The Effect of Respiratory Exercises on Abdominal Distension in Laparoscopic Cholecystectomy Patients
Primary Purpose
Elective Laparoscopic Cholecystectomy
Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Respiratory exercise
Sponsored by
About this trial
This is an interventional supportive care trial for Elective Laparoscopic Cholecystectomy focused on measuring Laparoscopic cholecystectomy, Pneumoperitoneum, Shoulder pain, Deep breathing exercises, incentive spirometry
Eligibility Criteria
Inclusion Criteria: Volunteer Aged between 18-65 years Comprehensible verbal communication Exclusion Criteria: Patients with hearing problems Unstable hemodynamics
Sites / Locations
- Bursa City Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Experimental
Arm Description
There will be no intervention in this group.
An intervention will be made to this group
Outcomes
Primary Outcome Measures
Post operative abdominal distension
In the postoperative period, after the patients come to the clinic, all patients will be examined for abdominal distension and their abdominal circumferences will be measured with a tape measure and will be compared with the preoperative period. Patient's statement will also be asked.
Secondary Outcome Measures
Post operative shoulder pain
In the postoperative period, all patients' shoulder pain will be measured with with the Numeric Pain Rating Scale (NPRS) after the patients come to the clinic. The scale is typically set up on a horizontal line, ranges most commonly from 0-10. Patients are instructed to choose a single number from the scale that best indicates their level of pain.
Mobilization time
Mobilization times will be measured in minutes in the first 6 hours in the early postoperative period.
Full Information
NCT ID
NCT06069557
First Posted
September 29, 2023
Last Updated
October 5, 2023
Sponsor
Çanakkale Onsekiz Mart University
1. Study Identification
Unique Protocol Identification Number
NCT06069557
Brief Title
The Effect of Respiratory Exercises on Abdominal Distension in Laparoscopic Cholecystectomy Patients
Official Title
The Effect of Respiratory Exercises and Incentive Spirometer Use in the Early Postoperative Period on Abdominal Distension, Shoulder Pain and Mobilization Process in Laparoscopic Cholecystectomy Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 28, 2023 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Çanakkale Onsekiz Mart University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elective Laparoscopic Cholecystectomy
Keywords
Laparoscopic cholecystectomy, Pneumoperitoneum, Shoulder pain, Deep breathing exercises, incentive spirometry
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
In our study, there are two groups, one control group and one experimental group. The control group will not be intervened. The experimental group will receive preoperative training about the postoperative intervention and the effect of the intervention will be evaluated in postoperative period.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
156 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
There will be no intervention in this group.
Arm Title
Experimental
Arm Type
Experimental
Arm Description
An intervention will be made to this group
Intervention Type
Other
Intervention Name(s)
Respiratory exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Post operative abdominal distension
Description
In the postoperative period, after the patients come to the clinic, all patients will be examined for abdominal distension and their abdominal circumferences will be measured with a tape measure and will be compared with the preoperative period. Patient's statement will also be asked.
Time Frame
Postoperative 1st, 2nd, 3rd, 4th, 4th, 5th, and 6th hours.
Secondary Outcome Measure Information:
Title
Post operative shoulder pain
Description
In the postoperative period, all patients' shoulder pain will be measured with with the Numeric Pain Rating Scale (NPRS) after the patients come to the clinic. The scale is typically set up on a horizontal line, ranges most commonly from 0-10. Patients are instructed to choose a single number from the scale that best indicates their level of pain.
Time Frame
Postoperative 1st, 2nd, 3rd, 4th, 4th, 5th, and 6th hours.
Title
Mobilization time
Description
Mobilization times will be measured in minutes in the first 6 hours in the early postoperative period.
Time Frame
The first 6 hours in the early postoperative period.
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
18-65
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Volunteer Aged between 18-65 years Comprehensible verbal communication
Exclusion Criteria:
Patients with hearing problems Unstable hemodynamics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Araz Askeroğlu, Ph.D.
Organizational Affiliation
Çanakkale Onsekiz Mart University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bursa City Hospital
City
Bursa
State/Province
Bursa Center
ZIP/Postal Code
16110
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30782392
Citation
Aydemir O, Aslan FE, Karabacak U, Akdas O. Corrigendum to 'The Effect of Exaggerated Lithotomy Position on Shoulder Pain after Laparoscopic Cholecystectomy' Pain Management Nursing 2018;19(6):663-670. Pain Manag Nurs. 2019 Feb;20(1):89. doi: 10.1016/j.pmn.2019.01.002. No abstract available.
Results Reference
result
PubMed Identifier
35001953
Citation
Bataineh AM, Qudaisat IY, Banihani M, Obeidat R, Hamasha HS. Use of intraoperative mild hyperventilation to decrease the incidence of postoperative shoulder pain after laparoscopic gastric sleeve surgery: A prospective randomised controlled study. Indian J Anaesth. 2021 Nov;65(11):806-812. doi: 10.4103/ija.ija_576_21. Epub 2021 Nov 23.
Results Reference
result
PubMed Identifier
27525116
Citation
Alaparthi GK, Augustine AJ, Anand R, Mahale A. Comparison of Diaphragmatic Breathing Exercise, Volume and Flow Incentive Spirometry, on Diaphragm Excursion and Pulmonary Function in Patients Undergoing Laparoscopic Surgery: A Randomized Controlled Trial. Minim Invasive Surg. 2016;2016:1967532. doi: 10.1155/2016/1967532. Epub 2016 Jul 21.
Results Reference
result
PubMed Identifier
30298416
Citation
Hsu KF, Chen CJ, Yu JC, Wu SY, Chen BC, Yang CW, Chen TW, Hsieh CB, Chan DC. A Novel Strategy of Laparoscopic Insufflation Rate Improving Shoulder Pain: Prospective Randomized Study. J Gastrointest Surg. 2019 Oct;23(10):2049-2053. doi: 10.1007/s11605-018-3896-5. Epub 2018 Oct 8.
Results Reference
result
PubMed Identifier
29266752
Citation
Tuvayanon W, Silchai P, Sirivatanauksorn Y, Visavajarn P, Pungdok J, Tonklai S, Akaraviputh T. Randomized controlled trial comparing the effects of usual gas release, active aspiration, and passive-valve release on abdominal distension in patients who have undergone laparoscopic cholecystectomy. Asian J Endosc Surg. 2018 Aug;11(3):212-219. doi: 10.1111/ases.12451. Epub 2017 Dec 20.
Results Reference
result
PubMed Identifier
28039653
Citation
Yi MS, Kim WJ, Kim MK, Kang H, Park YH, Jung YH, Lee SE, Shin HY. Effect of ultrasound-guided phrenic nerve block on shoulder pain after laparoscopic cholecystectomy-a prospective, randomized controlled trial. Surg Endosc. 2017 Sep;31(9):3637-3645. doi: 10.1007/s00464-016-5398-4. Epub 2016 Dec 30.
Results Reference
result
PubMed Identifier
31996139
Citation
Zeeni C, Chamsy D, Khalil A, Abu Musa A, Al Hassanieh M, Shebbo F, Nassif J. Effect of postoperative Trendelenburg position on shoulder pain after gynecological laparoscopic procedures: a randomized clinical trial. BMC Anesthesiol. 2020 Jan 29;20(1):27. doi: 10.1186/s12871-020-0946-9.
Results Reference
result
Learn more about this trial
The Effect of Respiratory Exercises on Abdominal Distension in Laparoscopic Cholecystectomy Patients
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