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Technical Feasibility of Routine Intraoperative Cholangiography During Elective Rigid-hybrid Transvaginal Natural Orifice Transluminal Endoscopic Cholecystectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daniel Steinemann, MD, Cantonal Hosptal, Baselland
ClinicalTrials.gov Identifier:
NCT01583348
First received: April 20, 2012
Last updated: April 28, 2013
Last verified: April 2013
History of Changes
  Purpose

While gold standard in the treatment of symptomatic gall stones is laparoscopic cholecystectomy with instruments introduced through multiple abdominal wall incisions, transvaginal access to the peritoneal cavity offers an alternative avoiding injury of the abdominal wall. Transvaginal hybrid-NOTES cholecystectomy has been demonstrated effective and safe. However it has not been demonstrated up-to-date if intraoperative cholangiography is feasible during such procedure. This observational case series describes success and technical feasibility of intraoperative cholangiography during transvaginal cholecystectomy. The investigators hypothesis is that cholangiography is feasible equal to conventional laparoscopic cholecystectomy.


Condition Intervention
Gallstone Disease
 Procedure: Cholangiography during transvaginal rigid-hybdrid NOTES cholecystectomy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: An Open Case Series About Technical Feasibility of Routine Intraoperative Cholangiography (IOC) During Elective Rigid-hybrid Transvaginal Natural Orifice Transluminal Endoscopic Cholecystectomy (tvNCC)

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy Gallstones
U.S. FDA Resources

Further study details as provided by Cantonal Hosptal, Baselland:

Primary Outcome Measures:
  • Number of patients with successful introduction of cholangiography catheter into cystic duct (yes/no) [ Time Frame: intraoperative ] [ Designated as safety issue: No ]
    Was the introduction of the cholangiography catheter into the cystic duct successfull during transvaginal rigid-hybrid cholecystectomy.


Secondary Outcome Measures:
  • Time required for cholangiography [ Time Frame: intraoperative ] [ Designated as safety issue: No ]
    From incision of the cystic duct to clipping of the cystic duct

  • Intraoperative complications [ Time Frame: intraoperative ] [ Designated as safety issue: Yes ]
  • postoperative complications [ Time Frame: within 6 weeks from surgery ] [ Designated as safety issue: Yes ]

Enrollment: 33
Study Start Date: April 2012
Study Completion Date: April 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Women with gallstones
30 women with symptomatic gallstone disease with an indication for elective cholecystectomy
 Procedure: Cholangiography during transvaginal rigid-hybdrid NOTES cholecystectomy
During transvaginal rigid-hybrid NOTES cholecystectomy a intraoperative cholangiography is performed. After dissection of the Calot's triangle and distal clipping of the cystic duct, the cystic duct is incised and a regular cholangiography catheter is inserted. Contrast is injected and an image is obtained using an image-converter. After extraction of the catheter the cystic duct is clipped proximally. This intervention is performed in all patients included in the study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women with symptomatic gallstone disease with an indication for elective cholecystectomy

Criteria

Inclusion Criteria:

  • symptomatic gallstone disease
  • age > 18 years
  • written informed consent

Exclusion Criteria:

  • age < 18 years
  • not able to understand informed consent
  • pregnancy
  • vaginal atresia
  • florid vaginal infection
  • gynecological neoplasia
  • allergy to Iod
  • missing informed consents
  • emergency procedure
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01583348

Locations
Switzerland
Cantonal Hospital Baselland, Bruderholz, Department of Surgery
Bruderholz, Baselland, Switzerland, 4101
Sponsors and Collaborators
Cantonal Hosptal, Baselland
Investigators
Study Chair: Andreas Zerz, MD Cantonal Hospital Baselland, Department of Surgery, Bruderholz, Switzerland
Principal Investigator: Daniel C Steinemann, MD Cantonal Hospital Baselland, Department of Surgery, Bruderholz, Switzerland
Principal Investigator: Önder Ögredici, MD Cantonal Hospital Baselland, Department of Surgery, Bruderholz, Switzerland
  More Information

No publications provided

Responsible Party: Daniel Steinemann, MD, Principle Investigator, Cantonal Hosptal, Baselland
ClinicalTrials.gov Identifier: NCT01583348     History of Changes
Other Study ID Numbers: 45/12
Study First Received: April 20, 2012
Last Updated: April 28, 2013
Health Authority: Switzerland: Ethikkommission

Keywords provided by Cantonal Hosptal, Baselland:
transvaginal
NOTES
cholecystectomy
cholangiography
symptomatic gallstone disease

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

ClinicalTrials.gov processed this record on May 16, 2013