Hospital Universitario Virgen del Rocio
Seville, 41013, Spain
NCT Number: NCT02023294
Bariatric surgery has been established as the best treatment for morbid obesity, compared with diet or medical treatment. Laparoscopic approach have improved the results of this surgery in terms of postoperative pain, reduction in the number of complications and hospital stay, as well as better cosmetic results. Conventional laparoscopic technique requires five to seven abdominal incisions to facilitate placement of the multiple trocars. New Single Incision Laparoscopic Surgery (SILS)has been developed as a new technique where only one incision is needed for the introduction of all trocars. Altough this technique can be performed with conventional laparoscopic instruments, new devides have been developed for facilitate this operations by SILS. The investigators think that reducing the number of incision would decrease the postoperative pain and improve cosmetic results in our patients, being a safe and technically feasible intervention supported by these special devices.
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Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Seville, 41013, Spain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Convetional laparoscopic sleeve gastrectomy using 5 ports (incisions) in the abdominal wall
Single incision Sleeve gastrectomy using only one port (incision) on the abdominal wall assisted by an special Traction Device for single port surgery (Endograb)
Other names: Endograb™ (Virtual Ports, Misgav, Israel)
Time frame: 3 days
Postoperative pain is assessed using a visual analog scale (VAS)on the first 3 postoperative days
Time frame: 1,3 and 6 months
Cosmetic results will be assess using visual analog scale (VAS)at 1,3 and 6 months after surgery
Time frame: Surgery
operative time will be compared between two thechniques
Time frame: 1 month
Appearence of intraoperative and postoperative complications derived from the technique will be recorded an compared with the two techniques.
Hospitales Universitarios Virgen del Rocío
Other
Prospective Randomized Clinical Trial Comparing COnventional Laparoscopic Sleeve Gastrectomy Versus Endograb-assisted Single-port Sleeve Gastrectomy
Acronym: GTLEND
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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