Gum Chewing Reduces the Risk of Postoperative Ileus After Arthroplasty Procedures in The Elderly Population
Кључне речи
Апстрактан
Опис
Study Enrollment Procedures Enrollment will be a continuous process with screening and enrolling eligible patients admitted through the clinic electively for primary THR. Informed consent will be taken from the patient as per routine protocol before the arthroplasty procedures in the hospital. Research objectives, methodology, risks, and benefits will be explained in detail. Consent for the participation in the study will only be taken by the primary investigator at his clinic or the surgical resident on call preoperatively along with the consent for the surgical procedure.
Pre-Randomization Evaluations Screening The screening will involve the routine history taking and physical examination by the doctor and nursing staff in the clinic. Screening won't involve performing procedures that are not part of routine management. Special attention will be given on assessing the dental history and whether the patient is able to chew gum.
On-study/on-intervention evaluations After screening and eligibility, patients will be randomly allocated by a 1:1 ratio to the gum-chewing (gum) or control (no gum) groups using a computer-generated randomization sequence by the clinical trials unit (CTU), which they will provide to the PI, after patients' admission in the hospital. Patients will be followed from the time they reach the ward after surgery until their hospital discharge, which is usually around 7 days.
Data Collection:
Training of data collectors will be done by the PI to ensure the reliability and validity of the study. Data collectors will be recruited, preferably nurses or residents familiar with the hospital information management system (HIMS), the medical records and the CTU protocols. Training of data collectors will be done, and collectors will be strictly instructed to respect the autonomy of participants. Data collection will be done by the data collectors under the supervision of the PI and CTU. Questionnaires will be checked for consistency and logical data entries. Data entry will be done, and counter checked by the PI at regular intervals.
Data Storage:
Data collected will be coded and kept confidential without the identifiable information of patients. The confidentiality of the study participants will be maintained throughout the study period. Data collected will be kept confidential without identifiable information of patients who are identified by a number assigned. The hard copy forms will be retained in a secured location with the PI after data entry into computer software and will be kept as per hospital protocol. The password-protected drives will be used to store data with only the PI having access to it. The data will be available for AKU ethical review committee on request and might be published in a journal without disclosing any identifiable information of patients. Filled questionnaires will be stored for 5 years after the study is completed as per the policy of the institute.
Sample Size:
To the best of author's knowledge, this is the first research to study the effect of the gum-chewing post-arthroplasty procedure on time to flatus. Literature reported numerous studies on the same objective but only on post abdominal and colorectal surgery patients which gave minimum mean time to flatus post-surgery of 67 hours [3]. In arthroplasty, no handling of abdominal viscera is done, and the investigators assume the time of bowel return to function is considerably less. Hence, considering the rarity of previous literature and the number of cases to be operated in 6 months, investigators decided to recruit and study all the eligible patients during the study period from July 2020 to December 2020. The expected number of patients will be of 50 patients in each arm.
Plan of Analysis:
Statistical analysis will be done by using STATA software version 15. Mean ± SD will be computed for all the normally distributed quantitative variables. The median and interquartile range would be reported for the non-normally distributed quantitative variables. The categorical variables would be expressed in frequencies and percentages. Length of stay will be calculated by Kaplan-Meier analysis, with an unadjusted comparison of groups by mantel-cox log-rank test. Risk ratios for the time-to-become ileus free and time-to-discharge from the hospital will be calculated by cox proportional hazard regression model, considering the following independent variables: age, gender, operation type, diabetes mellitus, preoperative cardiovascular disease (ischemia /heart failure/dysrhythmias), PCA opiate use and presence/absence of chewing gum.
Датуми
Последња верификација: | 06/30/2020 |
Фирст Субмиттед: | 05/31/2020 |
Предвиђена пријава послата: | 07/26/2020 |
Прво објављено: | 07/27/2020 |
Послато последње ажурирање: | 07/26/2020 |
Последње ажурирање објављено: | 07/27/2020 |
Стварни датум почетка студије: | 08/31/2020 |
Процењени датум примарног завршетка: | 05/31/2021 |
Предвиђени датум завршетка студије: | 08/31/2021 |
Стање или болест
Интервенција / лечење
Behavioral: Interventional Arm
Фаза
Групе руку
Арм | Интервенција / лечење |
---|---|
Experimental: Interventional Arm the patients in this arm will receive the post-operative oral feeding along with chewing gum which they'll be required to chew for at least 15 minutes before their meal 3 times a day | Behavioral: Interventional Arm The intervention would be chewing gum. The patients in the intervention arm would be asked to chew gum for 15 minutes before meals thrice a day. |
No Intervention: Control Arm The patients in this arm will only receive the post-operative oral feeding |
Критеријуми
Узраст подобан за студирање | 50 Years До 50 Years |
Полови подобни за студирање | All |
Прихвата здраве волонтере | да |
Критеријуми | Inclusion Criteria: - Adult patients aged 50-70 years - Undergoing elective primary hip arthroplasty surgery - ASA grade I, II, and III - The patients undergoing general anesthesia with/without neuraxial anesthesia Exclusion Criteria: - Patients refusing to consent - Patients already having an established nasogastric (NG) tube/gastrostomy feeding, or unsafe/unable to swallow due to any neurological condition - Patients with documented bowel disease other than peptic ulcers - History of chronic constipation more than 3 days before surgery - Inability to chew gum due to dental issues - traumatic and revision cases of arthroplasty - adjuvant surgical procedures (abdominal, thoracic, etc.) besides the primary arthroplasty procedure will also be excluded from the study. |
Исход
Примарне мере исхода
1. Passage of Flatus [up to 12 hrs post-operatively]
Секундарне мере исхода
1. passage of stool [up to 24 hrs post-operatively]