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Safety Study of Keyhole Gallbladder Surgery With Removal of Gallbladder Via the Stomach Rather Than Through the Skin

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Ethicon, Inc.
Information provided by (Responsible Party):
Mr Ralph Austin, Colchester Hospital University NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01010685
First received: November 7, 2009
Last updated: September 10, 2011
Last verified: September 2011
History of Changes
  Purpose

The benefits of laparoscopic ("minimally invasive" or "keyhole") surgery for gallbladder removal (cholecystectomy) over open surgical procedures in terms of significant reductions in pain, scarring and recovery time are well accepted. In a conventional laparoscopic cholecystectomy however, the excised gallbladder still has to be extracted through the abdominal wall skin via a laparoscopic port site using an incision of 10mm or greater. Despite being much smaller than that required for open surgery, this incision is painful, leaves a scar and can result in a port site hernia to follow requiring further surgery to repair it. Recent attempts to further reduce the invasiveness of the surgical procedure have suggested performing the operation via an endoscope passed through the mouth and through an incision in the stomach wall - so called Natural Orifice Translumenal Endoscopic Surgery (NOTES). Unlike a skin incision, an incision in the wall of the stomach (gastrotomy) should give no pain, visible scar or herniation risk yet still allow access to the peritoneal cavity for surgical procedures such as cholecystectomy. Against this, it has the potential risks of contamination and leakage of gastric contents into the peritoneal cavity. Whilst the limitations of present technology make it very difficult to perform an entire cholecystectomy through the stomach wall in patients, endoscopic methods for closing a gastrotomy are available that are approved for use in patients (CE marked) and it is hypothesised that removing the excised gallbladder through the stomach in this way would avoid the problems of extracting it through the abdominal wall described above. Data are required to determine whether the extraction of the gallbladder via a gastrotomy rather than through the skin is safe, producing smaller scars and a better cosmetic result. A secondary endpoint would be to assess possible reductions in pain and recovery from this less invasive approach.


Condition Intervention
Cholecystectomy
 Procedure: Recovery of gallbladder via gastrotomy instead of via the skin

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Feasibility Trial of Laparoscopic Small Port Cholecystectomy With Transgastric Gallbladder Recovery

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Further study details as provided by Colchester Hospital University NHS Foundation Trust:

Primary Outcome Measures:
  • This is a pilot study aimed at examining the outcomes of gallbladder recovery through a gastrotomy, concentrating on safety. The main outcome is presence of surgical complications. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Secondary outcomes include pain levels and cosmetic satisfaction [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: December 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Recovery of gallbladder via gastrotomy instead of via the skin
    The gallbladder is dissected as for a standard laparoscopic cholecystectomy but is then recovered via a hole in the stomach created and closed endoscopically rather than through the skin as in the standard fashion
  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Fit patients, avoiding extremes of age, with uncomplicated gallstone disease requiring elective laparoscopic cholecystectomy.

Exclusion Criteria:

  • Direct healthcare team deny permission to approach patient for trial.
  • Patient request / preference.
  • Age (< 21 or > 65 yrs old).
  • Co-morbidity (ASA level 3 or above).
  • BMI > 32.
  • Complicated gallstone disease (eg bile duct stones/ERCP/pancreatitis).
  • Gallstones ≥ 18 mm size (too large to recover via oesophagus).
  • Pregnancy.
  • Previous gastric or upper abdominal surgery (alterations in gastric anatomy or adhesions preventing safe gastrotomy).
  • Emergency procedure.
  • Planned other operation during cholecystectomy.
  • Inability to consent or psychiatric or addiction problems relevant to surgery.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01010685

Locations
United Kingdom
Colchester General Hospital
Colchester, Essex, United Kingdom, CO4 5JL
Sponsors and Collaborators
Colchester Hospital University NHS Foundation Trust
Ethicon, Inc.
Investigators
Principal Investigator: Ralph Austin, MS, FRCS Colchester General Hospital
  More Information

No publications provided

Responsible Party: Mr Ralph Austin, Consultant laparoscopic surgeon, Colchester Hospital University NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01010685     History of Changes
Other Study ID Numbers: 09/H0302/104
Study First Received: November 7, 2009
Last Updated: September 10, 2011
Health Authority: United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

Keywords provided by Colchester Hospital University NHS Foundation Trust:
Natural Orifice Transluminal Endoscopic Surgery (NOTES)
Transgastric surgery
Surgical Procedures, Minimally Invasive

ClinicalTrials.gov processed this record on June 17, 2013