Cholelithiasis
Conditions
Keywords
Transvaginal cholecystectomy, NOTES, Minilaparoscopy, Endoscopic surgery, Cholecystectomy, Surgical translumenal endoscopic surgery, Transvaginal translumenal endoscopic surgery
Brief summary
The purpose of the study is to determine the feasibility of cholecystectomy made by a transvaginal approach with a NOTES procedure (natural orifice translumenal endoscopic surgery).
Detailed description
Natural orifice transluminal endoscopic surgery (NOTES) makes it possible to perform intraperitoneal surgical procedures with a minimal number of access points in the abdominal wall. At the present time these procedures are hybrids. It is expected a better cosmetic result and lower incidence in parietal complications in front of laparoscopic cholecystectomy, but is necessary to investigate that these benefits should not be associated with complications of the new access to abdominal cavity. Methods. Prospective randomized clinical series of 60 female patients with gallstones that underwent endoscopic surgery, 20 of them operated with conventional laparoscopic approach, 20 by transumbilical endoscopic approach and 20 of them by transvaginal endoscopic approach. Variables as surgical wound infection, urinary tract infection, evisceration, hernia, mortality and other complications will be analyzed.
Interventions
PROCEDURETransvaginal hybrid NOTES cholecystectomy
Cholecystectomy performed by using a combination of working tools inserted through the entry port for the minilaparoscopy and the videogastroscope, inserted into peritoneal cavity by transvaginal approach. The gallbladder is removed transvaginally through the videogastroscope.
PROCEDURECholecystectomy
Extirpation of the gallbladder by a surgical procedure
Sponsors
Hospital Son Llatzer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* age over 18 and under 65 * symptomatic cholelithiasis with an indication for performing laparoscopic surgery * absence of any gynecological condition that could complicate the procedure (pelvic inflammatory disease or endometriosis) * perforated hymen * agreement on the patient's part not to use the vagina for two weeks after the surgery * signed specific informed consent upon providing specific information about the new surgical approach.
Exclusion criteria
* age under 18 or over 65 * unperforated hymen * presence of illness or condition with an increased risk of pelvic damage with transvaginal approach.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Parietal complications after surgery (infection and hernia) | One year |
Secondary
| Measure | Time frame |
|---|---|
| Surgical pain. General complications. Patient's preferences. | One year |
Countries
Spain
Outcome results
None listed