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Laparoscopic Cholecystectomy vs Hybrid Natural Orifice Translumenal Surgery

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ClinicalTrials.gov Identifier: NCT00835250
Recruitment Status : Completed
First Posted : February 3, 2009
Last Update Posted : March 12, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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).

Condition or disease Intervention/treatment Phase
Cholelithiasis Procedure: Transvaginal hybrid NOTES cholecystectomy Procedure: Cholecystectomy Phase 3

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomized Clinical Trial Comparing Laparoscopic Cholecystectomy and Hybrid Natural Orifice Translumenal Endoscopic Surgery (NOTES)
Study Start Date : February 2009
Primary Completion Date : May 2011
Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gallstones
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Laparoscopy
Laparoscopic cholecystectomy
Procedure: Cholecystectomy
Extirpation of the gallbladder by a surgical procedure
Experimental: Transumbilical
Transumbilical endoscopic cholecystectomy
Procedure: Cholecystectomy
Extirpation of the gallbladder by a surgical procedure
Experimental: Transvaginal
Transvaginal endoscopic cholecystectomy
Procedure: 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.
Other Names:
  • NOTES cholecystectomy
  • Transvaginal cholecystectomy
Procedure: Cholecystectomy
Extirpation of the gallbladder by a surgical procedure


Outcome Measures

Primary Outcome Measures :
  1. Parietal complications after surgery (infection and hernia) [ Time Frame: One year ]

Secondary Outcome Measures :
  1. Surgical pain. General complications. Patient's preferences. [ Time Frame: One year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00835250


Locations
Spain
Hospital Son Llàtzer
Palma de Mallorca, Illes Balears., Spain, 07140
Sponsors and Collaborators
Hospital Son Llatzer
Investigators
Study Chair: Angel Cuadrado, MD PhD Hospital Son Llàtzer
More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jose F. Noguera, Chief Department of Surgery, Hospital Son Llatzer
ClinicalTrials.gov Identifier: NCT00835250     History of Changes
Other Study ID Numbers: LLATZERNOTES-2
First Posted: February 3, 2009    Key Record Dates
Last Update Posted: March 12, 2013
Last Verified: March 2013

Keywords provided by Jose F. Noguera, Hospital Son Llatzer:
Transvaginal cholecystectomy
NOTES
Minilaparoscopy
Endoscopic surgery
Cholecystectomy
Surgical translumenal endoscopic surgery
Transvaginal translumenal endoscopic surgery

Additional relevant MeSH terms:
Cholelithiasis
Cholecystolithiasis
Gallstones
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical