting the patient that would have been unnoticed in the policy of selective histopathological examination.

Selective Rather Than Routine Histopathological Examination Following Appendectomy and Cholecystectomy

Selective Rather Than Routine Histopathological Examination Following Appendectomy and Cholecystectomy; the FANCY Study.

Number of patients per 1000 examined appendices/gallbladders with a neoplasm requiring additional therapy benefitting the patient that would have been unnoticed in the policy of selective histopathological examination.

Costs of the policy with selective and with routine histopathological examination of the appendix/gallbladder.

Incidence of malignancies in resected appendices and gallbladders

Incidence of unnoticed malignancies in resected appendices and gallbladders

Incidence of malignancies in resected appendices and gallbladders that subsequently require more extensive resection or other additional treatment.

Remaining tumour tissue and/or positive lymph nodes in re-resection specimen

Incidence of other aberrant findings as parasite infections, endometriosis, granulomatosis and benign neoplasms.

Incidence of other aberrant findings as parasite infections, endometriosis, granulomatosis and benign neoplasms that require additional therapy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Minimally Invasive Surgery (MIS) Database for the Purpose of Research	NCT00535990	Morbid Obesity Hernia Colorectal Canc... Laparoscopy		18 Years -	University of California, San Diego
Justification of Incidental Appendectomy With Respect to Pathohistological Findings	NCT05202600	Appendix Tumor	Appendectomy	18 Years -	University Hospital of Split
Selective Rather Than Routine Histopathological Examination Following Appendectomy and Cholecystectomy	NCT03510923	Appendix Appendectomy Appendiceal Neo... Gallbladder Cholecystectomy Gallbladder Neo...	Inspection and ... Inspection and ...	-	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Minimally Invasive Surgery (MIS) Database for the Purpose of Research	NCT00535990	Morbid Obesity Hernia Colorectal Canc... Laparoscopy		18 Years -	University of California, San Diego

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