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临床试验/CTRI/2024/08/071974
CTRI/2024/08/071974尚未招募不适用

EFFECT OF PREOPERATIVE PATIENT TRAINING ON POST-OPERATIVE RECOVERY IN UPPER ABDOMINAL SURGERY PATIENTS: A RANDOMIZED CONTROLLED TRIAL

DR SHEETAL MALEKAR1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2024年12月2日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
110
试验地点
1
主要终点
POSTOPERATIVE DISCHARGE SCORING TOOL

研究概览

简要总结

BACKGROUND -

Surgical care has a role in treating a broad spectrum of diseases in the alleviation of human suffering.1 The estimated need for surgical procedures worldwide is large and addresses widespread of disease states. Surgery is essential for addressing basic health needs globally, although the degree varies between epidemiological regions of the world and between disease subcategories. Surgical need varies between regions of the world according to disease prevalence and many countries do not meet the basic needs of their populations.1According to WHO, at least 321·5 million surgical procedures would be needed to address the burden of disease for a global population of 6·9 billion. A large volume of surgical need, estimates one procedure per 21 people alive today, with a global rate of surgery of 4664 per 100, 000. After major abdominal surgery, mobilisation and oxygen-hemoglobin saturation were improved, and the frequency of postoperative pulmonary problems was decreased thanks to preoperative chest physical therapy. "Hence, therefore aim of our study to find the effect of structured programme consisting of a combination pre and post-operative Physiotherapy programme in upper abdominal surgery patients.

NEED FOR THE STUDY –

Surgery is a foundational component of health-care systems and it has a direct effect on the respiratory system. It alters postoperative pulmonary function, as observed by impairment of lung volumes such as total lung capacity, vital capacity and tidal volume. Abdominal surgery is the most major surgical procedure performed in developed countries. A postoperative pulmonary complication (PPC) is the most common serious complication after the surgery. As few studies, have only shown the preoperative education or either particularly postoperative physiotherapy programme for abdominal surgery patients. Our study aims to form a structured intervention comprising of pre-operative education and its effect on post-operative pulmonary complications and discharge from hospital.

According to the International Association for the Study of Pain, pain is an unpleasant sensory and emotional experience related to actual or potential tissue damage. Postoperative pain is the most common symptom encountered by hospitalized surgical patients. This increases the prevalence of postoperative morbidity and leads to delayed recovery. For that preoperative education and postoperative physiotherapy programme helps the patient to get recover from pain as soon as possible and leads to reduction in hospital stay. The pre-operative education component will help in patient’s understanding of complications after surgery. The post-operative Physiotherapy exercise programme will focus on improvement of respiratory muscle strength, oxygenation, coughing mechanism, chest wall mobility and lung ventilation, as well as decreasing respiratory work and preventing postoperative pulmonary complications. Preoperative educational training will reduce the incidence of PPC with postoperative interventional programme. Hence, aim of this study find the effect of structured programme consisting of a combination pre and post-operative Physiotherapy programme in upper abdominal surgery patients.

        AIM –To find the effect of a newly structured intervention Physiotherapy programme consisting of a combination of pre and postoperative Physiotherapy in upper abdominal surgery patients.

  **OBJECTIVES-**Primary Objective:

Ø  To find out the effect of pre and post-operative Physiotherapy in upper abdominal surgery patients.

Ø  To minimize hospital stay of patients after the upper abdominal surgery.

Secondary Objective:

Ø  To make information brochure & Audio-visual video containing information of post- operative complications and physiotherapy exercise programme.

Ø  To find out the effect of pre and post-operative Physiotherapy on pain measured with NPRS in abdominal surgery patients.

METHODOLOGY

Ø  Type of data: Data will be primarily collected by principal investigator.

Ø  Study setting – Pravara medical trust hospital (PIMS -DU) Loni

Ø  Study design: A Randomized controlled Trial

Ø  Sample size: 110 participants.

Ø  Sampling method: simple random sampling

Ø  Study duration: 3 years.

 Materials to be used:

·       Consent form

·       Data collection sheet

·       Numerical Pain Rating Scale (NPRS)

·       POPDST (Postoperative physiotherapy discharge scale)

·       Melbourne postoperative Pulmonary complications criteria

·       De Morton Mobility Index (DEMMI)

   OUTCOME MEASURE -1.     Satisfaction: Patient satisfaction of the intervention will be measured at the follow-up visit within 1 week before surgery using a self-reported questionnaire.

2.     NPRS – For post-operative pain at suture site.

3.   POP-DST – To measure PPCs after the surgery.

4.     MGS - To measure PPCs after the surgery.

5.     De Morton Mobility Index (DMEI) – Health Related Quality of life

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Participants with upper abdominal surgery within age group of 18-60 years.
  • Only elective upper abdominal surgery patients are included.
  • Participants who are signed consent form of the study Patients who will be undergoing abdominal surgery after 3 days of enrollment.

排除标准

  • Participants who are not signed consent form of the study Postoperative hemodynamic instability Postoperative ventilators Age more than 60 years Patients stay in the intensive care unit for a longer time during the postoperative period.
  • If patients required organ transplants, required abdominal hernia repairs, unable to ambulate for more than one minute, and will unable to participate in a single physiotherapy preoperative session.
  • Patients undergoing video assisted laparoscopy surgery.

结局指标

主要结局

POSTOPERATIVE DISCHARGE SCORING TOOL

时间窗: 1 DAY AND 8 DAY

次要结局

  • DEMORTON MOBILITY INDEX(1 DAY AND 8 DAY OF INTERVENTION)

研究者

发起方
DR SHEETAL MALEKAR
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

DR SHEETAL MALEKAR

PRAVARA INSTITUTE OF MEDICAL SCIENCES

研究点 (1)

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