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

Gallstone Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01583348
• Other study ID #: 45/12
• Status: Completed
• Phase: N/A
• First received: April 20, 2012
• Last updated: April 28, 2013
• Start date: April 2012
• Est. completion date: April 2013

Study information

• Verified date: April 2013
• Source: Cantonal Hosptal, Baselland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: April 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Gallstone Disease
• Gallstones

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Cantonal Hospital Baselland, Bruderholz, Department of Surgery	Bruderholz	Baselland

Sponsors (1)

Lead Sponsor	Collaborator
Cantonal Hosptal, Baselland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Time required for cholangiography	From incision of the cystic duct to clipping of the cystic duct	intraoperative	No
Secondary	Intraoperative complications		intraoperative	Yes
Secondary	postoperative complications		within 6 weeks from surgery	Yes