Clinical Audit of GI Endoscopic Complications in a Tertiary Care Hospital

September 13, 2023 updated by: Asian Institute of Gastroenterology, India
Endoscopy of the upper gastrointestinal tract using fiberoptic endoscopes was introduced in the late 1950s and provided the first opportunity for direct visualization of the esophagus, stomach, and duodenum and colon in vivo. GI Endoscopy is usually considered a safe and effective procedure. However complications do exist and procedure related costs are significant. There is a lack of prospective studies on complications of diagnostic and therapeutic endoscopic procedures.There is a lack of prospective studies on complications of diagnostic and therapeutic endoscopic procedures. Knowledge of potential endoscopic adverse events, their expected frequency, and the risk factors for their occurrence may help to minimize the incidence of adverse events. Review of adverse events as part of a continuing quality improvement process may serve to educate endoscopists, help to reduce the risk of future adverse events, and improve the overall quality of endoscopy.

Study Overview

Status

Completed

Conditions

Detailed Description

1. STUDY OBJECTIVES

1a. Primary objective - Clinical audit of complications in gastrointestinal endoscopy unit from a tertiary care centre.

1b. Secondary objective - NA

2. STUDY POPULATION- Consecutive patients coming to the hospital for any gastrointestinal endoscopic procedure for 6 months duration and develops a complication.

3. DESIGN AND DURATION OF THE STUDY- It will be an observational prospective audit of all consecutive patients coming to the hospital for any gastrointestinal endoscopic procedure for 6 months duration.

4. METHODOLOGY

4a. SUBJECT RECRUITMENT - All patients who undergo any diagnostic or therapeutic endoscopic procedure during the period and develop any complication.

4b. RANDOMIZATION AND BLINDING- N/A

4c. STUDY METHODS- This observational study will be conducted after obtaining ethical clearance from institutional human ethical committee. All patients who undergo any endoscopic procedure during the period including upper gastrointestinal endoscopy, colonoscopy, endoscopic retrograde cholangiopancreatography (ERCP), Endoscopic Ultrasound (EUS), Peroral Endoscopic Myotomy (POEM), Enteroscopy, Endoscopic mucosal resection (EMR), Endoscopic Submucosal Resection (ESD), Submucosal Tunnel Endoscopic Resection (STER), Anti Reflux Mucosal resection (ARMS), Anti Reflux Mucosal ablation (ARMA), GERD-X, Endoscopic Sleeve Gastrectomy (ESG) and develops an complication will be enrolled in the study.

4d. STUDY PROCEDURE- For each patient who develops a complication , Following variables will be collected: Details of procedure, Indication of procedure, H/O Antiplatelets, anticoagulants, Any co-morbidity, Operator Characteristics, Time of procedure, Duration of procedure, Type of sedation, Time of detection of complication, Length of hospital stay/ICU stay, Mortality, Financial Cost, 30 days Follow-up, Re-admission rate, American Society of Anaesthesiologists (ASA) physical status classification, Relevant Images of the procedure, Relevant Videos of the procedure.

4e. METHODS OF ASSESSMENT- As per clinical protocol, each patient will be assessed by the primary investigator at 24 hours after their procedure to assess for possible symptoms and complications and to answer any questions. Further, for the purposes of this study, all patients will be contacted by telephone 30 days or more after their procedure. A standardized telephone interview and a review of the electronic medical record will be used to obtain follow-up data. Following complications will be recorded as per ASGE guidelines.

  1. Perforation
  2. Bleeding
  3. Infection
  4. Pancreatitis
  5. Cardio-pulmonary adverse event
  6. Pain/ discomfort
  7. Gas explosion
  8. Thromboembolism
  9. Instrumental penetration/ impaction
  10. Drug reaction

  11. Mortality

    4f.STOPPING OR DISCONTINUATION CRITERIA- N/A

    5. SAMPLE SIZE CALCULATION- Since this is a clinical audit, all the patients coming for GI endoscopic procedures and developing complications will be recorded.

    6. STATISTICAL ANALYSIS- Statistical analysis including both univariate and multivariate analysis, when appropriate, on available data. Univariate analysis will be conducted using chi-square test, Fisher's exact test, and relative risks with their 95% confidence intervals. Multivariate analysis of the main predictors of complications will be performed using a forward stepwise logistic regression model with the SAS statistical system. All candidate independent variables, age included, will be analyzed in a dichotomous manner.

    7. ETHICAL JUSTIFICATION OF THE STUDY- GI Endoscopy is a safe and effective procedure. However complications do exist and procedure related costs are significant. There is a lack of prospective studies on complications of diagnostic and therapeutic endoscopic procedures. This study aims to quantify and identify risk factors associated with endoscopy procedure complications. Knowledge of potential endoscopic adverse events, their expected frequency, and the risk factors for their occurrence may help to minimize the incidence of adverse events. Review of adverse events as part of a continuing quality improvement process may serve to educate endoscopists, help to reduce the risk of future adverse events, and improve the overall quality of endoscopy.

Study Type

Observational

Enrollment (Actual)

42471

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Telangana
      • Hyderabad, Telangana, India, 500032
        • AIG Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients who undergo any diagnostic or therapeutic endoscopic procedure during the period and develop any complication will be enrolled in the study.

Description

Inclusion Criteria:

  • All patients who undergo any diagnostic or therapeutic endoscopic procedure during the period and develop any complication including:

    • Diagnostic and therapeutic upper gastrointestinal endoscopy,
    • Diagnostic and therapeutic colonoscopy,
    • Endoscopic retrograde cholangiopancreatography (ERCP),
    • Endoscopic Ultrasound (EUS),
    • Peroral Endoscopic Myotomy (POEM),
    • Enteroscopy (Antegrade, Retrograde or spiral)
    • Endoscopic mucosal resection (EMR),
    • Endoscopic Submucosal Resection (ESD),
    • Submucosal Tunnel Endoscopic Resection (STER)
    • Anti- Reflex Mucosal Ablation (ARMA)
    • Anti- Reflex Mucosal Resection (ARMS)
    • GERD-X
    • Endoscopic Sleeve Gastrectomy (ESG)
    • Intra-gastric Balloon insertion

Exclusion Criteria:

  • Those who are not willing to give the consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical audit of GI Endoscopic complications in a Tertiary Care Hospital
Time Frame: 6 months
The study aims to do audit of all endoscopic procedures occurring over six months duration and record any complications occurring during that period. Information related to the complications will be recorded.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk factors for endoscopy complications
Time Frame: 6 months
The information will be recorded to find risk factors for procedures so that future complication rate can be reduced. Besides this will help us in comparing the mortality and morbidity rate as compared with what is described in literature.
6 months
Morbidity associated with endoscopic complications
Time Frame: 6 months
The study aims to review the morbidity associated with endoscopic complications during the study period.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asian Institute of Gastroenterology, India

Investigators

  • Principal Investigator: Inavolu Pradev, MBBS, MD, DM, Consultant
  • Principal Investigator: Hardik Rughwani, MBBS, MD, DM, Consultant
  • Study Director: Mohan ramchandani, MBBS, MD, DM, Consultant
  • Study Chair: Nageshwar D Reddy, MBBS, MD, DM, Chief
  • Principal Investigator: Anudeep KV, MBBS, MD, DM, Consultant

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Actual)

January 31, 2022

Study Completion (Actual)

January 31, 2022

Study Registration Dates

First Submitted

January 3, 2022

First Submitted That Met QC Criteria

January 27, 2022

First Posted (Actual)

February 8, 2022

Study Record Updates

Last Update Posted (Actual)

September 14, 2023

Last Update Submitted That Met QC Criteria

September 13, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AIG/IEC-BH&R 14/05.2021-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to share IPD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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