Elective Laparoscopic CholecystectomyNCT06069557
The Effect of Respiratory Exercises on Abdominal Distension in Laparoscopic Cholecystectomy Patients
A study testing Respiratory exercise in people with Elective Laparoscopic Cholecystectomy, run by Çanakkale Onsekiz Mart University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Elective Laparoscopic Cholecystectomy
- What is being tested?
- Respiratory exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Sep 2023to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteer Aged between 18-65 years Comprehensible verbal communication
Who cannot join
- Patients with hearing problems Unstable hemodynamics
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bursa City Hospital
Bursa, Bursa Center, 16110
About this study
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
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.
Read the 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
- Being tested
- Respiratory exercise
- Keywords
- Laparoscopic cholecystectomy, Pneumoperitoneum, Shoulder pain, Deep breathing exercises, incentive spirometry
- Medical subject headings
- Pneumoperitoneum, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory exerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | There will be no intervention in this group. |
| Experimental | Experimental | An intervention will be made to this group Receives: Other: Respiratory exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative 1st, 2nd, 3rd, 4th, 4th, 5th, and 6th hours.
Secondary outcomes (2)
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.
Measured: Postoperative 1st, 2nd, 3rd, 4th, 4th, 5th, and 6th hours.
Mobilization time
Mobilization times will be measured in minutes in the first 6 hours in the early postoperative period.
Measured: The first 6 hours in the early postoperative period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start28 Sep 2023
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Elective Laparoscopic CholecystectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Çanakkale Onsekiz Mart University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Araz ASKEROĞLU, Çanakkale Onsekiz Mart University
- Investigators
- Araz Askeroğlu, Ph.D., Principal investigator, Çanakkale Onsekiz Mart University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06069557
- Sponsor's protocol ID
- 21415022005
- Status last verified
- Oct 2023
- First submitted
- 29 Sep 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30782392Bataineh 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.
PubMed 35001953Alaparthi 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.
PubMed 27525116Hsu 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.
PubMed 30298416Tuvayanon 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.
PubMed 29266752Yi 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.
PubMed 28039653Zeeni 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.
PubMed 31996139
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06069557
- Acronym / sponsor ID
- 21415022005
- Conditions
- Elective Laparoscopic Cholecystectomy
- Keywords
- Laparoscopic cholecystectomy, Pneumoperitoneum, Shoulder pain, Deep breathing exercises, incentive spirometry
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Çanakkale Onsekiz Mart UniversityUniversity, hospital or other
- Study start
- 28 Sep 2023 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 6 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –There will be no intervention in this group. |
| Experimental | Experimental | Other: Respiratory exerciseAn intervention will be made to this group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Volunteer Aged between 18-65 years Comprehensible verbal communication
Key exclusion criteria (1 listed)
- Patients with hearing problems Unstable hemodynamics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respiratory exerciseThis 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. | Other | Experimental |
Primary outcome
Post operative abdominal distension
Time frame: Postoperative 1st, 2nd, 3rd, 4th, 4th, 5th, and 6th hours.
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.
2 secondary outcomes
Post operative shoulder pain
Time frame: Postoperative 1st, 2nd, 3rd, 4th, 4th, 5th, and 6th hours.
Mobilization time
Time frame: The first 6 hours in the early postoperative period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Results publication: PubMed 30782392Aydemir 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 publication: PubMed 35001953Bataineh 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 publication: PubMed 27525116Alaparthi 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 publication: PubMed 30298416Hsu 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 publication: PubMed 29266752Tuvayanon 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 publication: PubMed 28039653Yi 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 publication: PubMed 31996139Zeeni 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Araz Askeroğlu, Ph.D. principal investigator
Çanakkale Onsekiz Mart University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory exercise in people with Elective Laparoscopic Cholecystectomy, run by Çanakkale Onsekiz Mart University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post operative abdominal distension (time frame: Postoperative 1st, 2nd, 3rd, 4th, 4th, 5th, and 6th hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06069557, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.