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Laparoscopic Cholecystectomy vs Hybrid Natural Orifice Translumenal Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jose F. Noguera, Hospital Son Llatzer
ClinicalTrials.gov Identifier:
NCT00835250
First received: February 2, 2009
Last updated: March 11, 2013
Last verified: March 2013
  Purpose

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 Intervention Phase
Cholelithiasis
Procedure: Transvaginal hybrid NOTES cholecystectomy
Procedure: Cholecystectomy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomized Clinical Trial Comparing Laparoscopic Cholecystectomy and Hybrid Natural Orifice Translumenal Endoscopic Surgery (NOTES)

Resource links provided by NLM:


Further study details as provided by Hospital Son Llatzer:

Primary Outcome Measures:
  • Parietal complications after surgery (infection and hernia) [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Surgical pain. General complications. Patient's preferences. [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: February 2009
Study Completion Date: April 2012
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
Additional 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
Study First Received: February 2, 2009
Last Updated: March 11, 2013
Health Authority: Spain: Ministry of Health and Consumption

Keywords provided by Hospital Son Llatzer:
Transvaginal cholecystectomy
NOTES
Minilaparoscopy
Endoscopic surgery
Cholecystectomy
Surgical translumenal endoscopic surgery
Transvaginal translumenal endoscopic surgery

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

ClinicalTrials.gov processed this record on November 24, 2014