A Case Series on Incidentally Detected Gallbladder Malignancy

A Case Series On Incidentally Detected Gallbladder Malignancy

A retrospective analysis of data, using the Hospital records of all the patients who underwent cholecystectomy for benign conditions at Osmania General Hospital in a year (2019).

Study Overview

• Status: Completed
• Conditions: Gallbladder Malignant Neoplasm
• Intervention / Treatment: Procedure: Cholecystectomy, extended cholecystectomy

Detailed Description

A retrospective analysis of hospital records of patients who underwent Cholecystectomy in a year duration (2019) for any benign condition, diagnosed and confirmed histopathologically as Gallbladder Malignancy.

There are a total of one hundred and eighty patients who underwent cholecystectomy at our hospital (Osmania General Hospital) in 2019, out of which seven patients' histopathological diagnosis was gall bladder malignancy. We reviewed all the case's history, cross-checked the histopathological slides, and confirmed the diagnosis. To avoid the bias of covid-19 pandemic in surgical practice we confined the patient records to the pre-pandemic period of one-year duration (2019).

A total of 180 patients underwent cholecystectomy for various benign conditions in one year, out of which seven patients confirmed histopathologically with Gallbladder malignancy.

Total no of patients : 180 Diagnosed with malignancy : 7 percentage 3.8%

Among these seven, three patients converted from laparoscopic to open procedure for difficulty with resection, two patients are posted for surgery considering empyema of gall bladder preoperatively, one patient in view of gall bladder perforation, and for two patients preoperative diagnosis was gall bladder polyp.

Converted from Lap to Open: 3 Pre-op GB Polyp : 2 Perforated GB : 1 Empyema GB : 2

Only one patient is 40 years old and others are more than 50 years, and two of them are males.

Total : 7 100% Males : 2 28.5% Females : 5 71.5%

Out of a total of 180 patients who underwent cholecystectomy, 117 are females and 63 are males

Total : 180 Males : 63 Females : 117

Out of 180, the age distribution is as follows

Age. Percentage 20 - 29 0 30 - 39 0 40 - 49 0.005 >50. 99.99

It implies that the malignancy rate increases with an increase in the patient's age more than 50years and also with gender (Females > males).

• Study Type: Observational
• Enrollment (Actual): 180

Contacts and Locations

Study Locations

• India
  • Telangana
    • Hyderabad, Telangana, India, 500012
      • Osmania General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All the patients who underwent cholecystectomy for benign conditions like gall stones, polyps,. Etc,.

Description

Inclusion Criteria: All patients who underwent cholecystectomy for benign conditions -

Exclusion Criteria: All those who already diagnosed with gallbladder malignancy

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients who underwent cholecystectomy for benign conditions; In those who underwent cholecystectomy for benign conditions, the histopathological analysis showed the malignancy.	Procedure: Cholecystectomy, extended cholecystectomy; Cholecystectomy and histopathological evaluation; Other Names: Histopathological evaluation of the specimen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnosed with Gallbladder malignancy	Those who underwent cholecystectomy for benign conditions are diagnosed with gallbladder malignancy	For one year

Collaborators and Investigators

• Sponsor: Osmania Medical College
• Investigators: Principal Investigator: Sathaiah Dadi, MS Gen Surg, Osmania Medical College

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: October 25, 2022
• First Submitted That Met QC Criteria: November 2, 2022
• First Posted (Actual): November 4, 2022

Study Record Updates

• Last Update Posted (Actual): November 4, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Malignancy; Perforation; Polyp; Gallstones; Gallbladder,
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: SOUMY2345

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No