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CompletedNCT05606029Updated Nov 4, 2022

A Case Series on Incidentally Detected Gallbladder Malignancy

An observational study in Gallbladder Malignant Neoplasm, sponsored by Osmania Medical College. Completed at 1 site in India. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-11-04.

Sponsored by Osmania Medical College · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
180
Ages
18 Years to 70 Years
Sex
All
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Study summary

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).

Read the 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).

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Conditions studied

  • Gallbladder Malignant Neoplasm

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Keywords

  • Gallbladder,
  • Polyp
  • Gallstones
  • Malignancy
  • Perforation
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In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 180 is below the median of 204 across 1,683 observational studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

This is the only study on the registry with Osmania Medical College as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Eligibility criteria

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

Exclusion Criteria: All those who already diagnosed with gallbladder malignancy

-

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Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
180 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • ProcedureCholecystectomy, extended cholecystectomy

    Cholecystectomy and histopathological evaluation

    Also known as: Histopathological evaluation of the specimen

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What researchers measure

Primary outcomes

  1. Diagnosed with Gallbladder malignancy

    Those who underwent cholecystectomy for benign conditions are diagnosed with gallbladder malignancy

    Time frame: For one year

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Study locations

1 site
  • Osmania General Hospital
    Hyderabad, Telangana 500012, India
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Aug 8, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05606029
Lead sponsor
Osmania Medical College
Responsible party
Dr. Sathaiah Dadi (MS General Surgery, Principal investigator, Osmania Medical College) — Principal investigator
First posted
Nov 4, 2022
Start date
Jan 1, 2019
Primary completion
Dec 31, 2019
Completion
Dec 31, 2019
Last update
Nov 4, 2022

Study contacts

Sathaiah Dadi, MS Gen Surg
principal investigator · Osmania Medical College

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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