The Effect of Staple Line Reinforcement Procedures on Postoperative Nausea and Vomiting in Sleeve Gastrectomy
NCT ID: NCT06151912
Last Updated: 2023-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
30 participants
INTERVENTIONAL
2023-06-01
2024-07-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Fibrin Glue Group
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.
Postoperative Nausea and Vomiting scala
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 life
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.
Suture Group
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.
Postoperative Nausea and Vomiting scala
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 life
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Postoperative Nausea and Vomiting scala
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 life
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Smoker
* Patients who have previously had another bariatric procedure
* Patients who have previously undergone gastrointestinal system surgery
* Patients with any contraindications for bariatric surgery
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sakarya University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sakarya University
Sakarya, Adapazarı, Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Adem Yuksel, M.D
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
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.
Naeem 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
E-16214662-050.01.04-254590-62
Identifier Type: -
Identifier Source: org_study_id