Needlescopic Versus Transvaginal/Transumbilical Cholecystectomy (NATCH)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dirk R. Bulian, University of Witten/Herdecke
ClinicalTrials.gov Identifier:
NCT01685775
First received: September 4, 2012
Last updated: October 12, 2013
Last verified: October 2013
  Purpose

Laparoscopic surgery has become the golden standard for the removal of the gallbladder. Recently, developments have been made so that operations can be performed through a natural orifice instead of the abdominal wall, thus minimizing the trauma of a procedure. This study compares the transvaginal/transumbilical cholecystectomy with the laparoscopic operation using 2-3mm instruments in female patients. It also examines the benefits and disadvantages related to postoperative pain, cosmetic aspects, and potential physiological alterations to the transvaginal approach that affect sexual intercourse.


Condition Intervention
Calculus of Gallbladder With or Without Cholecystitis
Laparoscopic Cholecystectomy
Procedure: Transvaginal/transumbilical
Procedure: Needlescopic with 3 trocars

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Needlescopic Versus Transvaginal/Transumbilical Cholecystectomy: a Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by University of Witten/Herdecke:

Primary Outcome Measures:
  • Intensity of pain in motion [ Time Frame: at the operation day ] [ Designated as safety issue: No ]
    Pain Scores on the Visual Analog Scale (0-10)

  • Intensity of pain in motion [ Time Frame: at postoperative day 1 ] [ Designated as safety issue: No ]
    2 measures (in the morning and in the evening) Pain Scores on the Visual Analog Scale (0-10)

  • Intensity of pain in motion [ Time Frame: at postoperative day 2 ] [ Designated as safety issue: No ]
    Pain Scores on the Visual Analog Scale (0-10)


Secondary Outcome Measures:
  • Cosmetic aspects and overall satisfaction with the results of the surgery [ Time Frame: 10 days after operation ] [ Designated as safety issue: No ]
    1 (complete satisfaction) to 5 (complete dissatisfaction) scale from patient's and surgeon's point of view

  • Intraoperative complications [ Time Frame: evaluated at the operation day ] [ Designated as safety issue: Yes ]
    e.g. bleeding, organ-injury, especially bile-duct-injury

  • Duration of the operation [ Time Frame: at the operation day ] [ Designated as safety issue: No ]
    (in minutes)

  • Surgical handling for the first and second surgeon [ Time Frame: evaluated at the operation day ] [ Designated as safety issue: No ]
    on a 1 to 5 scale

  • Intensity of pain in motion [ Time Frame: at postoperative day 2 ] [ Designated as safety issue: No ]
    in the evening pain Scores on the Visual Analog Scale (0-10)

  • Cumulative use of analgesics [ Time Frame: 10 days after the surgery ] [ Designated as safety issue: No ]
    quantity, dose and class of the used drugs

  • Return to everyday, work related and free time activities [ Time Frame: 3 months after operation ] [ Designated as safety issue: No ]
    duration of limitations.

  • Quality of life [ Time Frame: on postoperative day 10 ] [ Designated as safety issue: No ]
    measured with the Gastrointestinal Quality of Life Index (GIQLI) from Eypasch et al.

  • Postoperative restrictions of sexual function [ Time Frame: 3 months after surgery ] [ Designated as safety issue: Yes ]
    with questions 14-19 of the "female sexual function index" (FSFI-D)

  • Morphological consequences of transvaginal access [ Time Frame: at the day before the operation, and again 10 to 14 days and 6 months after their surgery ] [ Designated as safety issue: Yes ]
    all patients from the transvaginal/transumbilical group will be examined by a gynaecologist

  • Cosmetic aspects and overall satisfaction with the results of the surgery [ Time Frame: 3 months after operation ] [ Designated as safety issue: No ]
    1 (complete satisfaction) to 5 (complete dissatisfaction) scale from patient's and surgeon's point of view

  • Cosmetic aspects and overall satisfaction with the results of the surgery [ Time Frame: 6 months after operation ] [ Designated as safety issue: No ]
    1 (complete satisfaction) to 5 (complete dissatisfaction) scale; from patient's and surgeon's point of view

  • Conversionrate [ Time Frame: at the operation day ] [ Designated as safety issue: No ]
    Conversion from transvaginal to classical laparoscopic or open technique and from needlescopic to open technique

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: at 6 month ] [ Designated as safety issue: Yes ]
    including frequency of reoperation

  • Intensity of pain in motion [ Time Frame: at postoperative day 3 ] [ Designated as safety issue: No ]
    in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)

  • Intensity of pain in motion [ Time Frame: at postoperative day 4 ] [ Designated as safety issue: No ]
    in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)

  • Intensity of pain in motion [ Time Frame: at postoperative day 5 ] [ Designated as safety issue: No ]
    in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)

  • Intensity of pain in motion [ Time Frame: at postoperative day 6 ] [ Designated as safety issue: No ]
    in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)

  • Intensity of pain in motion [ Time Frame: at postoperative day 7 ] [ Designated as safety issue: No ]
    in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)

  • Intensity of pain in motion [ Time Frame: at postoperative day 8 ] [ Designated as safety issue: No ]
    in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)

  • Intensity of pain in motion [ Time Frame: at postoperative day 9 ] [ Designated as safety issue: No ]
    in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)

  • Intensity of pain in motion [ Time Frame: at postoperative day 10 ] [ Designated as safety issue: No ]
    in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)


Enrollment: 40
Study Start Date: February 2010
Study Completion Date: December 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Transvaginal/transumbilical cholecystectomy
Transvaginal/transumbilical group: we will use a 5 mm trocar in the umbilicus and a 10 mm trocar together with a 5 mm seizing forceps through the posterior vaginal vault to perform the cholecystectomy in the Zornig style
Procedure: Transvaginal/transumbilical
Active Comparator: Needlescopic cholecystectomy
Needlescopic cholecystectomy with 3 trocars: we will use two 2-3 mm working trocars and one 10 mm optic trocar, its access is also used for extraction of the gallbladder
Procedure: Needlescopic with 3 trocars

Detailed Description:

The amount of trauma inflicted, especially in abdominal operations, depends largely on target organ access. Great efforts have been made to minimize access trauma. The further development of laparoscopy led to the miniaturization of surgical instruments and otherwise the use of natural orifices, like the stomach, rectum or vagina. The cholecystectomy is currently performed needlescopicly with 2-3 mm trocars and in transumbilically assisted transvaginal technique. The aim of this randomized study is to compare these two techniques in female patients that are in need of an elective cholecystectomy. The patients will be randomized on a 1:1 ratio into two treatment groups. In the needlescopic group the investigators will use two 2-3 mm working trocars and one 10 mm optic trocar, also to extract the gallbladder. In the transvaginal/transumbilical group the investigators will perform the Zornig technique using a 5 mm trocar in the umbilicus and a 10 mm trocar together with a 5 mm seizing forceps through the posterior vaginal vault. The primary endpoint of this trial is to measure the intensity of pain in motion measured from the day of the operation until postoperative day 2. Four different measurements of pain will be used. Furthermore the investigators examine perioperative complications as security parameters. The trial is supported in part by the German Ministry of Research and Education (CHIR-Net grant, BMBF No. 01-GH-0605).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Gender: Female
  • Minimum Age: 18 Years
  • Maximum Age: 80 Years
  • indication for elective cholecystectomy on account of symptomatic cholecystolithiasis
  • age >=18 years and <=80 years
  • legal competence

Exclusion Criteria:

  • Acute cholecystitis or locally complicated disease (gallbladder empyema, choledocholithiasis, pancreatitis, etc.)
  • liver cirrhosis (Child Pugh A, B, C)
  • severe comorbidity, class IV or V as defined by the American Society for Anesthesiologists (ASA)
  • intact hymen
  • acute vaginal infection
  • lacking visibility of the uterine orifice
  • endometriosis
  • malignoma
  • obesity with a Body Mass Index (BMI) > 40 kg/m2
  • chronic abuse of analgesics or alcohol
  • neuromuscular disease that could interfere treatment or measures of pain
  • history of major abdominal surgery with a high risk of intraperitoneal adhesions (minor operations such as an appendectomy, inguinal hernia repair, minor gynaecological surgery, etc. will not be considered exclusion criteria)
  • gravidity or breastfeeding
  • allergy against analgesics
  • patients who are dependent on or employed by the trial sponsor or physicians
  • institutionalisation for legal reasons
  • participation in other clinical studies that could interfere with the present trial
  • no written informed consent signed
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01685775

Locations
Germany
Department of Abdominal, Vascular and Transplant Surgery; Cologne-Merheim Medical Center
Cologne, Germany, 51109
Sponsors and Collaborators
University of Witten/Herdecke
Investigators
Principal Investigator: Dirk R. Bulian Witten/Herdecke University
  More Information

Additional Information:
Publications:
Responsible Party: Dirk R. Bulian, Principal Investigator, University of Witten/Herdecke
ClinicalTrials.gov Identifier: NCT01685775     History of Changes
Other Study ID Numbers: U1111-1114-7386, DRKS00000341
Study First Received: September 4, 2012
Last Updated: October 12, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by University of Witten/Herdecke:
Gallbladder
cholecystectomy
NOTES
natural orifice transluminal endoscopic surgery
gallstone

Additional relevant MeSH terms:
Calculi
Cholecystitis
Acalculous Cholecystitis
Cholelithiasis
Cholecystolithiasis
Gallstones
Pathological Conditions, Anatomical
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 28, 2014