GTLEND: Conventional Laparoscopic Sleeve Gastrectomy Versus Endograb-assisted Single-port Sleeve Gastrectomy
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Lap Patients candidate to bariatric surgery undergoing Conventional laparoscopic Sleeve Gastrectomy |
Procedure: Convetional laparoscopic Sleeve Gastrectomy
Convetional laparoscopic sleeve gastrectomy using 5 ports (incisions) in the abdominal wall
|
| Experimental: SILS Patients candidate to bariatric surgery undergoing Single Incision Laparoscopic Sleeve Gastrectomy supported by Endograb |
Procedure: SILS Sleeve gastrectomy
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:
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Outcome Measures
Primary Outcome Measures
- Postoperative Pain [3 days]
Postoperative pain is assessed using a visual analog scale (VAS)on the first 3 postoperative days
Secondary Outcome Measures
- Cosmestic results [1,3 and 6 months]
Cosmetic results will be assess using visual analog scale (VAS)at 1,3 and 6 months after surgery
- Operative time [Surgery]
operative time will be compared between two thechniques
Other Outcome Measures
- Perioperative complications [1 month]
Appearence of intraoperative and postoperative complications derived from the technique will be recorded an compared with the two techniques.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Body Mass Index > 40
-
Body Mass Index > 35 with 2 mayor comorbidities
Exclusion Criteria:
-
Severe gastroesophageal reflux
-
Esophagitis grade B or higher
-
Midline periumbilical incision
-
Umbilical hernia >4cms.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Universitario Virgen del Rocio | Seville | Spain | 41013 |
Sponsors and Collaborators
- Hospitales Universitarios Virgen del Rocío
Investigators
- Principal Investigator: Morales Conde Salvador, phD, Hospital Universitario Virgen del Rocio
- Study Chair: Alarcón del Agua Isaías, PhD, Hospital Universitario Virgen del Rocio
Study Documents (Full-Text)
None provided.More Information
Publications
- Feliu-Palà X, Martín-Gómez M, Morales-Conde S, Fernández-Sallent E. The impact of the surgeon's experience on the results of laparoscopic hernia repair. Surg Endosc. 2001 Dec;15(12):1467-70.
- Martín-Cartes J, Morales-Conde S, Suárez-Grau J, López-Bernal F, Bustos-Jiménez M, Cadet-Dussort H, Socas-Macías M, Alamo-Martínez J, Tutosaus-Gómez JD, Morales-Mendez S. Use of hyaluronidase cream to prevent peritoneal adhesions in laparoscopic ventral hernia repair by means of intraperitoneal mesh fixation using spiral tacks. Surg Endosc. 2008 Mar;22(3):631-4.
- Morales-Conde S, García Moreno J, Cañete Gómez J, Barranco Moreno A, Socas Macías M. [Single incision laparoscopic right hemicolectomy due to cancer of the colon]. Cir Esp. 2010 Aug;88(2):129-31. doi: 10.1016/j.ciresp.2009.07.016. Epub 2009 Oct 31. Spanish.
- GTL-EG-01