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

February 4, 2014 updated by: Mr Ralph Austin, Colchester Hospital University NHS Foundation Trust

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Essex
      • Colchester, Essex, United Kingdom, CO4 5JL
        • Colchester General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Secondary outcomes include pain levels and cosmetic satisfaction
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Colchester Hospital University NHS Foundation Trust

Collaborators

Ethicon, Inc.

Investigators

  • Principal Investigator: Ralph Austin, MS, FRCS, Colchester General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (ANTICIPATED)

March 1, 2014

Study Completion (ANTICIPATED)

March 1, 2014

Study Registration Dates

First Submitted

November 7, 2009

First Submitted That Met QC Criteria

November 9, 2009

First Posted (ESTIMATE)

November 10, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

February 5, 2014

Last Update Submitted That Met QC Criteria

February 4, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09/H0302/104

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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