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

NCT ID: NCT01583348

Last Updated: 2013-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

33 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Gallstone Disease

Keywords

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transvaginal NOTES cholecystectomy cholangiography symptomatic gallstone disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Women with gallstones

30 women with symptomatic gallstone disease with an indication for elective cholecystectomy

Cholangiography during transvaginal rigid-hybdrid NOTES cholecystectomy

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cantonal Hosptal, Baselland

OTHER

Sponsor Role lead

Responsible Party

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Daniel Steinemann, MD

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andreas Zerz, MD

Role: STUDY_CHAIR

Cantonal Hospital Baselland, Department of Surgery, Bruderholz, Switzerland

Daniel C Steinemann, MD

Role: PRINCIPAL_INVESTIGATOR

Cantonal Hospital Baselland, Department of Surgery, Bruderholz, Switzerland

Önder Ögredici, MD

Role: PRINCIPAL_INVESTIGATOR

Cantonal Hospital Baselland, Department of Surgery, Bruderholz, Switzerland

Locations

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Cantonal Hospital Baselland, Bruderholz, Department of Surgery

Bruderholz, Basel-Landschaft, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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45/12

Identifier Type: -

Identifier Source: org_study_id