Clinical trial NCT01010685: Safety Study of Keyhole Gallbladder Surgery With Removal of Gallbladder Via the Stomach Rather Than Through the Skin
Official title: Safety and Feasibility Trial of Laparoscopic Small Port Cholecystectomy With Transgastric Gallbladder Recovery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Gallstones
Keywords: Natural Orifice Transluminal Endoscopic Surgery (NOTES)
Transgastric surgery
Surgical Procedures, Minimally Invasive
Lead sponsor: Colchester Hospital University NHS Foundation Trust
Sponsor class: OTHER_GOV
Collaborators: name: Ethicon, Inc.
First posted: 2009-11-10
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 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.
timeFrame: 6 months
Secondary outcomes:
measure: Secondary outcomes include pain levels and cosmetic satisfaction
timeFrame: 6 months
Other outcomes:
Locations:
city: Colchester
country: United Kingdom
facility: Colchester General Hospital
state: Essex
Study officials:
affiliation: Colchester General Hospital
name: Ralph Austin, MS, FRCS
role: PRINCIPAL_INVESTIGATOR
References: