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

April 28, 2013 updated by: Daniel Steinemann, MD, Cantonal Hosptal, Baselland

An Open Case Series About Technical Feasibility of Routine Intraoperative Cholangiography (IOC) During Elective Rigid-hybrid Transvaginal Natural Orifice Transluminal Endoscopic Cholecystectomy (tvNCC)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

33

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Baselland
      • Bruderholz, Baselland, Switzerland, 4101
        • Cantonal Hospital Baselland, Bruderholz, Department of Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women with symptomatic gallstone disease with an indication for elective cholecystectomy

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with successful introduction of cholangiography catheter into cystic duct (yes/no)
Time Frame: intraoperative
Was the introduction of the cholangiography catheter into the cystic duct successfull during transvaginal rigid-hybrid cholecystectomy.
intraoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time required for cholangiography
Time Frame: intraoperative
From incision of the cystic duct to clipping of the cystic duct
intraoperative
Intraoperative complications
Time Frame: intraoperative
intraoperative
postoperative complications
Time Frame: within 6 weeks from surgery
within 6 weeks from surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

April 20, 2012

First Submitted That Met QC Criteria

April 23, 2012

First Posted (Estimate)

April 24, 2012

Study Record Updates

Last Update Posted (Estimate)

April 30, 2013

Last Update Submitted That Met QC Criteria

April 28, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 45/12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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