Small Bowel Capsule Endoscopy: Experience From a Single Large Tertiary Care Centre
Condition: Small Bowel Disease; Small Bowel Ulcers; Capsule Endoscopy; Small Bowel Tumor
Study type: Observational

Summary: 
      Examination of the small bowel has been considered a challenge for several anatomical (i.e.
      distance from external orifices, length) and physiological (i.e. active peristalsis) reasons.
      Conventional techniques of endoscopy are limited by length while radiologic examinations,
      such as barium studies, are insensitive for evaluating small bowel pathology. An ingestible
      miniature camera device capable of obtaining images of the whole small intestine was
      developed due to a need for the exploration of this "final frontier". The purpose of this
      article is to review and share our institution's results using small bowel capsule endoscopy,
      with special reference to the existing literature.
    

Detailed description: 
      1. INTRODUCTION

           Examination of the small bowel (SB) has been considered a challenge for several
           anatomical (i.e. distance from external orifices, length) and physiological (i.e. active
           peristalsis) reasons. Conventional techniques of endoscopy are limited by length while
           radiologic examinations, such as barium studies, are insensitive for the evaluation of
           pathology in the SB. An ingestible miniature camera device capable of obtaining images
           of the whole small intestine was developed due to a need for the exploration of this
           "final frontier". Video capsule endoscopy (CE) is a breakthrough in medical history for
           noninvasive imaging of the entire small intestine. It was first introduced in 2000, and
           since then more than 700 studies have been published, which is indicative of its ease
           and the widespread acceptance of this new diagnostic tool. A wide range of uses for CE
           has been reported in the literature, but the majority of the studies have aimed to
           evaluate the cause of obscure gastrointestinal bleeding (OGIB).

        2. RATIONALE The purpose of this article is to review and share our institution's
           experience using small bowel CE, with special reference to the existing literature. Most
           published reports on capsule endoscopy are limited to small group of patients.

        3. STUDY OBJECTIVES 3A. Primary Objective- To study the indications and diagnostic yield of
           capsule endoscopy.

      3B. Secondary Objective- To study the gastric emptying time, small bowel transit time and
      findings visualized with capsule endoscopy.

      4. STUDY POPULATION This observational retrospective study will be conducted in AIG
      Hospitals, Hyderabad. All patients who underwent capsule endoscopy till 30 June, 2021 will be
      enrolled in the study.

      5. DESIGN AND DURATION OF THE STUDY- It will be a retrospective observational study.

      6. METHODOLOGY

      6a. SUBJECT RECRUITMENT - All patients who underwent capsule endoscopy in our hospital till
      30 June, 2021 will be enrolled in the study.

      6b. RANDOMIZATION AND BLINDING- N/A

      6c. STUDY METHODS- This observational study will be conducted after obtaining ethical
      clearance from institutional human ethical committee. All patients who underwent capsule
      endoscopy till date will be enrolled in the study.

      6d. STUDY PROCEDURE- The data will be entered in Microsoft excel sheet and analysed ' 6e.
      METHODS OF ASSESSMENT- The following variables will be noted. A. Age of the patient B.
      Indications of the procedure C. Pre-Existing illness D. Gastric Emptying time E. Small Bowel
      transit time F. Capsule Retention G. Findings visualized on capsule endoscopy study

      6e. STOPPING OR DISCONTINUATION CRITERIA- N/A

      7. SAMPLE SIZE CALCULATION- The sample size will include all patients who underwent capsule
      endosocopy till 30th June 2021 in AIG hospitals Hyderabad.

      8. STATISTICAL ANALYSIS- Data will be expressed as median and percentile values (5th, 25th,
      75th and 95th percentiles). The upper limit of normal will be defined as the 95th percentile
      of expected values. P≤0.05 will be considered statistically significant.

      9. ETHICAL JUSTIFICATION OF THE STUDY Small Bowel Capsule endoscopy is a safe and effective
      procedure for diagnosis of small bowel disorders. It is especially helpful in finding the
      cause for obscure gastro-intestinal bleed. There is lack of large studies on diagnostic yield
      and other visualized findings. This study aims to share our institution's results using small
      bowel CE, with special reference to the existing literature.
    

Intervention name(s): Small Bowel Capsule Endosocopy
Intervention type(s): Procedure
Intervention description(s): A wireless capsule is ingested by the patient. It moves passively along with the peristaltic movements to capture images of the small intestine. The images are processed and recorded by data recorder worn on a belt. The recorded images are downloaded and analyzed by the computer software.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The study includes patients who underwent capsule endoscopy from Jan 2013 till 30 June,
        2021.
      
Keywords: capsule endoscopy; small bowel