Comparisons of Endo-Wing-assisted Colonoscopy Versus Standard Colonoscopy in Improving Adenoma Detection Rate in Symptomatic Patients Suspected of Colorectal Cancer

This study is a single-centre, non-blinded, randomised control trial done at the Hospital Canselor Tuanku Muhriz (HCTM), UKM. All HCTM patients undergoing screening, diagnostic, surveillance and therapeutic colonoscopy at the HCTM endoscopic suite will be included. The exclusion criteria are patients with colonic strictures, active colitis, known polyposis syndrome, known severe diverticulosis, known right hemicolectomy, patients with colostomy/ileostomy and poor bowel preparation. The study will be performed by 3rd and 4th-year surgical registrars who have completed their compulsory endoscopic training. The surgical review board and medical ethics committee of the Faculty of Medicine, Universiti Kebangsaan Malaysia (UKM) have reviewed and given their approval for this study to be conducted. All patients in this study have signed an informed and written consent.

Patients who arrive at the HCTM endoscopy suite will be seen by medical officers and assessed for eligibility. Patients who are eligible and consented to study participation will be randomly allocated using block randomization into either of 2 groups: a standard colonoscopy or Endo-Wing colonoscopy. A standard protocol of 3 litres polyethylene glycol electrolyte solution will be used as bowel preparation at intervals. Conscious sedation will be administered according to standard protocol (IV Midazolam 3mg and IV Pethidine 25mg), and if the endoscopists deem the patient is in discomfort or pain, then an added dose of IV Midazolam 2mg and IV Pethidine 25mg will be given. Bowel preparation quality will be assessed using the Boston Bowel Preparation Scale (BBPS) during colonoscopy.

All colonoscopies will be performed using Olympus Evis Exera III 90 series or Olympus Evis Lucera 260 series colonoscopes. If a patient is randomized to the Endo-Wing™ group, Endo-Wing™ will be attached to the distal tip of the colonoscope. In both groups, the advancement of colonoscopy will be done according to the standard insertion technique. Surgical registrars will be supervised throughout the procedures by a specialist surgeon. Once the caecum is intubated, the minimum time for withdrawal and examination of colonic mucosa is 6 minutes.

Any adenoma/polyps that are seen will be recorded in terms of their presence, location, size and number. Location will classified according to proximal (caecum till transverse colon) and distal (descending colon till rectum) location. The size of the polyps will be divided into categories of 1-5mm, 6-9mm and more than 10mm. On the other hand, the number of adenomas seen will be divided into 1-2, 3-5 and more than 5 adenomas categories.

Patients will be subsequently reviewed in the HCTM endoscopy suite post-colonoscopy for any immediate adverse effects. Once deemed well, patients will be discharged home and followed up with a telephone call 24 hours after the colonoscopic procedure and subsequently one week later.