Clinical trial NCT05228353: Clinical Audit of GI Endoscopic Complications in a Tertiary Care Hospital
Official title: Clinical Audit of GI Endoscopic Complications in a Tertiary Care Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endoscopy
Complication
Keywords: endoscopy
complication
Lead sponsor: Asian Institute of Gastroenterology, India
Sponsor class: OTHER
First posted: 2022-02-08
Enrollment: 42471
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical audit of GI Endoscopic complications in a Tertiary Care Hospital
timeFrame: 6 months
Secondary outcomes:
measure: Risk factors for endoscopy complications
timeFrame: 6 months
measure: Morbidity associated with endoscopic complications
timeFrame: 6 months
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: AIG Hospitals
state: Telangana
Study officials:
affiliation: Consultant
name: Inavolu Pradev, MBBS, MD, DM
role: PRINCIPAL_INVESTIGATOR
affiliation: Consultant
name: Hardik Rughwani, MBBS, MD, DM
role: PRINCIPAL_INVESTIGATOR
affiliation: Consultant
name: Mohan ramchandani, MBBS, MD, DM
role: STUDY_DIRECTOR
affiliation: Chief
name: Nageshwar D Reddy, MBBS, MD, DM
role: STUDY_CHAIR
affiliation: Consultant
name: Anudeep KV, MBBS, MD, DM
role: PRINCIPAL_INVESTIGATOR
References:
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