Our retrospective comparative study has found that CCE was reported by patients to be a more comfortable procedure (9.2 vs 6.7, p<0.0001) with comparable satisfaction scores compared to colonoscopy (8.3 vs 7.7, p=0.28). A majority of our patients (77.5%, n=31/40) also preferred to have a CCE compared to colonoscopy if a repeat endoscopic procedure is required in the future. Among these, a further 77.4% (24/31) of patients still preferred a CCE over colonoscopy even if the results of the CCE would require them to have a colonoscopy for any intervention or further diagnostic work-up.
The strength of this study is that to our knowledge, it is the only study that purely focuses on patient reported outcomes following both CCE and colonoscopy procedures in a symptomatic cohort. In a mix of screening and symptomatic patients, Ojidu et al reported in different group of patients undergoing either CCE, colonoscopy and CT colonoscopy (CTC) mean GCS’s of 1.3, 3.32, and 1.96 respectively (20). Furthermore, when comparing CCE and CTC, they also found that 76.8% reported no discomfort for CCE compared to 31.9% for CTC (20). In a CRC screening cohort, Thygesen et al reported moderate to high discomfort in 89% participants undergoing colonoscopy compared with7% undergoing CCE (21). It is interesting to note that despite receiving intravenous procedural sedation and analgesia for colonoscopy patient reported comfort scores are poorer, reflecting the invasive nature of this procedure.
We did not report on any patient diagnosis in this study and purely focused on patient reported procedural outcomes of comfort and satisfaction. The impact of diagnosis on the overall satisfaction and perceived comfort is not known. However, it should not significantly affect the results as patients were unselected and average risk and there were no cases of cancer detected.
An advantage is that all our participants were in a comparative study and underwent both tests giving subjects the opportunity to compare both procedures directly. This could however be considered not to reflect their preferences in actual clinical practice. In particular, the need for a therapeutic colonoscopy after a positive CCE could be a disadvantage. In our cohort though, the majority who reported a preference for CCE in the future, did so accepting of that possibility. In addition, this argument supposes there is never a need for a repeat colonoscopy, for preparation quality, anticoagulant or completion issues. As such the opportunity to directly compare tests remains a valid assessment.
Both procedures resulted in similar satisfaction scores (CCE - 8.3 vs colonoscopy - 7.7, p=0.28). For CCE, high satisfaction score could be related to the minimally invasive nature of the procedure, the fact that no/minimal discomfort or pain is involved, and the lack of embarrassment associated with colonoscopy. Furthermore, in our centre, CCEs are performed in our dedicated Capsule Endoscopy Department by trained nursing staff, medical staff, and technicians as outpatient procedures. As patients are not given any sedative medications for CCE, they can go about their day as normal, with some patients opting to return to work while others seek the comfort of their own homes. For colonoscopy, the high satisfaction score could be related to the professionalism of the endoscopy department staffs, the definitive nature of colonoscopy in most cases, and the ability to perform intervention on same procedure. The absence of complications in our cohort also could be associated with high satisfaction scores.
Of note for both procedures, patients are usually contacted prior to attending the procedure to ensure compliance with bowel preparation and diet, and to address any concerns that they may have, which could have contributed to similarly high overall satisfaction.
Despite having higher comfort and satisfaction scores, the amount of bowel preparation and booster medications (Table 3) that needed to be taken was identified as the main issue causing dissatisfaction with CCE (25% of patients). CCE relies on a high degree of bowel cleansing as it lacks the air insufflation and the ability to perform colonic cleaning and suctioning in colonoscopy. Apart from that, unlike for a Small Bowel Capsule (SBCE), booster medications are needed to propel the capsule through a patient’s small bowel and colon to ensure a complete examination. This regimen, although appearing excessive, is based on the 2012 ESGE guidelines for CCE (9). Since the completion of this study, CCE preparation in our unit has been changed to a lower volume split dose MoviPrep (Norgine, Middlesex, UK) preparation pre-CCE, with MoviPrep and Castor oil as boosters. Audits of these changes has shown an 87% capsule excretion rate and also improved image quality (22, 23). We have yet to assess patient’s satisfaction and comfort following this change but due to reduction of the volume of bowel preparation, one would assume higher scores will be awarded.
This study also highlights the disconnect between the level of comfort patients experienced compared to endoscopy reported Modified-Gloucester-Comfort-Scores. The GCS, although not formally validated, is used to assess patient comfort during colonoscopy in all Irish endoscopy units, forms part of quality indicators of colonoscopy and is regularly audited by NQAIS (24-26). Similar discordances have also been reported in other studies (20, 27). The GCS was designed to be provided by the endoscopy nurses and agreed by the endoscopist, but it is possible that they are too intimately involved in the procedure to provide a truly objective assessment (20). Poor comfort outcomes may cause patients to refrain from engaging with similar diagnostic tools in the future. Development and implementation of comfort scores that includes patient’s perspective such as the Patient-Reported Scale for Tolerability of Endoscopic Procedures (PRO-STEP) (28) or scores that have shown correlation with patient reported outcomes such as the St. Paul's endoscopy comfort score (SPECS) (24) should be considered. Although these scores are validated their use are not yet common. GCS itself has never been validated for patient use. To date, there isn’t a validated scoring system that measures both patients reported satisfaction and comfort. This is why we chose the simpler 10-point Likert scale in our interview for better patient comprehension and understanding.
In terms of factors that may be associated with comfort scores, Ball et al has reported that the amount of sedation given to a patient during colonoscopy does not correlate with comfort scores (ρ<0.2) (29). It has been previously reported that symptomatic patients often experience poorer comfort scores than screening patients (20), whether or not this played a role in our cohort is difficult to determine. The use of CO2 insufflation has been associated with better comfort scores (30), but we did not use CO2 in our colonoscopies during this study period due to unavailability. Since study completion, all endoscopy rooms in our department has been installed with a CO2 insufflation device. The correlation of its use and comfort score in our centre has yet to be reviewed. Both of our endoscopists performing the colonoscopies met and exceeded minimum NQAIS standards. The use of the scope guide has not been found to be beneficial in improving patients comfort scores in experienced endoscopists and is unlikely to have affected our results (31).
In our cohort, we did not find a difference between patients reported satisfaction and comfort when looking at age (less than and above 50) and gender as possible variables. We did not have available data to assess patients’ anxiety levels pre-procedure, duration of colonoscopy, patients BMI and endoscopist reported ease of colonoscopy, all of which may be possible factors that may result in a more difficult and uncomfortable procedure (5). This does open possibility for future prospective research.
As mentioned previously, 77.5% (31/40) of patients would prefer to have CCE over colonoscopy in the future. Interestingly of these 31 patients, 77.4% (24/31) would still choose to have CCE as first line even with the knowledge that they may have to have a colonoscopy as a second procedure if further investigation or intervention was required. As explained in the introduction, CCE has proven efficacy in a variety of clinical situations and can be used in both the symptomatic and screening cohort (11-19). As such, we would like to recommend Clinicians include alternatives to colonoscopy such as CCE when discussing available investigations with patients. Providing proven alternatives, especially ones that are associated with greater levels of comfort and less complications should form part of the process of informed consent.