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

NCT01583348 | Completed

• 1 other identifier: 45/12
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gallstone Disease

Keywords

transvaginal; NOTES; cholecystectomy; cholangiography; symptomatic gallstone disease

Outcome Measures

Primary Outcomes (1)

• Number of patients with successful introduction of cholangiography catheter into cystic duct (yes/no)

  Was the introduction of the cholangiography catheter into the cystic duct successfull during transvaginal rigid-hybrid cholecystectomy.

  intraoperative

Secondary Outcomes (3)

• Time required for cholangiography

  intraoperative

• Intraoperative complications

  intraoperative

• postoperative complications

  within 6 weeks from surgery

Study Arms (1)

Women with gallstones

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

Procedure: Cholangiography during transvaginal rigid-hybdrid NOTES cholecystectomy

Interventions

Cholangiography during transvaginal rigid-hybdrid NOTES cholecystectomy 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.

Women with gallstones

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with symptomatic gallstone disease with an indication for elective cholecystectomy

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cantonal Hosptal, Baselland: lead

Study Sites (1)

Cantonal Hospital Baselland, Bruderholz, Department of Surgery

Bruderholz, Basel-Landschaft, 4101, Switzerland

Location

MeSH Terms

Conditions

Cholelithiasis

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Andreas Zerz, MD

  Cantonal Hospital Baselland, Department of Surgery, Bruderholz, Switzerland

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: April 20, 2012
• First Posted: April 24, 2012
• Study Start: April 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: April 1, 2013
• Last Updated: April 30, 2013

Record last verified: 2013-04

Locations

CH (1)