GallstonesNCT01010685
Safety Study of Keyhole Gallbladder Surgery With Removal of Gallbladder Via the Stomach Rather Than Through the Skin
A study testing Recovery of gallbladder via gastrotomy instead of via the skin in people with Gallstones, run by Colchester Hospital University NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Gallstones
- What is being tested?
- Recovery of gallbladder via gastrotomy instead of via the skin
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2009to Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fit patients, avoiding extremes of age, with uncomplicated gallstone disease requiring elective laparoscopic cholecystectomy.
Who cannot join
- 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).
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Colchester General Hospital
Colchester, Essex, CO4 5JL
About this study
Official title: Safety and Feasibility Trial of Laparoscopic Small Port Cholecystectomy With Transgastric Gallbladder Recovery
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
- Being tested
- Recovery of gallbladder via gastrotomy instead of via the skin
- Keywords
- Natural Orifice Transluminal Endoscopic Surgery (NOTES), Transgastric surgery, Surgical Procedures, Minimally Invasive
- Medical subject headings
- Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recovery of gallbladder via gastrotomy instead of via the skinProcedure or surgery
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
Secondary outcomes include pain levels and cosmetic satisfaction
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2009 (estimated)
- Study startDec 2009
- Primary completionMar 2014 (estimated)
- Study completionMar 2014 (estimated)
Why it stopped: Specialised equipment required withdrawn from market
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GallstonesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colchester Hospital University NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- Ethicon, Inc.
- Responsible party
- Principal investigator, Mr Ralph Austin, Colchester Hospital University NHS Foundation Trust
- Investigators
- Ralph Austin, MS, FRCS, Principal investigator, Colchester General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01010685
- Sponsor's protocol ID
- 09/H0302/104
- Status last verified
- Feb 2014
- First submitted
- 7 Nov 2009
- Last updated
- 5 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility Trial of Laparoscopic Small Port Cholecystectomy With Transgastric Gallbladder Recovery
- ClinicalTrials.gov ID
- NCT01010685
- Acronym / sponsor ID
- 09/H0302/104
- Conditions
- Gallstones
- Keywords
- Natural Orifice Transluminal Endoscopic Surgery (NOTES), Transgastric surgery, Surgical Procedures, Minimally Invasive
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Specialised equipment required withdrawn from market
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Colchester Hospital University NHS Foundation TrustOther government
- Collaborators
- Ethicon, Inc.
- Study start
- Dec 2009
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 10 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Fit patients, avoiding extremes of age, with uncomplicated gallstone disease requiring elective laparoscopic cholecystectomy.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recovery of gallbladder via gastrotomy instead of via the skinThe 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 | Procedure or surgery | – |
Primary outcome
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
1 secondary outcome
Secondary outcomes include pain levels and cosmetic satisfaction
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2014.
Related trials for Gallstones
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ralph Austin, MS, FRCS principal investigator
Colchester General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recovery of gallbladder via gastrotomy instead of via the skin in people with Gallstones, run by Colchester Hospital University NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2014.