Bariatric Surgical ProceduresNCT06151912
The Effect of Staple Line Reinforcement Procedures on Postoperative Nausea and Vomiting in Sleeve Gastrectomy
A study testing Postoperative Nausea and Vomiting scala and Quality of life in people with Bariatric Surgical Procedures and Nausea, Postoperative, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
Obesity is a significant public health problem. The only long-term effective treatment method is surgery. The most common surgical procedure is laparoscopic sleeve gastrectomy (LSG). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bariatric Surgical Procedures, Nausea, Postoperative, Vomiting, Postoperative
- What is being tested?
- Postoperative Nausea and Vomiting scala and Quality of life
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 30 Jul 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a body mass index of 40 kg/m2 and above
Who cannot join
- Patients with hiatal hernia, gastritis or ulcer detected during endoscopy
- Smoker
- Patients who have previously had another bariatric procedure
- Patients who have previously undergone gastrointestinal system surgery
- Patients with any contraindications for bariatric surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sakarya University
Sakarya, Adapazarı, 54100
Adem Yuksel, M.D, +905053455259, ademyuksel@sakarya.edu.tr
About this study
Obesity is a significant public health problem. The only long-term effective treatment method is surgery. The most common surgical procedure is laparoscopic sleeve gastrectomy (LSG). However, after LSG, complications such as gastroesophageal reflux disease (GERD), insufficient weight loss, stenosis in the remnant stomach, and bleeding or leakage in the staple line (SL) may be encountered. The most severe complications are leakage and bleeding in sleeve gastrectomy, which can lead to many morbidities and mortality. Strengthening the staple line is an important option to prevent these complications. Methods such as fibrin adhesives, bioabsorbable patches and stitching of the stapler line are used to strengthen the stapler line.
Nausea and vomiting, which occur in the postoperative period in 40% of patients who have undergone abdominal surgery and constitute a serious problem, are detected at an even higher rate in patients who have undergone bariatric surgery. Additionally, strengthening the staple line with various methods may increase the incidence of nausea and vomiting after LSG. Although there are studies in the literature investigating whether strengthening the staple line with buttress material or suture in laparoscopic sleeve gastrectomy affects the incidence of postoperative nausea and vomiting, there is no study investigating the effect of strengthening the staple line with fibrin glue on the incidence of postoperative nausea and vomiting.
This prospective study aims to reveal whether there is a difference between strengthening the staple line with fibrin glue or suture in LSG regarding the incidence of postoperative nausea and vomiting and its effects on quality of life.
Read the detailed description
Bleeding and leaks may occur in the stapler line after sleeve gastrectomy. To prevent these complications, the staple line can be strengthened. More than 60% of bariatric surgeons perform interventions to strengthen the staple line in sleeve gastrectomy.
Two surgeons will perform the operations. One of the surgeons will suture the staple line. The other will apply fibrin glue to the stapler line.
Study: It will be held between June 2023 and June 2024. The same anaesthesia protocol will be applied to all patients during the surgery; All patients will be administered fentanyl 2 mg kg-1, propofol 2.5 mg kg-1 and rocuronium 0.6 mg kg-1 based on lean body weight (LBW) for anaesthesia induction after 3 minutes of preoxygenation. After orotracheal intubation is performed under the guidance of a video laryngoscope and endotracheal intubation is confirmed, 1.0 Minimum alveolar concentration (MAC) value sevoflurane and 1:1 oxygen-air will be used for anaesthesia maintenance. Additional doses of rocuronium were administered if surgically necessary. Ventilation will be applied with a tidal volume of 6-8 ml kg-1 according to the ideal body weight for lung protective ventilation, along with a respiratory frequency at a level to ensure normocapnia (EtCO2 35-45 mmHg). For intraoperative analgesia, remifentanil infusion will be administered at a 0.1-0.3 mcg kg-1 min-1 dose according to ideal body weight. All patients will be given 0.15 mg kg-1 (maximum 16 mg) of ondansetron as an antiemetic. In recovery, sugammadex will be used at a 4-8 mg kg-1 dose to reverse the neuromuscular blockade. For acute postoperative analgesia, 100 mg tramadol, 1000 mg paracetamol and 50 mg dexketoprofen will be administered. No routine postoperative antiemetic medication will be used.
Quality of life index and nausea and vomiting score survey forms will be filled out for patients in the preoperative period, at the 6th, 24th hour and 1st postoperative hour. According to these filled-out forms, the patient's nausea and vomiting scores and quality of life scores will be calculated. Patients included in both groups will be compared to these scores.
This study aims to determine whether there is a difference in strengthening the staple line with fibrin glue or sutures in sleeve gastrectomy regarding the incidence of postoperative nausea and vomiting and its effects on quality of life.
- Being tested
- Postoperative Nausea and Vomiting scala, Quality of life
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative Nausea and Vomiting scalaOther
The Nausea and Vomiting Intensity Scale will be used. Patients will be evaluated with this scale at 1, 6, 24 hours and one month. According to this scale, A total score of ≥50 at any time during the study period will be defined as clinically significant nausea and vomiting.
Quality of lifeOther
The EuroQol Group (EQ-5D-5L) questionnaire will assess the quality of life in five domains (mobility, personal care, usual activities, pain and anxiety). A higher score indicates more excellent quality of life impairment. The survey will be administered to patients immediately before surgery and 24 hours and four weeks after surgery to establish baseline values.
| Study group | Role | What they receive |
|---|---|---|
| Fibrin Glue Group | Experimental | Sleeve gastrectomy will be performed on morbidly obese patients, starting 3 cm cranial to the pylorus, under the guidance of a 36 F bougie. Then, Fibrin Glue (TisseelTM-Baxter, USA) will be applied to the staple line. Receives: Other: Postoperative Nausea and Vomiting scala; Other: Quality of life |
| Suture Group | Active comparator | Sleeve gastrectomy will be performed on morbidly obese patients, starting 3 cm cranial to the pylorus, under the guidance of a 36 F bougie. Then, the stapler line will be sutured with continuous sutures with 3/0 prolene suture, with the stapler line inverted. Receives: Other: Postoperative Nausea and Vomiting scala; Other: Quality of life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative nausea and vomiting intensity scale (6. hours)
Question 1. Have you vomited or had dry-retching?
- No 0 point
- Once or twice 2 point
- Three or more times 50 points
Question 2. Have you experienced a feeling of nausea? If yes, has your feeling interfered with being able to get out of bed, walking, eating or drinking?
- No 0 point
- Sometimes 1 point
- Often or most of the time 2 point
- All of the time 25 point
Question 3. Has your nausea been mostly:
- Varying ("comes and goes") 1point
- Constant 2 point
Question 4. What was the duration of your feeling of nausea (in hours)?
…, … (hours). If the answer to Q1=c), score=50 Otherwise, select the highest score of Q1 or Q2, the multiply x Q3 x Q4 Postoperative nausea and vomiting intensity score:
Measured: Postoperative 6 hours
Postoperative nausea and vomiting intensity scale (24. hours)
Question 1. Have you vomited or had dry-retching?
- No 0 point
- Once or twice 2 point
- Three or more times 50 points
Question 2. Have you experienced a feeling of nausea? If yes, has your feeling interfered with being able to get out of bed, walking, eating or drinking?
- No 0 point
- Sometimes 1 point
- Often or most of the time 2 point
- All of the time 25 point
Question 3. Has your nausea been mostly:
- Varying ("comes and goes") 1point
- Constant 2 point
Question 4. What was the duration of your feeling of nausea (in hours)?
…, … (hours). If answer to Q1=c), score=50 Otherwise, select the highest score of Q1 or Q2, the multiply x Q3 x Q4
Postoperative nausea and vomiting intensity score:
Measured: Postoperative 24 hours
Postoperative nausea and vomits intensity scale (72. hours)
Question 1. Have you vomited or had dry-retching?
- No 0 point
- Once or twice 2 point
- Three or more times 50 points
Question 2. Have you experienced a feeling of nausea? If yes, has your feeling interfered with being able to get out of bed, walking, eating or drinking?
- No 0 point
- Sometimes 1 point
- Often or most of the time 2 point
- All of the time 25 point
Question 3. Has your nausea been mostly:
- Varying ("comes and goes") 1point
- Constant 2 point
Question 4. What was the duration of your feeling of nausea (in hours)?
…, … (hours). If answer to Q1=c), score=50 Otherwise, select the highest score of Q1 or Q2, the multiply x Q3 x Q4 Postoperative nausea and vomiting intensity score:
Measured: Postoperative 72 hours
Quality of life (index)
The EuroQol Group (EQ-5D-5L) questionnaire will be used to evaluate quality of life.
According to the survey, patients will be evaluated in five areas (mobility, self-care, usual activities, pain, and anxiety).
Measured: Baseline (Index)
Quality of life (24. hours)
The EuroQol Group (EQ-5D-5L) questionnaire will be used to evaluate quality of life.
According to the survey, patients will be evaluated in five areas (mobility, self-care, usual activities, pain, and anxiety).
Measured: Postoperative 24 hours
Quality of life (72. hours)
The EuroQol Group (EQ-5D-5L) questionnaire will be used to evaluate quality of life.
According to the survey, patients will be evaluated in five areas (mobility, self-care, usual activities, pain, and anxiety).
Measured: Postoperative 72 hours
Quality of life (1. month)
The EuroQol Group (EQ-5D-5L) questionnaire will be used to evaluate quality of life.
According to the survey, patients will be evaluated in five areas (mobility, self-care, usual activities, pain, and anxiety).
Measured: Postoperative 1 month
Postoperative nausea and vomiting intensity scale (1. month)
Question 1. Have you vomited or had dry-retching?
- No 0 point
- Once or twice 2 point
- Three or more times 50 points
Question 2. Have you experienced a feeling of nausea? If yes, has your feeling interfered with being able to get out of bed, walking, eating or drinking?
- No 0 point
- Sometimes 1 point
- Often or most of the time 2 point
- All of the time 25 point
Question 3. Has your nausea been mostly:
- Varying ("comes and goes") 1point
- Constant 2 point
Question 4. What was the duration of your feeling of nausea (in hours)?
…, … (hours). If answer to Q1=c), score=50 Otherwise, select the highest score of Q1 or Q2, the multiply x Q3 x Q4
Postoperative nausea and vomiting intensity score:
Measured: Postoperative 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start1 Jun 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bariatric Surgical ProceduresStudies of the same condition, open and under way.
- More trials run by Sakarya UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Morbidly obese patients will undergo sleeve gastrectomy, starting 3 cm cranial to the pylorus, under the guidance of a 36 F bougie. After gastrectomy, fibrin glue will be applied to the stapler line in one of the groups. In the other group, the staple line will be sutured with 3/0 prolene in an inverted manner.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06151912
- Sponsor's protocol ID
- E-16214662-050.01.04-254590-62
- Status last verified
- Nov 2023
- First submitted
- 2 Nov 2023
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ruiz-Tovar J, Zubiaga L, Munoz JL, Llavero C. Incidence of postoperative nausea and vomiting after laparoscopic sleeve gastrectomy with staple line reinforcement with oversewing and staple line inversion vs buttressing material: A randomized clinical trial. Int J Surg. 2018 Nov;59:75-79. doi: 10.1016/j.ijsu.2018.09.010. Epub 2018 Oct 3.
PubMed 30292000Naeem Z, Nie L, Drakos P, Yang J, Gan TJ, Pryor AD, Spaniolas K. The Relationship Between Postoperative Nausea and Vomiting and Early Self-Rated Quality of Life Following Laparoscopic Sleeve Gastrectomy. J Gastrointest Surg. 2021 Aug;25(8):2107-2109. doi: 10.1007/s11605-021-04923-4. Epub 2021 Feb 2. No abstract available.
PubMed 33528788
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Staple Line Reinforcement Procedures on Postoperative Nausea and Vomiting in Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT06151912
- Acronym / sponsor ID
- E-16214662-050.01.04-254590-62
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 30 Nov 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.
Obesity is a significant public health problem. The only long-term effective treatment method is surgery. The most common surgical procedure is laparoscopic sleeve gastrectomy (LSG). However, after LSG, complications such as gastroesophageal reflux disease (GERD), insufficient weight loss, stenosis in the remnant stomach, and bleeding or leakage in the staple line (SL) may be encountered. The most severe complications are leakage and bleeding in sleeve gastrectomy, which can lead to many morbidities and mortality. Strengthening the staple line is an important option to prevent these complications. Methods such as fibrin adhesives, bioabsorbable patches and stitching of the stapler line are used to strengthen the stapler line.
Nausea and vomiting, which occur in the postoperative period in 40% of patients who have undergone abdominal surgery and constitute a serious problem, are detected at an even higher rate in patients who have undergone bariatric surgery. Additionally, strengthening the staple line with various methods may increase the incidence of nausea and vomiting after LSG. Although there are studies in the literature investigating whether strengthening the staple line with buttress material or suture in laparoscopic sleeve gastrectomy affects the incidence of postoperative nausea and vomiting, there is no study investigating the effect of strengthening the staple line with fibrin glue on the incidence of postoperative nausea and vomiting.
This prospective study aims to reveal whether there is a difference between strengthening the staple line with fibrin glue or suture in LSG regarding the incidence of postoperative nausea and vomiting and its effects on quality of life.
Detailed description
Bleeding and leaks may occur in the stapler line after sleeve gastrectomy. To prevent these complications, the staple line can be strengthened. More than 60% of bariatric surgeons perform interventions to strengthen the staple line in sleeve gastrectomy.
Two surgeons will perform the operations. One of the surgeons will suture the staple line. The other will apply fibrin glue to the stapler line.
Study: It will be held between June 2023 and June 2024. The same anaesthesia protocol will be applied to all patients during the surgery; All patients will be administered fentanyl 2 mg kg-1, propofol 2.5 mg kg-1 and rocuronium 0.6 mg kg-1 based on lean body weight (LBW) for anaesthesia induction after 3 minutes of preoxygenation. After orotracheal intubation is performed under the guidance of a video laryngoscope and endotracheal intubation is confirmed, 1.0 Minimum alveolar concentration (MAC) value sevoflurane and 1:1 oxygen-air will be used for anaesthesia maintenance. Additional doses of rocuronium were administered if surgically necessary. Ventilation will be applied with a tidal volume of 6-8 ml kg-1 according to the ideal body weight for lung protective ventilation, along with a respiratory frequency at a level to ensure normocapnia (EtCO2 35-45 mmHg). For intraoperative analgesia, remifentanil infusion will be administered at a 0.1-0.3 mcg kg-1 min-1 dose according to ideal body weight. All patients will be given 0.15 mg kg-1 (maximum 16 mg) of ondansetron as an antiemetic. In recovery, sugammadex will be used at a 4-8 mg kg-1 dose to reverse the neuromuscular blockade. For acute postoperative analgesia, 100 mg tramadol, 1000 mg paracetamol and 50 mg dexketoprofen will be administered. No routine postoperative antiemetic medication will be used.
Quality of life index and nausea and vomiting score survey forms will be filled out for patients in the preoperative period, at the 6th, 24th hour and 1st postoperative hour. According to these filled-out forms, the patient's nausea and vomiting scores and quality of life scores will be calculated. Patients included in both groups will be compared to these scores.
This study aims to determine whether there is a difference in strengthening the staple line with fibrin glue or sutures in sleeve gastrectomy regarding the incidence of postoperative nausea and vomiting and its effects on quality of life.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Morbidly obese patients will undergo sleeve gastrectomy, starting 3 cm cranial to the pylorus, under the guidance of a 36 F bougie. After gastrectomy, fibrin glue will be applied to the stapler line in one of the groups. In the other group, the staple line will be sutured with 3/0 prolene in an inverted manner.
| Arm | Type | Receives |
|---|---|---|
| Fibrin Glue Group | Experimental | Other: Postoperative Nausea and Vomiting scala, Other: Quality of lifeSleeve gastrectomy will be performed on morbidly obese patients, starting 3 cm cranial to the pylorus, under the guidance of a 36 F bougie. Then, Fibrin Glue (TisseelTM-Baxter, USA) will be applied to the staple line. |
| Suture Group | Active comparator | Other: Postoperative Nausea and Vomiting scala, Other: Quality of lifeSleeve gastrectomy will be performed on morbidly obese patients, starting 3 cm cranial to the pylorus, under the guidance of a 36 F bougie. Then, the stapler line will be sutured with continuous sutures with 3/0 prolene suture, with the stapler line inverted. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with a body mass index of 40 kg/m2 and above
Key exclusion criteria (5 listed)
- Patients with hiatal hernia, gastritis or ulcer detected during endoscopy
- Smoker
- Patients who have previously had another bariatric procedure
- Patients who have previously undergone gastrointestinal system surgery
- Patients with any contraindications for bariatric surgery
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 |
|---|---|---|
| Postoperative Nausea and Vomiting scalaThe Nausea and Vomiting Intensity Scale will be used. Patients will be evaluated with this scale at 1, 6, 24 hours and one month. According to this scale, A total score of ≥50 at any time during the study period will be defined as clinically significant nausea and vomiting. | Other | Fibrin Glue Group, Suture Group |
| Quality of lifeThe EuroQol Group (EQ-5D-5L) questionnaire will assess the quality of life in five domains (mobility, personal care, usual activities, pain and anxiety). A higher score indicates more excellent quality of life impairment. The survey will be administered to patients immediately before surgery and 24 hours and four weeks after surgery to establish baseline values. | Other | Fibrin Glue Group, Suture Group |
Primary outcome
Postoperative nausea and vomiting intensity scale (6. hours)
Time frame: Postoperative 6 hours
Question 1. Have you vomited or had dry-retching? 1. No 0 point 2. Once or twice 2 point 3. Three or more times 50 points Question 2. Have you experienced a feeling of nausea? If yes, has your feeling interfered with being able to get out of bed, walking, eating or drinking? 1. No 0 point 2. Sometimes 1 point 3. Often or most of the time 2 point 4. All of the time 25 point Question 3. Has your nausea been mostly: 1. Varying ("comes and goes") 1point 2. Constant 2 point Question 4. What was the duration of your feeling of nausea (in hours)? …, … (hours). If the answer to Q1=c), score=50 Otherwise, select the highest score of Q1 or Q2, the multiply x Q3 x Q4 Postoperative nausea and vomiting intensity score:
Postoperative nausea and vomiting intensity scale (24. hours)
Time frame: Postoperative 24 hours
Question 1. Have you vomited or had dry-retching? 1. No 0 point 2. Once or twice 2 point 3. Three or more times 50 points Question 2. Have you experienced a feeling of nausea? If yes, has your feeling interfered with being able to get out of bed, walking, eating or drinking? 1. No 0 point 2. Sometimes 1 point 3. Often or most of the time 2 point 4. All of the time 25 point Question 3. Has your nausea been mostly: 1. Varying ("comes and goes") 1point 2. Constant 2 point Question 4. What was the duration of your feeling of nausea (in hours)? …, … (hours). If answer to Q1=c), score=50 Otherwise, select the highest score of Q1 or Q2, the multiply x Q3 x Q4 Postoperative nausea and vomiting intensity score:
Postoperative nausea and vomits intensity scale (72. hours)
Time frame: Postoperative 72 hours
Question 1. Have you vomited or had dry-retching? 1. No 0 point 2. Once or twice 2 point 3. Three or more times 50 points Question 2. Have you experienced a feeling of nausea? If yes, has your feeling interfered with being able to get out of bed, walking, eating or drinking? 1. No 0 point 2. Sometimes 1 point 3. Often or most of the time 2 point 4. All of the time 25 point Question 3. Has your nausea been mostly: 1. Varying ("comes and goes") 1point 2. Constant 2 point Question 4. What was the duration of your feeling of nausea (in hours)? …, … (hours). If answer to Q1=c), score=50 Otherwise, select the highest score of Q1 or Q2, the multiply x Q3 x Q4 Postoperative nausea and vomiting intensity score:
Quality of life (index)
Time frame: Baseline (Index)
The EuroQol Group (EQ-5D-5L) questionnaire will be used to evaluate quality of life. According to the survey, patients will be evaluated in five areas (mobility, self-care, usual activities, pain, and anxiety).
Quality of life (24. hours)
Time frame: Postoperative 24 hours
The EuroQol Group (EQ-5D-5L) questionnaire will be used to evaluate quality of life. According to the survey, patients will be evaluated in five areas (mobility, self-care, usual activities, pain, and anxiety).
Quality of life (72. hours)
Time frame: Postoperative 72 hours
The EuroQol Group (EQ-5D-5L) questionnaire will be used to evaluate quality of life. According to the survey, patients will be evaluated in five areas (mobility, self-care, usual activities, pain, and anxiety).
Quality of life (1. month)
Time frame: Postoperative 1 month
The EuroQol Group (EQ-5D-5L) questionnaire will be used to evaluate quality of life. According to the survey, patients will be evaluated in five areas (mobility, self-care, usual activities, pain, and anxiety).
Postoperative nausea and vomiting intensity scale (1. month)
Time frame: Postoperative 1 month
Question 1. Have you vomited or had dry-retching? 1. No 0 point 2. Once or twice 2 point 3. Three or more times 50 points Question 2. Have you experienced a feeling of nausea? If yes, has your feeling interfered with being able to get out of bed, walking, eating or drinking? 1. No 0 point 2. Sometimes 1 point 3. Often or most of the time 2 point 4. All of the time 25 point Question 3. Has your nausea been mostly: 1. Varying ("comes and goes") 1point 2. Constant 2 point Question 4. What was the duration of your feeling of nausea (in hours)? …, … (hours). If answer to Q1=c), score=50 Otherwise, select the highest score of Q1 or Q2, the multiply x Q3 x Q4 Postoperative nausea and vomiting intensity score:
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Background: PubMed 30292000Ruiz-Tovar J, Zubiaga L, Munoz JL, Llavero C. Incidence of postoperative nausea and vomiting after laparoscopic sleeve gastrectomy with staple line reinforcement with oversewing and staple line inversion vs buttressing material: A randomized clinical trial. Int J Surg. 2018 Nov;59:75-79. doi: 10.1016/j.ijsu.2018.09.010. Epub 2018 Oct 3.
- Background: PubMed 33528788Naeem Z, Nie L, Drakos P, Yang J, Gan TJ, Pryor AD, Spaniolas K. The Relationship Between Postoperative Nausea and Vomiting and Early Self-Rated Quality of Life Following Laparoscopic Sleeve Gastrectomy. J Gastrointest Surg. 2021 Aug;25(8):2107-2109. doi: 10.1007/s11605-021-04923-4. Epub 2021 Feb 2. No abstract available.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postoperative Nausea and Vomiting scala and Quality of life in people with Bariatric Surgical Procedures and Nausea, Postoperative, run by Sakarya 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 5 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 30 Nov 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?
Contact Adem Yuksel, M.D (+905053455259, ademyuksel@sakarya.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative nausea and vomiting intensity scale (6. hours) (time frame: Postoperative 6 hours). The study lists 8 primary outcomes in all. 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 NCT06151912, which also lists 2 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 30 Nov 2023.