Colonoscope with a sub-distal hyper-flaccid segment for improved insertion at colonoscopy: a randomized study.

Area of Science:

• Gastroenterology
• Medical Device Engineering
• Clinical Endoscopy

Background:

• Colonoscopy involves navigating sharp colonic flexures, where axial pushing forces can cause endoscope impaction.
• This impaction can lead to patient discomfort and hinder procedural progression.

Purpose of the Study:

• To evaluate colonoscopes with a novel hyper-flaccid segment designed to improve navigation in sharp bends.
• To assess the impact of this design on patient-reported pain during colonoscopy.

Main Methods:

• A single-blinded randomized study compared two prototype colonoscopes with varying flaccid segments to a standard colonoscope.
• 400 patients were randomized, with patient pain evaluation as the primary endpoint.

Main Results:

• Severe pain was reported by 7% of patients using the prototype colonoscopes versus 18% with the standard scope (p = 0.001).
• A trend towards shorter cecal intubation times was observed with the prototype (14.1 min vs. 15.5 min).
• Cecal intubation rates were similar between prototype (89%) and standard (85%) groups.

Conclusions:

• Colonoscopes incorporating a hyper-flaccid segment effectively reduce patient pain.
• This design facilitates negotiation of sharp bends without compromising intubation success or efficiency.