A total of 220 patients who underwent their first gastric ESD at the Shenzhen People's Hospital from August 2020 to February 2021 were enrolled in this study. The patients were divided into the relative group and non-relative group according to whether they were accompanied by relatives or not during the perioperative period. During the perioperative period, patients looked after by relatives were set up as the relative group (n=92), and those looked after by non-relatives (hired caregivers) were set up as the non-relative group (n=89). After the detailed screening, 29 patients were excluded from this study. The procedure and results of screening, as well as the patient classification, were shown in the flowchart (Fig. 1). In the relative group, there were 43 males and 49 females aged 30–70, with an average age of 51.9 ± 9.1 years. In terms of disease type, there were four cases of high-grade intraepithelial neoplasia (HGIN), 74 cases of low-grade intraepithelial neoplasia (LGIN), one case of atrophic gastritis, three cases of superficial gastritis, and 10 cases of raised lesions. In the non-relative group, there were 48 males and 41 females aged 30-69, with an average age of 50.1± 7.5 years. In terms of disease type, there were three cases of HGIN, 73 cases of LGIN, four cases of superficial gastritis, and nine cases of raised lesions. The inclusion criteria were set as follows: (1) 18-80 years old; (2) diagnosed with early GI tumors or raised lesions; and (3) receiving ESD treatment and willing to provide informed consent. The exclusion criteria were as follows: (1) patients with severe systemic diseases, including kidney, liver, or heart dysfunction; (2) patients with a previous history of anxiety/depression or admission anxiety/depression score ≥ 8; and (3) patients with Mallory-Weiss syndrome, post-gastrectomy, and coagulation dysfunction. The general data on age, sex, and type of disease between the two groups were not significantly different (p> 0.05) (Table 2). The study was approved by the Ethics Committee of Shenzhen people's Hospital (approval No. of the ethic committee: KY-LL--2020114-01) and registered at ClinicalTrials.gov with the identifier ChiCTR2000032851.
On the following day of admission, all patients were informed of the purpose and procedures of the study. If patients were willing to participate, they were asked to sign an informed consent form. Trained researchers recorded demographic and baseline clinical characteristics of each patient and then assisted the patients to perform the test using the Chinese version of the HADS. Additionally, in the family section of the survey, basic demographic information was collected on the closest family member who accompanied the patient more in the course of hospitalization. Both groups of patients underwent gastric ESD. The patients in the non-relative group were given the routine procedure as follows: the doctor introduced the surgical method to the patient and relieved the patient's tension before the operation. Postoperative proton-pump inhibitor (PPI) therapy can promote the healing of ESD-induced ulcers and reduce the risk of bleeding and abdominal pain. For the relative-group, besides the above-mentioned routine procedures, the accompanying family members were informed to communicate more with the patient, patiently listen to the patient's ideas and concerns, encourage the patient to relax, and provide the patient with a warm, quiet, and comfortable environment. After the surgery, the researchers recorded the HADS scores (the 3rd day after operation) and postoperative complications of both groups.
The severity of the patient’s anxiety and depression was scored with the HADS . HADS is a self-report questionnaire consisting of 14 items, including seven items assessing anxiety (HADS-A) and the other seven items assessing depression (HADS-D). The total score of each subscale obtained ranges from 0 to 21 (higher scores indicate higher anxiety/depression level). In the present study, the demarcation point of 8 was used to diagnose anxiety and depression [20, 24]. The HADS-A1 and HADS-D1 were defined as the anxiety and depression subscales of HADS for the relative group, respectively. HADS-A2 and HADS-D2 were defined as the anxiety and depression subscales of HADS for the non-relative group, respectively.
All data were statistically analyzed using R software (Version 3.5.3). Continuous variables were expressed as means and standard deviations (SD) and compared using the t-test. Categorical data were expressed as percentages and compared using the chi-square test. Normal distribution was assessed by the Kolmogorov-Smirnov test. The independent-samples t-test was used for normally distributed continuous variables. and the Mann-Whitney U-test was used for non-normally distributed continuous variables. Multivariate logistic regression analysis was performed to determine the impact of the factors on postoperative ESD complications. The regression model included the following factors: age, gender, anxiety, depression, pylori infection, type of lesion, and lesion location. Variables reaching significance, or borderline significance, on univariate analysis (p<0.1) were subsequently incorporated into a multivariate model. In all tests, a p value < 0.05 was considered statistically significant.