NOTES-Assisted Laparoscopic Cholecystectomy Surgery
Condition: Cholecystectomy, Laparoscopic; Endoscopy
Study type: Interventional

Summary: 
      Refinements in laparoscopic surgery, coupled with advancements in therapeutic flexible
      endoscopy, have set the stage for surgery to move to even less invasive techniques to treat
      conditions in the GI tract and peritoneal cavity. Natural orifice translumenal endoscopic
      surgery (NOTES) offers a means of reducing and ultimately eliminating the need for abdominal
      incisions to gain access to the peritoneal cavity. In NOTES, a flexible endoscope and
      accessory instruments are inserted through a natural body orifice and passed through the wall
      of an organ to reach the abdominal cavity. By reducing or eliminating the need for abdominal
      incisions, NOTES may provide a least invasive surgical option that can reduce pain, recovery
      time, complications, and systemic inflammatory response when compared to a laparoscopic
      surgical approach. In this study, we propose to use the NOTES technique to eliminate the need
      for a 1.5-2.5 cm umbilical incision.

      Hypothesis 1: We hypothesize that a combined endoscopic and laparoscopic approach will be
      able to eliminate a 1.5 to 2.5 cm infraumbilical incision when performing a laparoscopic
      cholecystectomy.

      Hypothesis 2: Closure of the gastrotomy will be facilitated with the Ethicon TAS system.
    

Detailed description: 
      In this study, we propose to use a surgical technique that eliminates the need for a 1.5-2.5
      cm umbilical incision. All patients will receive pre-operative antibiotics. A Veress needle
      will be used to create pneumoperitoneum with insufflation of carbon dioxide gas by a standard
      laparoscopic insufflator. A 5 mm laparoscopic port will be inserted through the abdominal
      wall in the right mid-abdomen and a 5 mm laparoscope inserted for viewing the abdominal
      cavity. A flexible endoscope, positioned within a multi-lumen 18 mm therapeutic access
      device, will be inserted through the mouth and into the stomach. Using commercially available
      endoscopes, endoscopic instruments and accessories, a small incision will be made in the
      gastric wall and the endoscope will be advanced into the insufflated peritoneal cavity.
      Additional laparoscopic trocars may be placed through the abdominal wall for laparoscopic
      instrument insertion to manipulate, retract and cut tissue. The flexible endoscope will
      provide visualization of the surgical field and flexible endoscopic instruments may be used
      to augment surgical manipulation with the laparoscopic instruments. Intraoperative
      cholangiogram or laparoscopic ultrasound will be performed at the discretion of the surgeon.
      Once dissected free, the gallbladder will be removed through the stomach and out of the mouth
      with the aid of an endoscopic retrieval bag. Commercially available endoscopic clips, or FDA
      approved tissue anchors will be used to close the gastrotomy. Additionally, the gastrotomy
      closure will be tested for leaks and laparoscopically oversewn with suture.

      Operative and recovery room times as well as hospital length of stay will be collected.
      During the hospital stay, severity of pain, use of pain medications and complications will be
      recorded. Patients will be discharged per the standard of practice for a laparoscopic
      cholecystectomy. All study patients will receive a call from a surgery clinic nurse on
      post-op day 2 and 7. We will develop a check list that will contain the following (yes/no)
      elements to be used prior to discharge, on the post-op day 2 and 7 phone calls, and the 2
      week post-op clinic visit: pain controlled with meds, nausea, emesis, fever, chills, redness
      of incisions, drainage from incisions, shortness of breath, chest pain, yellow eyes, dark
      urine, clay-colored stools. If there are any "yes" responses to this checklist prior to
      discharge, the patient will not be discharged from the hospital. If there are any "yes"
      responses to this checklist at the post-op day 2 or 7 phone call, the patient will be advised
      to immediately come to the GI surgery clinic or go to the nearest emergency room. If there
      are any "yes" responses to this checklist at the 2 week clinic visit, the patient will
      undergo the necessary standard of care medical evaluation (labs, tests, etc.) and may be
      admitted to the hospital. These checklists will be reviewed by one of the investigators,
      collected and stored in a locked file cabinet.

      Patients will return and be evaluated by their surgeon two weeks following their procedure.
      At this visit, any post-operative complications will be noted in the patient's medical
      record. Additionally at this visit and at the preoperative visit, patients will complete a
      standardized Quality of Life (QOL) assessment (i.e., SF-36). Perceived pain levels and type
      and frequency of pain medications will be recorded in the patient's medical record.

      The potential advantages to the patients entered into this study include those mentioned
      above regarding elimination of post-operative wound infection and hernia but also the lack of
      abdominal incisions greater than 5 mm in length may reduce pain and recovery time and likely
      have a cosmetic advantage as well. Potential risks of this study involve the risks of the
      standard laparoscopic procedure including bleeding, infection, injury to surrounding
      structures and port/trocar site pain. Potential risks associated with use of flexible
      endoscopic instruments include esophageal perforation, bleeding and sore throat. In addition,
      there is the possibility that there may be new, unanticipated complications from this
      modified surgical technique. Patient risks will be mitigated by having the procedure
      performed by a surgeon with expertise in both laparoscopic surgery and flexible endoscopy, as
      well as having involvement of a skilled interventional gastroenterologist if deemed
      necessary.

      This feasibility study will initially evaluate the potential benefit, risks and impact on the
      patient's quality of life of this modified surgical technique in 10 patients. Once a
      standardized technique is established and risks are shown to be low, a prospective
      comparative evaluation is planned to compare this modified technique to the standard
      laparoscopic approach.
    

Intervention name(s): Endoscopically assisted Laparoscopic Cholecystectomy Surgery
Intervention type(s): Procedure
Intervention description(s): Using endoscopic instruments a small incision will be made in the gastric wall and the endoscope will be advanced into the insufflated peritoneal cavity. At least one laparoscopic trocars will be placed through the abdominal wall for laparoscopic instrument insertion to manipulate and cut tissue. The flexible endoscope will provide visualization of the surgical field and flexible endoscopic instruments may be used to augment surgical manipulation with the laparoscopic instruments. The gallbladder will be removed through the stomach and out of the mouth. Endoscopic clips, sutures or tissue anchors (TAS)will be used to close the gastrotomy.
Other intervention name(s): NOTES; Natural orifice translumenal endoscopic surgery; Transgastric Cholecystectomy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment