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

NCT ID: NCT01010685

Last Updated: 2014-02-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2014-03-31

Brief Summary

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.

Conditions

Gallstones

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ethicon, Inc.

INDUSTRY

Sponsor Role: collaborator

Colchester Hospital University NHS Foundation Trust

OTHER_GOV

Sponsor Role: lead

Responsible Party

Mr Ralph Austin

Consultant laparoscopic surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ralph Austin, MS, FRCS

Role: PRINCIPAL_INVESTIGATOR

Colchester General Hospital

Locations

Colchester General Hospital

Colchester, Essex, United Kingdom

Countries

United Kingdom

Other Identifiers

09/H0302/104

Identifier Type: -

Identifier Source: org_study_id