Transvaginal Cholecystectomy Using Endoscopic Assistance

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Brief Title

Transvaginal Cholecystectomy Using Endoscopic Assistance

Official Title

Laparoscopic Cholecystectomy Using Transvaginal Endoscopic Assistance

Brief Summary

      Surgical removal of the gallbladder is needed in 1 million people per year in the USA. The
      procedure is done by placing four tubes (cannula) from 5 to 10 mm through the abdominal wall.
      Air is placed in the abdominal cavity and a lighted scope is placed through one cannula. The
      space in the abdominal cavity can then be seen on a video screen. Thin retractors and
      dissecting instruments are placed through the other cannula and the gallbladder is removed
      using the video screen for vision. The gallbladder duct and the artery are usually occluded
      with clips or stitches.

      In this study we propose to do the procedure though a single 5 mm incision placed at the
      umbilicus and a second access through the vagina using a flexible endoscope. The gallbladder
      will be retracted using strings (sutures) attached to the gallbladder. The dissection will be
      done using laparoscopic instruments (scissors, knives, dissectors) placed through the
      laparoscopic port. A flexible grasper may be used in the endoscope to help with retraction.
      An endoscopic snare or grasper will be used to grasp the gallbladder and remove it from the
      abdomen through the vagina.

      This study evaluates the ability to do laparoscopic cholecystectomy with one skin incision
      and one vaginal incision. This will provide the basis for future studies evaluating decreased
      pain and costs with transvaginal assisted cholecystectomy.
    

Detailed Description

      BACKGROUND When doing laparoscopic cholecystectomy, there are generally four ports placed
      through four separate skin incisions. One port is used for a rigid laparoscope, two for
      retraction, and one for dissecting. We have recently started to reduce the number of
      incisions for laparoscopic cholecystectomy to one umbilical incision. Three ports are used
      through one incision by suspending the gallbladder to the abdominal wall using sutures. This
      allows the surgeon to eliminate incisions and the patients have reduced postoperative wound
      pain and improved cosmesis. However, by using standard laparoscopic rigid instruments and
      optic systems it is challenging to perform this operation via a single incision.

      Recently, natural orifice transluminal endoscopic surgery (NOTES) has been used in females to
      reduce the size and number of fascial incisions of the anterior abdominal wall. This vaginal
      approach has generally been done with the aid of laparoscopy (hybrid procedure). The vaginal
      assistance may allow small abdominal wall incisions resulting in less pain and faster
      recovery than after the standard laparoscopic approach.

      We propose a phase I study of a laparoscopic cholecystectomy using a single 5 mm port and
      transvaginal endoscopic assistance in 10 female patients. The procedure will have at least
      one 5 mm laparoscopic port for safety and assistance. Conversions to conventional
      laparoscopic surgery will be done if difficulties are encountered.

      OBJECTIVE Reduction in the number of ports required in laparoscopic cholecystectomy.

      Null hypothesis: Laparoscopic cholecystectomy requires two or more fascial port sites to
      perform.

      Alternative hypothesis: Laparoscopic cholecystectomy can be done with a single 5 mm
      laparoscopic port with transvaginal assistance of flexible endoscopy.

      The standard laparoscopic procedure will be used as the control.

      STUDY DESIGN This study will be conducted as a prospective, single site, non-randomized,
      single-arm study among elective surgery patients. Subjects will be enrolled from a population
      of otherwise healthy females undergoing laparoscopic surgery for cholelithiasis,
      cholecystitis, or biliary dyskinesia. Patients enrolled in the study will have a flexible
      transvaginal endoscopy used during laparoscopic cholecystectomy. Subjects enrolled will be
      told that the primary purpose of the study is to try to reduce the number of laparoscopic
      ports and skin incisions that are necessary to perform their cholecystectomy. Subjects will
      be followed for approximately 6 weeks post treatment for purposes of the study.

      STUDY PROCEDURE At surgery, the patient will be placed in the dorsal lithotomy position.
      Sterile prep and drape of the anterior abdominal wall, perineum, and vagina will be
      obtained.. A 7-8 mm umbilical skin incision will be made. Using standard techniques, a Veress
      insufflation needle will be placed at the umbilicus to establish pneumoperitoneum. A 5 mm
      laparoscopic port will then be placed at the umbilicus. Pressure will be set from 6 to 15 mm
      of mercury to obtain an adequate working space.

      Patients will then undergo a pelvic exam by a gynecologist followed by placement of a
      weighted speculum into the vagina. Forceps or tenaculum will then be used to grasp the
      posterior lip of the cervix and the cervico-vaginal junction identified. A uterine
      manipulator will be placed into the uterus to allow manipulation of the uterus. A 10 mm
      incision will be made though the posterior vaginal wall 1 cm from the cervix. The patient
      will then be placed into deep Trendelenburg positioning. A 10mm trocar will be placed against
      the posterior vaginal fornix creating a point of pressure on the pelvic peritoneum visible by
      laparoscopy. This point will be in the midline of posterior fornix between the utero-sacral
      ligaments. The weighted speculum will be removed and gently steady pressure will be applied
      to the vaginal trocar until entry into the posterior cul-de-sac is directly visualized by the
      laparoscope. Alternatively, the colpotomy will be performed without using a trocar, under
      direct vision. One of two Olympus flexible scopes will be used. An 8.7 mm sterile Olympus
      flexible single channel gastroscope can be placed though the vaginal port. A 2 channel scope
      requires removal ofthe10 mm vaginal port and placement of the 2 channel scope over a wire.
      All scope insertions will be observed under laparoscopy for safety.

      The gallbladder will then have 1-4 sutures or endoloops attached to the gallbladder and
      placed through the anterior abdominal wall using a 1 mm suture passer (GraNee). Dissection
      will be done around the cystic duct using commercially available laparoscopic dissectors. For
      dissection of the gallbladder and cystic duct/artery, the flexible instruments will be used
      via the endoscope as alternative to laparoscopic instruments where appropriate. The cystic
      duct will be clipped with laparoscopic clips and divided. The cystic artery will be dissected
      clipped and divided in a similar fashion. The gallbladder will then be dissected from the
      gallbladder bed.

      If indicated by the surgeon to facilitate or complete the procedure, laparoscopic ports will
      be added through additional abdominal wall incision sites. Laparoscopic instruments will
      assist in the procedure as needed by the judgment of the surgeon. The addition of
      laparoscopic ports and/or instruments will be documented. Rarely the gallbladder cannot be
      removed in a laparoscopic fashion and must be removed in an open manner. This same risk is
      present for any laparoscopic cholecystectomy.

      Once the gallbladder is detached, the traction sutures will be cut. An endoscopic snare or
      grasper will be used to grasp the gallbladder and remove it from the abdomen through the
      vagina. Should an endocatch bag be needed to extract the gallbladder, it will be placed via
      the vaginal port and visualized by laparoscopy. The gallbladder bed will be inspected and
      irrigated. The skin is closed in a subcuticular manner. The laparoscopic fascial port will
      not be closed which is standard for 5 mm ports. The posterior vagina will be closed with a
      running absorbable suture. The pelvic peritoneum will not be closed which is standard in many
      pelvic operations. Post operative care with be identical to laparoscopic cholecystectomy.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Reduction in the number of laparoscopic ports

Secondary Outcome

 Cost analysis comparison of surgical procedures.

Condition

Cholelithiasis

Intervention

cholecystectomy.

Study Arms / Comparison Groups

 Surgical Procedure
Description:  Laparoscopic transvaginal cholecystectomy with endoscopic assistance.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

0

Start Date

January 2009

Completion Date

May 2011

Primary Completion Date

May 2011

Eligibility Criteria

        Inclusion Criteria:

          -  Female age ≥ 18 yrs

          -  Diagnosis of cholelithiasis, cholecystectomy, choledocholithiasis or biliary
             dyskinesia and scheduled for laparoscopic cholecystectomy

          -  Have an indication for a standard laparoscopic procedure cholecystectomy

          -  Not pregnant

        Exclusion Criteria:

          -  Any significant co-morbidities, including significant cardiac disease, history of
             stroke, severe pulmonary disease, hypertension with a diastolic greater than 100,
             pancreatitis.

          -  Patients that are immunosuppressed or on immunosuppression therapy.

          -  An unacceptable psychological or medical risk as determined by the primary
             investigators.
      

Gender

Female

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Brent Miedema, MD, , 



Administrative Informations


NCT ID

NCT00815438

Organization ID

1125518


Responsible Party

Sponsor

Study Sponsor

University of Missouri-Columbia


Study Sponsor

Brent Miedema, MD, Principal Investigator, University of Missouri-Columbia


Verification Date

September 2016