Clinical Audit of GI Endoscopic Complications in a Tertiary Care Hospital

NCT05228353 | Completed DMC

• 1 other identifier: AIG/IEC-BH&R 14/05.2021-03
• Study Type: observational
• Target: 42,471
• Locations: 1 country
• Sites: 1

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.

Conditions

Endoscopy; Complication

Keywords

endoscopy; complication

Outcome Measures

Primary Outcomes (1)

• Clinical audit of GI Endoscopic complications in a Tertiary Care Hospital

  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 Outcomes (2)

• Risk factors for endoscopy complications

  6 months

• Morbidity associated with endoscopic complications

  6 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Those who are not willing to give the consent.

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Study Sites (1)

AIG Hospitals

Hyderabad, Telangana, 500032, India

Location

Related Publications (8)

• Wolfsen HC, Hemminger LL, Achem SR, Loeb DS, Stark ME, Bouras EP, DeVault KR. Complications of endoscopy of the upper gastrointestinal tract: a single-center experience. Mayo Clin Proc. 2004 Oct;79(10):1264-7. doi: 10.4065/79.10.1264.

  PMID: 15473407 RESULT

• Mahnke D, Chen YK, Antillon MR, Brown WR, Mattison R, Shah RJ. A prospective study of complications of endoscopic retrograde cholangiopancreatography and endoscopic ultrasound in an ambulatory endoscopy center. Clin Gastroenterol Hepatol. 2006 Jul;4(7):924-30. doi: 10.1016/j.cgh.2006.04.006. Epub 2006 Jun 22.

  PMID: 16797251 RESULT

• Loperfido S, Angelini G, Benedetti G, Chilovi F, Costan F, De Berardinis F, De Bernardin M, Ederle A, Fina P, Fratton A. Major early complications from diagnostic and therapeutic ERCP: a prospective multicenter study. Gastrointest Endosc. 1998 Jul;48(1):1-10. doi: 10.1016/s0016-5107(98)70121-x.

  PMID: 9684657 RESULT

• Levy I, Gralnek IM. Complications of diagnostic colonoscopy, upper endoscopy, and enteroscopy. Best Pract Res Clin Gastroenterol. 2016 Oct;30(5):705-718. doi: 10.1016/j.bpg.2016.09.005. Epub 2016 Sep 14.

  PMID: 27931631 RESULT

• Richter JM, Kelsey PB, Campbell EJ. Adverse Event and Complication Management in Gastrointestinal Endoscopy. Am J Gastroenterol. 2016 Mar;111(3):348-52. doi: 10.1038/ajg.2015.423. Epub 2016 Jan 12.

  PMID: 26753887 RESULT

• Dumonceau JM, Kapral C, Aabakken L, Papanikolaou IS, Tringali A, Vanbiervliet G, Beyna T, Dinis-Ribeiro M, Hritz I, Mariani A, Paspatis G, Radaelli F, Lakhtakia S, Veitch AM, van Hooft JE. ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2020 Feb;52(2):127-149. doi: 10.1055/a-1075-4080. Epub 2019 Dec 20.

  PMID: 31863440 RESULT

• Cotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, Mergener K, Nemcek A Jr, Petersen BT, Petrini JL, Pike IM, Rabeneck L, Romagnuolo J, Vargo JJ. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010 Mar;71(3):446-54. doi: 10.1016/j.gie.2009.10.027. No abstract available.

  PMID: 20189503 RESULT

• Katrevula A, Singla N, Rughwani H, Jagtap N, Katukuri GR, Godbole S, Teles de Campos S, Memon SF, Inavolu P, Singh AP, Mathur SS, Ashraf A, Patel R, Haja A, Asif S, Katamareddy T, Kalapala R, Ramchandani M, Lakhtakia S, Santosh D, Reddy N. Comprehensive audit of gastrointestinal endoscopy adverse events: Emphasizing quality indicators and economic impact with the AIG-AGREE modification. Endosc Int Open. 2024 Oct 28;12(10):E1242-E1250. doi: 10.1055/a-2435-5445. eCollection 2024 Oct.

  PMID: 39474484 DERIVED

Study Officials

• Inavolu Pradev, MBBS, MD, DM

  Consultant

  PRINCIPAL INVESTIGATOR

• Hardik Rughwani, MBBS, MD, DM

  Consultant

  PRINCIPAL INVESTIGATOR

• Mohan ramchandani, MBBS, MD, DM

  Consultant

  STUDY DIRECTOR

• Nageshwar D Reddy, MBBS, MD, DM

  Chief

  STUDY CHAIR

• Anudeep KV, MBBS, MD, DM

  Consultant

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2022
• First Posted: February 8, 2022
• Study Start: June 1, 2021
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: September 14, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)