Upon discharge from the recovery area, all patients completed a questionnaire regarding their tolerance of the procedure. Patients completed 10-point visual scales indicating pain, choking, gagging, and anxiety both during the insertion of the endoscope and for the remainder of the examination. Patients were asked if they would choose to have the procedure again if endoscopy were indicated in the future. After the procedure, the endoscopist completed a questionnaire assessing the completeness of the examination (eg, whether the endoscope was advanced to the second portion of the duodenum and retroflexion was performed). Indications for the procedure, demographics, clinical findings, complications, the duration of the examination, and recovery duration were noted.
This study was planned to achieve a power of 0.80 to detect changes of 2.0 on tolerance scores between the study groups. Statistical analyses included the independent t-test, Fisher exact test, Mann-Whitney U test, and chi-square test. Multivariate regression analysis and analysis of variance were used to assess the effect that sex may have had on patients’ tolerance scores. Analysis was by intention to treat.
FIGURE 1
Ultrathin endoscope, GIF-N230 (left); standard endoscope, GIF-130 (right)
Results
Of 80 outpatients eligible for the study, 8 (10%) declined entry before randomization. Of 72 remaining, 33 were randomized to ultrathin EGD and 39 to the conventional procedure. The 2 groups were evenly matched for age, race, body mass index (BMI), indication, and EGD findings (Tables 1 and 2). There were more women in the conventional group (80% vs 55%, P = .041; Table 1).
During endoscope insertion, patients undergoing ultrathin EGD had higher mean gagging and choking scores, but lower anxiety scores. For the remainder of the procedure, ultrathin EGD patients had higher gagging scores but no statistically significant differences were noted between groups for pain, choking, or anxiety (Table 2). Twenty-nine patients (88%) assigned to the ultrathin EGD group completed the unsedated examination, and 32 (97%) were willing to repeat an unsedated procedure with the ultrathin endoscope in the future. The mean (± standard error) dose of meperidine was 48.8 ± 2.3 mg; 2 patients required fentanyl 62.5 ± 12.5 mg and midazolam 2.2 ± 0.1 mg. Of the 4 patients allocated to the ultrathin group, which required sedation, the mean dose of meperidine was 50 ± 0 mg and mida-zolam 2.8 ± 0.5 mg. The time required for sedation in the conventional group was 4.1 ± 0.6 min and in the ultrathin EGD group was 5.5 ± 0.5 min (P = .280).
The second portion of the duodenum was reached as often with the ultrathin endoscope as with the conventional apparatus (Table 2). However, retroflexion was achieved less often with ultrathin EGD than with conventional EGD (85% vs 100%, P = .017). Although examination times did not differ between groups, the recovery time was significantly shorter with ultrathin EGD (21.5 ± 2.3 min vs 55.4 ± 2.3 min, P < .0001). No complications were noted in either group. Analysis of variance and multiple regression analysis showed no statistically significant difference in the tolerance scores by sex.
TABLE 1
Patient demographics
Characteristic | Ultrathin EGD (n = 33) | Conventional EGD (n = 39) | P |
---|---|---|---|
Age, y (mean ± SE) | 49.8 ± 2.9 | 46.9 ± 2.2 | .406 |
Female (%) | 55 | 80 | .041 |
Race (%) | |||
Caucasian | 7 | 44 | .123 |
African American | 27 | 39 | |
Other | 6 | 18 | |
Body mass index (mean ± SE) | 28.8 ± 0.88 | 28.7 ± 0.81 | .966 |
EGD, esophagogastroduodenoscopy; SE, standard error. |
TABLE 2
Indications and esophagogastroduodenoscopy findings
Ultrathin EGD | Conventional EGD | P | |
---|---|---|---|
Indications, n (%) | |||
GERD | 26 (79) | 22 (56) | .050 |
Abdominal pain | 9 (27) | 18 (46) | .143 |
Dyspepsia | 2 (6) | 7 (18) | .166 |
EGD findings, n (%) | |||
Esophagitis | 9 (27) | 6 (15) | .254 |
Hiatal hernia | 15 (45) | 13 (33) | .338 |
Gastritis | 20 (61) | 29 (74) | .310 |
Gastric ulcer | 1 (3) | 4 (10) | .366 |
Duodenal ulcer | 0 | 0 | |
CLO test positive | 4 (13) | 11 (28) | .150 |
Patient tolerance, score (mean ±SE) | |||
During insertion | |||
Anxiety | 3.2 ± 0.47 | 5.7 ± 0.45 | <.0001 |
Pain | 2.0 ± 0.34 | 1.4 ± 0.29 | .574 |
Choking | 3.0 ± 0.42 | 1.0 ± 0.32 | .022 |
Gagging | 4.2 ± 0.45 | 1.3 ± 0.34 | <.0001 |
During procedure | |||
Anxiety | 3.1 ± 0.48 | 2.5 ± 0.43 | .350 |
Pain | 1.3 ± 0.31 | 1.2 ± 0.27 | .771 |
Choking | 1.7 ± 0.33 | 1.0 ± 0.25 | .081 |
Gagging | 2.4 ± 0.35 | 1.2 ± 0.28 | .007 |
Technical aspects of procedure | |||
To second portion of duodenum (%) | 97 | 100 | .458 |
Retroflexed (%) | 85 | 100 | .017 |
Duration of examination, min (mean ± SE) | 18.2 ± 0.93 | 17.5 ± 1.1 | .632 |
Duration of recovery, min (mean ± SE) | 21.5 ± 2.3 | 55.4 ± 2.3 | <.0001 |
EGD, esophagogastroduodenoscopy; GERD, gastroesophageal reflux disease; SE, standard error. |
Discussion
We examined differences in patients’ experiences during EGD when a relatively thin scope was used without sedation vs a conventional wider scope with sedation. We expected the ultrathin scope to be preferable to both patients and physicians because of the reduced risk and lower cost associated with an unsedated procedure performed in an out-patient setting.
This study has major implications for family physicians. First, ultrathin EGD requires less recovery time than the conventional procedure. In addition, unsedated endoscopy does not require continuous cardiopulmonary monitoring.18 In contrast, conventional EGD generally requires a minimum of 2 support personnel: 1 to assist the endoscopist and 1 to monitor vital signs. A third assistant is occasionally needed to monitor patients in recovery. Ultrathin EGD requires only 1 assistant. A thorough exploration of cost savings associated with ultrathin EGD was beyond the scope of this study. A recent study13 found that ultrathin EGD required less procedure time, less time in the procedure room, and less recovery time, with a cost savings of US $125 per procedure. Second, EGD is traditionally limited to being perforen type=med in gastrointestinal suites. Our findings suggested that most patients can tolerate ultrathin EGD in an outpatient setting, thereby offering easier access to the procedure.