Last reviewed · How we verify
NCT06151912
The Effect of Staple Line Reinforcement Procedures on Postoperative Nausea and Vomiting in Sleeve Gastrectomy
NA trial testing Postoperative Nausea and Vomiting scala in Bariatric Surgical Procedures in 30 participants. Status unknown.
30 June 2024
Quick facts
| Lead sponsor | Sakarya University |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 30 |
| Start date | 1 June 2023 |
| Primary completion | 30 June 2024 |
| Estimated completion | 30 July 2024 |
| Sites | 1 location across Turkey (Türkiye) |
Drugs / interventions tested
- Postoperative Nausea and Vomiting scala
- Quality of life
Conditions studied
- Bariatric Surgical Procedures — all drugs for Bariatric Surgical Procedures →
- Nausea, Postoperative — all drugs for Nausea, Postoperative →
- Vomiting, Postoperative — all drugs for Vomiting, Postoperative →
Sponsor
Sakarya University
Who can join
Adults 18 to 65, any sex, with Bariatric Surgical Procedures or Nausea, Postoperative. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06151912
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Sakarya University trials
Trials by the same sponsor.
- NCT07467655 — THE EFFECT OF DIGITAL STORYTELLING ON NURSING STUDENTS' NURSING PROCESS EDUCATION · NA · not yet recruiting
- NCT07508579 — Effect of Hypothermia on BIS and PSI Correlation During Cardiopulmonary Bypass · not yet recruiting
- NCT07537335 — Knee Osteoartritis Genicular Nerve RF Ablation vs Alcohol Neurolysis · NA · not yet recruiting
- NCT07533669 — Effect of a Preoperative Sensory Modulation Room on Pain, Anxiety, and Sleep in Kidney Transplant Patients · NA · not yet recruiting
- NCT07487324 — Oxygenation in Posterior Stabilization Surgery · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06151912 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sakarya University
- Last refreshed: 30 November 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06151912.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing