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

Gallstones Clinical Trial

Official title:

Safety and Feasibility Trial of Laparoscopic Small Port Cholecystectomy With Transgastric Gallbladder Recovery

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01010685
• Other study ID #: 09/H0302/104
• Status: Withdrawn
• Phase: N/A
• First received: November 7, 2009
• Last updated: February 4, 2014
• Start date: December 2009
• Est. completion date: March 2014

Study information

• Verified date: February 2014
• Source: Colchester Hospital University NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health ServiceUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gallstones

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Colchester General Hospital	Colchester	Essex

Sponsors (2)

Lead Sponsor	Collaborator
Colchester Hospital University NHS Foundation Trust	Ethicon, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		6 months	Yes
Secondary	Secondary outcomes include pain levels and cosmetic satisfaction		6 months	No