Laparoscopic Cholecystectomy vs Hybrid Natural Orifice Translumenal Surgery
NCT ID: NCT00835250
Last Updated: 2013-03-12
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
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COMPLETED
PHASE3
60 participants
INTERVENTIONAL
2009-02-28
2012-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Laparoscopy
Laparoscopic cholecystectomy
Cholecystectomy
Extirpation of the gallbladder by a surgical procedure
Transumbilical
Transumbilical endoscopic cholecystectomy
Cholecystectomy
Extirpation of the gallbladder by a surgical procedure
Transvaginal
Transvaginal endoscopic cholecystectomy
Transvaginal 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.
Cholecystectomy
Extirpation of the gallbladder by a surgical procedure
Interventions
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Transvaginal 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.
Cholecystectomy
Extirpation of the gallbladder by a surgical procedure
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* unperforated hymen
* presence of illness or condition with an increased risk of pelvic damage with transvaginal approach.
18 Years
65 Years
FEMALE
No
Sponsors
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Hospital Son Llatzer
OTHER
Responsible Party
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Jose F. Noguera
Chief Department of Surgery
Principal Investigators
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Angel Cuadrado, MD PhD
Role: STUDY_CHAIR
Hospital Son Llàtzer
Locations
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Hospital Son Llàtzer
Palma de Mallorca, Balearic Islands, Spain
Countries
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References
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Dolz C, Noguera JF, Martin A, Vilella A, Cuadrado A. [Transvaginal cholecystectomy (NOTES) combined with minilaparoscopy]. Rev Esp Enferm Dig. 2007 Dec;99(12):698-702. doi: 10.4321/s1130-01082007001200004. Spanish.
Noguera JF, Cuadrado A, Dolz C, Olea JM, Garcia JC. Prospective randomized clinical trial comparing laparoscopic cholecystectomy and hybrid natural orifice transluminal endoscopic surgery (NOTES) (NCT00835250). Surg Endosc. 2012 Dec;26(12):3435-41. doi: 10.1007/s00464-012-2359-4. Epub 2012 May 31.
Other Identifiers
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LLATZERNOTES-2
Identifier Type: -
Identifier Source: org_study_id
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