Demographic and clinical characteristics of the patients at baseline
| Characteristic | G-POEM arm | Control (sham) arm |
| Number of patients | 21 | 20 |
| Sex—number (%) | ||
| Female | 11 (52.4) | 11 (55.0) |
| Male | 10 (47.6) | 9 (45.0) |
| Age—median (Q1–Q3) (years) | 43 (30 – 51) | 51 (45 – 56) |
| BMI – median (Q1–Q3)(kg/m2) | 22 (19 – 28) | 26 (21 – 28) |
| Aetiology—number (%) | ||
| Diabetic; (diabetes type I/diabetes type II, number) | 9 (42.9); (8/1) | 8 (40.0); (6/2) |
| Post-surgical | 6 (28.6) | 7 (35.0) |
| Idiopathic | 6 (28.6) | 5 (25.0) |
| Previous therapy—number (%) | ||
| Metoclopramide | 12 (57.1) | 10 (50.0) |
| Itopride | 11 (52.4) | 10 (50.0) |
| Domperidone | 9 (42.9) | 7 (35.0) |
| Other prokinetics | 3 (14.3) | 2 (10.0) |
| Enteral feeding via nasojejunal/nasogastric tube | 3 (14.3) | 1 (5.0) |
| Recurrent hospitalisation for gastroparesis-related symptom | 8 (38.1) | 7 (35.0) |
| Baseline GCSI score—median (Q1–Q3)* | 3.5 (3.2–3.7) | 3.2 (2.6–3.4) |
| Baseline PAGI-QOL score—median (Q1–Q3)† | 2.1 (1.7–2.7) | 2.5 (1.4–2.8) |
| Baseline 4 hours GES retention—median (Q1–Q3)(%)‡ | 22 (17–32) | 26 (16–42) |
| Pre-procedure DI 40 mL—median (Q1–Q3)(mm2/mm Hg)§ | 5.8 (4.8–9.8) | 5.6 (3.5–6.2) |
Q1–Q3—the first and the third quartile (representing the middle half of the observed values), the difference between Q3 and Q1 is the inter-quartile range.
*GCSI is a validated score assessing symptoms severity in patients with gastroparesis, consisting of nine items (symptoms) and three subscales (nausea/vomiting subscale, postprandial fullness/early satiety subscale and the bloating subscale). Each item can be graded from 0 (no symptom) to 5 (maximally severe symptoms). The total GCSI is calculated as the average of all three subscale averages. GCSI value ranges from 0 (no symptoms) to 5 (maximally severe symptomatology). The index evaluates symptoms during the last 14 days. Only patients with GSCI ˃ 2.3 (indicating severe disease) were eligible for enrolment.
†PAGI-QOL score—a validated QoL questionnaire measures quality of life outcomes in patients with upper gastrointestinal disorders. It contains 30 items with five subscales (daily activities, clothing, diet/food habits, relationship, psychological well-being and distress). A total score is calculated by averaging subscales scores, its value ranges from 0 (perfect QoL) to 5 (worse QoL).
‡GES—is a validated method to demonstrate delayed gastric emptying in patients with gastroparesis. In this trial, all GES were performed according to a standardised method for measuring gastric emptying by scintigraphy; a low-fat, egg-white meal with imaging at 0, 1, 2 and 4 hours after meal ingestion was used for each patient. Only patients with a retention of Tc-99m ˃ 60% at 2 hours and/or≥10% at 4 hours on a standardised sulphur colloid solid phase were eligible for enrolment.
§DI—pyloric distensibility is one among several parameters obtained from measurement of pyloric distensibility by using impendance planimetry principle (Endoflip). Values below 10 mm2/mm Hg are thought to demonstrate a pylorospasm. In this trial, not all patients underwent Endoflip measurement as the method was not available when the trial started.
DI, Distensibility Index; GCSI, Gastroparesis Cardinal Symptom Index; GES, gastric emptying study; G-POEM, endoscopic pyloromyotomy; PAGI-QOL, Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life.