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NCT Number: NCT01583348

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

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.

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Key information

Conditions

Gallstone Disease Biliary Tract Diseases Cholelithiasis Digestive System Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Cantonal Hospital Baselland, Bruderholz, Department of Surgery

Bruderholz, Basel-Landschaft, 4101, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Time required for cholangiography

    Time frame: intraoperative

    From incision of the cystic duct to clipping of the cystic duct

  2. Intraoperative complications

    Time frame: intraoperative

  3. postoperative complications

    Time frame: within 6 weeks from surgery

Sponsors and collaborators

Lead sponsor

Cantonal Hosptal, Baselland

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Apr 24, 2012
Registry last updated
Apr 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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