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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):
Jose F. Noguera, Hospital Son Llatzer

Tracking Information
First Submitted Date  ICMJE February 2, 2009
First Posted Date  ICMJE February 3, 2009
Last Update Posted Date March 12, 2013
Study Start Date  ICMJE February 2009
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 2, 2009)
Parietal complications after surgery (infection and hernia) [ Time Frame: One year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00835250 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2009)
Surgical pain. General complications. Patient's preferences. [ Time Frame: One year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Laparoscopic Cholecystectomy vs Hybrid Natural Orifice Translumenal Surgery
Official Title  ICMJE Prospective Randomized Clinical Trial Comparing Laparoscopic Cholecystectomy and Hybrid Natural Orifice Translumenal Endoscopic Surgery (NOTES)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cholelithiasis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Laparoscopy
    Laparoscopic cholecystectomy
    Intervention: Procedure: Cholecystectomy
  • Experimental: Transumbilical
    Transumbilical endoscopic cholecystectomy
    Intervention: Procedure: Cholecystectomy
  • Experimental: Transvaginal
    Transvaginal endoscopic cholecystectomy
    Interventions:
    • Procedure: Transvaginal hybrid NOTES cholecystectomy
    • Procedure: Cholecystectomy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 2, 2009)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2012
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00835250
Other Study ID Numbers  ICMJE LLATZERNOTES-2
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jose F. Noguera, Hospital Son Llatzer
Study Sponsor  ICMJE Hospital Son Llatzer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Angel Cuadrado, MD PhD Hospital Son Llàtzer
PRS Account Hospital Son Llatzer
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP