Transvaginal Cholecystectomy Using Endoscopic Assistance

Learn more about:
Related Clinical Trial
Feasibility and Utility of Artificial Intelligence (AI) / Machine Learning (ML) – Driven Advanced Intraoperative Visualization and Identification of Critical Anatomic Structures and Procedural Phases in Laparoscopic Cholecystectomy Subserosal Laparoscopic Cholecystectomy Influence of Gut Microbiome in Gallstone Disease Erector Spinae Plane Block as a Rescue Pain Therapy in Patients Undergoing Laparoscopic Cholecystectomy Elective Endoscopic Gallbladder Treatment: Pilot Study Use of Indocyanine Green in Acute Cholecystitis Endosonography-guided Gallbladder Drainage vs Non-endoscopic Treatment in Inoperable Acute Cholecystitis Diagnostic Performance of Low-Dose CT for Acute Abdominal Conditions Factors Affecting The Recurrence Of Acute Cholecystitis After Treatment With Percutaneous Cholecystostomy M-Tapa Block vs External Oblique Intercostal Block for Laparoscopic Cholesistectomy Emergency Versus Elective Cholecystectomy in Acute Cholecystitis in the Era of Laparoscopy. Norwegian Randomized Trial on Indocyanine Green Cholangiography Utility for Laparoscopic Cholecystectomy, Prestudy A Phase 2 Study Evaluating Efficacy, Safety and Tolerability of Different Doses and Regimens of Allocetra-OTS for the Treatment of Organ Failure in Adult Sepsis Patients Effect Of Early Versus Delayed Laparoscopic Cholecystectomy In Patients With Grade II Cholecystitis Effectiveness of Empirical Antibiotic Use in Mild to Moderate Acute Inflammatory Gallbladder Disease ENDOSCOPIC ULTRASONOGRAPHY (EUS) GUIDED GALLBLADDER DRAINAGE WITH TWO MONTHS STENT REMOVAL FOR ACUTE CHOLECYSTITIS: A PROSPECTIVE STUDY The Efficacy and Safety of Using Prophylactic Abdominal Drainage After Cholecystectomy M-Tapa Block for Laparoscopic Cholesistectomy The Comparison of Hemodynamic Effects Between Remimazolam-remifentanil and Propofol-remifentanil in Patients Undergoing Laparoscopic Cholecystectomy Impact of Percutaneous Cholecystostomy in the Management of Acute Cholecystitis. Indocyanine Green Fluorescent Cholangiography and Intraoperative Angiography With Laparoscopic Cholecystectomy Fetal Outcomes Among Pregnant Emergency General Surgery Patients Usefulness of the CADISS® System for the Cleavage of Severe Adhesions in Cholecystectomy SPY Fluorescence Imaging Systems and Indocyanine Green as a Tool for Developing Intelligent Peri-Operative Imaging Early Laparoscopic Cholecystectomy Versus Percutaneous Cholecystostomy in Grade II Acute Cholecystitis Guidelines Validation and Comparison of Scores for Prediction of RIsk for Post-operative Major Morbidity After Cholecystectomy in Acute Calculous Cholecystitis (SPRIMACC) GB34 Acupuncture in Acute Cholecystitis Low Dose ICG for Biliary Tract and Tumor Imaging Visualization of the Extrahepatic biliaRy Tree Trial Gallbladder Cryoablation in High-Risk Patients Hong Kong Follow up Protocol After EUS Gallbladder Drainage for Acute Cholecistitis Bikini Scarless Laparoscopic Cholecystectomy for Morbid Obesity as a Day Case. Naldebain for Pain Management of Laparoscopic Cholecystectomy Operative vs Non-Operative Management of Acute Appendicitis and Acute Cholecystitis in COVID-19 Positive Patients Acute Cholecystitis With Concomitant Choledocholithiasis: Unicentric Study of Prevalence and Predictive Factors Effectiveness of Prophylactic Antibiotics Therapy in Laparoscopic Cholecystectomy on Infection Rate Necessity of Preoperative Empirical Antibiotic Use in Acute Cholecystitis Safety and Feasibility of ActivSightTM in Human Indocyanine Green to Visualize Critical View of Safety During Laparoscopic Cholecystectomy for Acute Cholecystitis US-guided Trocar Versus Seldiger Technique for Percutaneous Cholecystostomy Laparoscopic Cholecystectomy for Acute Calculous Cholecystitis in the Elderly: A Retrospective Study. A Scoring System for Difficult Laparoscopic Cholecystectomy RISK FACTORS FOR NECROTIC CHOLECYSTITIS DURING COVID-19 PANDEMIC: THE ChoCO WSES PROSPECTIVE MULTICENTER OBSERVATIONAL STUDY Evaluation of a Protocol for Multidisciplinary Management of Acute Cholecystitis. How to Predict Postoperative Complications After Early Laparoscopic Cholecystectomy for Acute Cholecystitis: the Chole-Risk Score Ondansetron Effect on Pain Relief After Laparoscopic Cholecystectomy Different Timing for Early Laparoscopic Cholecystectomy in Acute Calcular Cholecystitis Prognostic Indicators as Provided by the EPIC ClearView WSES International Register of Emergency Surgery Evaluation of Implementation of a National Point-of-Care Ultrasound Training Program Deep Versus Moderate Neuromuscular Blockade During Laparoscopic Surgery Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection (cIAI) Cefoperazone/Sulbactam In The Treatment Of Serious Intra-Abdominal And Hepatobiliary Infections. Prospective Validation of “Cholecystectomy First” Strategy for Gallstone Migration ONSD According to the Position During Laparoscopy Risk of Umbilical Trocar-site Hernia After SILC Cholecystectomy Versus Conventional Cholecystectomy Drainage or Not for Laparoscopic Cholecystetomy UDCA for Symptomatic Gallstone Disease Small-incision Open Cholecystectomy or Laparoscopic Cholecystectomy for Gallbladder Disease Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection Transvaginal Cholecystectomy Using Endoscopic Assistance Doripenem in the Treatment of Complicated Intra-Abdominal Infections Doripenem in the Treatment of Complicated Intra-Abdominal Infections The Use of Fluorescent Imaging for Intraoperative Cholangiogram During Laparoscopic Cholecystectomy No Need for Neuromuscular Blockade in Daycase Laparoscopic Surgery Efficacy of Proficiency-based Versus Free Laparoscopic Training in Cholecystectomy on a Virtual Reality Simulator Single Port Access (SPA) Cholecystectomy Versus Standard Laparoscopic Cholecystectomy Single-Incision Laparoscopic Cholecystectomy Versus Traditional Laparoscopic Cholecystectomy Evaluation of PC 6 “Neiguan” With Conventional Acupuncture to Prevent PONV After Laparoscopic Cholecystectomy. Role of the Right Portal Pedicle and Rouviere’s Sulcus as an Anatomic Landmark in Laparoscopic Cholecystectomy DGT Versus TPS in Patients With Initial PD Cannulation by Chance; Prospective Multi-center Study Laparoscopic Transvaginal Hybrid Cholecystectomy: a Prospective Data Collection. NOTES-Assisted Laparoscopic Cholecystectomy Surgery EUS-guided Transenteric Drainage With a Novel Lumen-apposing Metal Stent Effect of Vitamin C on Postoperative Pain After Laparoscopic Cholecystectomy NOVOsyn® for Trocar Incision After Laparoscopic Appendectomy and Cholecystectomy Fluorescence Cholangiography During Cholecystectomy – a RCT Outcome of IV Acetaminophen Use in Laparoscopic Cholecystectomies in Patients at Risk of OSA FALCON: a Multicenter Randomized Controlled Trial Cholecystectomy First vs Sequential Common Bile Duct Imaging + Cholecystectomy Initial Experience With a New Laparoscopic Based Robotically Assisted Surgical System for Cholecystectomy Spinal Versus General Anesthesia for Laparoscopic Cholecystectomy 3D Versus 4K Laparoscopic Cholecystectomy Laryngeal Mask Airway Supreme Versus the Tracheal Tube as an Airway Device in Elective Laparoscopic Cholecystectomy Effect of Modified Stylet Angulation on the Intubation With GlideScope® Evaluation of Closed-loop TIVA Propofol, Sufentanil and Ketamine Guided by BIS Monitor BDD With UDCA Therapy After Laparoscopic Cholecystectomy Transmuscular Quadratus Lumborum Block for Laparoscopic Cholecystectomy Postoperative Pain Results According to Pressure to Form Pneumoperitoneum Benefits of Glycopyrrolate on Intubation With Rigid-videostylet (OptiScope®) Prediction of Postoperative Pain by Injection Pain of Propofol Transient ECG Changes in Patients With Acute Biliary Disease Randomized Control Trial of Intraperitoneal Bupivacaine During Cholecystectomy Establishing Visualization Grading Scale on LESS Cholecystectomy Improving Informed Consent Process for Percutaneous Cholecystostomy in the Emergency Department Natural Orifice Transgastric Endoscopic Surgical Removal of the Gallbladder Anesthesia With Propofol, Dexmedetomidine and Lidocaine Infusions for Laparoscopic Cholecystectomy A Clinical Study of Chinese Domestic Surgical Robot Laparoscopic Cholecystectomy: Study of Left Side of Laparoscopic Cholecystectomy Tracheal Intubation in Patient With Semi-rigid Collar Immobilization of the Cervical Spine: A Comparison of Fiberoptic Bronchoscope Assisted With Pentax-airway Scope and Fiberoptic Bronchoscope Alone Effect of Intraoperative Nefopam on Acute Pain After Remifentanil Based Anesthesia Ultrasound Guided Subcostal Transversus Abdominis Plane Versus Paravertebral Block in the Laparoscopic Cholecystectomy Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy Effects of Drainage in Laparoscopic Cholecystectomy Observation vs Early Removal of LAMS in EUS Guided Cholecystoenterostomy Study of Pain Perception Between Males and Females Following Laparoscopic Cholecystectomy Drainage is Not Necessary Procedure After Laparoscopic Cholecystectomy Due to Severe Acute Cholecystitis Comparison of Morbidity After Laparoscopic Cholecystectomy for Acutely Inflamed Gall Bladder With and Without Drain Early Versus Delayed Cholecystectomy If Chronic Gallbladder Diseases Increase the Incidence of PEC Remote Ischemic Preconditioning in Patients Undergoing Acute Minor Abdominal Surgery Use of Robotics for Cholecystectomy; Retrospective Review of Outcomes, Set Up and Learning Curves Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy — Use in Acute Cholecystitis Sub-Study The Relationship Between Post-ERCP-choledocholithiasis and Gallbladder Status Endoscopic Nasogallbladder Drainage Versus Gallbladder Stenting Before Cholecystecomy Enhanced Recovery in Laparoscopic Cholecystectomy Empirical Antibiotics in Acute Inflammatory Gallbladder Disease Primary EUS-GBD in Patients With Unresectable Malignant Biliary Obstruction and Cystic Duct Orifice Involvement. Laparoscopic Cholecystectomy for Acute Cholecystitis After 72 Hours of Symptoms Bile Aspiration vs Drain in Acute Cholecystitis Interest of Intravenous Cholangiography With Indocyanine Green in the Context of Laparoscopic Cholecystectomy for Grade 1 and 2 Acute Gallstone Cholecystitis Fluorescent Cholangiography During Acute Cholecystitis Reduction of Operating Time by a Smoke Electroprecipitation Device for Acute Cholecystitis Piperacllin Versus Placebo in Patients Undergoing Surgery for Acute Cholecystitis Ultrasonically Activated Scalpel Versus Electrocautery Based Dissection in Acute Cholecystitis Trial Is it Fair to Use Antibiotics After Laparoscopic Cholecystectomy for the Patients With Acutely Inflamed Gallbladder? Percutaneous Transhepatic Cholangiography (PTHC) in Acute Cholecystitis and Clinical Outcomes Acute Cholecystitis – Early Laparoscopic Surgery Versus Antibiotic Therapy and Delayed Elective Cholecystectomy Scoring System in Acute Calculous Cholecystitis Is it Safe to do Laparoscopic Cholecystectomy for Acute Cholecystitis up to Seven Days? Fast Track Pathway to Accelerated Cholecystectomy Laparoscopic Cholecystectomy or Conservative Treatment in the Acute Cholecystitis of Elderly Patients Efficacy and Safety of Floseal for the Haemostasis During Laparoscopic Cholecystectomy in Acute Cholecystitis (GLA) Acute Cholecystitis: Early Versus Delayed Laparoscopic Cholecystectomy; Randomized Prospective Study Short Term Outcomes of Acute Cholecystitis Managed at a University Hospital Harmonic in Laparoscopic Cholecystectomy for Acute Cholecystitis EUS-guided Gallbladder Drainage Instead of Laparoscopic Cholecystectomy for Acute Cholecystitis. A Feasibility Study. Prospective Trial for Endoscopic Ultrasound Guided Gallbladder Drainage for Acute Cholecystitis in High Risk Patients A Randomized Controlled Trial on EGBD vs PC for Acute Cholecystitis. Magnetic Resonance Cholangiography and Intraoperative Cholangiography in Acute Cholecystitis The Role of Ultrasound in Cholecystitis AXIOS™ for Gallbladder Drainage as an Alternative to Percutaneous Drainage IDE Extended Antibiotic Therapy in Postoperative of Laparoscopic Cholecystectomy in Acute Cholecystitis The Real World of Acute Cholecystitis Functional MRC With Eovist for Acute Cholecystitis FDG-PET/CT in the Evaluation of Patients With Suspected Cholecystitis

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