The Effect of Respiratory Exercises on Abdominal Distension in Laparoscopic Cholecystectomy Patients

NCT ID: NCT06069557

Last Updated: 2023-10-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-28
• Study Completion Date: 2024-06-30

Brief Summary

Laparoscopic cholecystectomy is the first-line treatment for symptomatic gallstones. Pneumoperitoneum is the process of expanding the abdominal cavity during the surgical procedure by introducing CO2 gas into the abdomen to widen the field of view and operation. Although CO2 gas is usually released through the subumbilical incision at the end of laparoscopic cholecystectomy, some CO2 gas remains in the peritoneal cavity. This CO2 gas remaining in the peritoneal cavity can cause abdominal distension. Abdominal distension may also increase postoperative pain. In a study, abdominal distension was observed in 42.7% of patients who underwent laparoscopic surgery under general anesthesia. Although CO2 gas is usually released through the subumbilical incision at the end of laparoscopic cholecystectomy, some CO2 gas remains in the peritoneal cavity. This CO2 gas remaining in the peritoneal cavity may cause abdominal distension. On the other hand the incidence of shoulder pain due to pneumoperitoneum and CO2 insufflation after laparoscopic surgery ranges from 35% to 60%. In a study conducted in the Republic of Korea in 2016 in 105 laparoscopic surgery patients, the incidence of shoulder pain after laparoscopy was found to be 80% in the first 24 hours. Inappropriate treatment of postoperative pain in laparoscopic surgery can lead to delayed mobilization, patient dissatisfaction, delayed hospital discharge, and development of chronic pain. In this study, the effect of respiratory exercises and the use of incentive spirometry in the early postoperative period on abdominal distension, shoulder pain and mobilization process in laparoscopic cholecystectomy patients will be examined. We aimed to evaluate the effect of deep breathing exercises and the use of incentive spirometry in the early postoperative period on abdominal distension and shoulder pain due to insufflation procedure in laparoscopic cholecystectomy patients. It is important to take some precautions from the early period to prevent problems that may develop after abdominal surgery. It is thought that the use of deep breathing exercises and incentive spirometry in the early period after laparoscopic cholecystectomy will have an effect on abdominal distension, shoulder pain and mobilization process due to the insufflation procedure.

Detailed Description

Laparoscopic cholecystectomy is the removal of the cystic duct or dissection of the gallbladder with the help of 4 trocar incision lines and intraoperative cholangiography by creating pneumoperitoneum with Veress needle or Hasson technique while the patients are under general anesthesia. Pneumoperitoneum is the process of expanding the abdominal cavity during the surgical procedure by introducing CO2 gas into the abdomen to widen the field of view and operation. With high-pressure insufflators, CO2 is introduced into the abdomen at an intra-abdominal pressure of 15mmHg. The increase in abdominal pressure caused by abdominal distension affects circulation and ventilation by acting directly on the abdominal compartment and indirectly on the thoracic compartment. The increase in abdominal pressure caused by abdominal distension affects circulation and ventilation by acting directly on the abdominal compartment and indirectly on the thoracic compartment. In a study, abdominal distension was observed in 42.7% of patients who underwent laparoscopic surgery under general anesthesia. Although CO2 gas is usually released through the subumbilical incision at the end of laparoscopic cholecystectomy, some CO2 gas remains in the peritoneal cavity. This CO2 gas remaining in the peritoneal cavity may cause abdominal distension. Abdominal distension may also increase postoperative pain. A study results showed that patients with high abdominal distension had higher average postoperative pain levels during the recovery period. It was also found that patients with high levels of postoperative pain caused a delay in readiness for discharge from the recovery room. In addition, inappropriate treatment of postoperative pain in laparoscopic surgery can lead to delayed mobilization, patient dissatisfaction, delayed hospital discharge, and development of chronic pain. Pulmonary atelectasis, decrease in functional residual capacity and high peak airway pressures may occur due to CO2 ensufflation. In addition, an increase in central venous pressure and an increase in arterial and alveolar CO2 can be detected due to increased intra-abdominal pressure and CO2 absorption. Pulmonary complication rates may reach 20% after upper abdominal and thoracic operations, especially due to decreased use of the diaphragm because of pain. In the literature, it was seen that the most common intervention applied after surgery as a nursing practice in the elimination of abdominal distension was to stand up the patient and to make active and passive movements in the bed. Early mobilization, frequent position changes, deep breathing and coughing exercises, and hydration are important in preventing complications that may develop in the respiratory system. The aim of deep breathing exercises is to ensure deep breathing after surgery and to obtain normal breathing patterns.The incentive spirometer is used to assess the patient's inspiratory effort by measuring the volume of inhalation. The incentive spirometer can be used as a convenient tool in rehabilitation as it is inexpensive and easy to administer with no known side effects. It is thought that the use of deep breathing exercises and incentive spirometry in the early period after laparoscopic cholecystectomy will have an effect on abdominal distension, shoulder pain and mobilization process due to the insufflation procedure.

Conditions

Elective Laparoscopic Cholecystectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control

There will be no intervention in this group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Experimental

An intervention will be made to this group

Group Type: EXPERIMENTAL

Respiratory exercise

Intervention Type: OTHER

This group will undergo intervention. The participants will be assessed in terms of abdominal distension and shoulder pain in preoperative period. Respiratory exercise training will be given in the preoperative period. At the 1st, 2nd, 3rd, 4th, 5th, 4th, 5th, and 6th hours postoperatively, 10 deep breathing exercises will be performed in semi fowlers 45º position. During this 6-hour period, the patient will be asked to give 10 deep breaths into the incentive spirometer every 2 hours. Patients will be evaluated for abdominal distension and shoulder pain at the 1st, 2nd, 3rd, 4th, 5th, and 6th hours postoperatively and mobilization times will be measured in the first 6 hours.

Interventions

Respiratory exercise

This group will undergo intervention. The participants will be assessed in terms of abdominal distension and shoulder pain in preoperative period. Respiratory exercise training will be given in the preoperative period. At the 1st, 2nd, 3rd, 4th, 5th, 4th, 5th, and 6th hours postoperatively, 10 deep breathing exercises will be performed in semi fowlers 45º position. During this 6-hour period, the patient will be asked to give 10 deep breaths into the incentive spirometer every 2 hours. Patients will be evaluated for abdominal distension and shoulder pain at the 1st, 2nd, 3rd, 4th, 5th, and 6th hours postoperatively and mobilization times will be measured in the first 6 hours.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Volunteer Aged between 18-65 years Comprehensible verbal communication

Exclusion Criteria

Patients with hearing problems Unstable hemodynamics

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Çanakkale Onsekiz Mart University

OTHER

Sponsor Role: lead

Responsible Party

Araz ASKEROĞLU

Assoc. Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Araz Askeroğlu, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Çanakkale Onsekiz Mart University

Locations

Bursa City Hospital

Bursa, Bursa Center, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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Reference Type: RESULT

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Reference Type: RESULT

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Other Identifiers

21415022005

Identifier Type: -

Identifier Source: org_study_id