Trial document



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  DRKS00000341

Trial Description

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Title

Needlescopic versus transvaginal/transumbilical cholecystectomy: a randomized clinical trial

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Trial Acronym

NATCH

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URL of the Trial

[---]*

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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 we will use two 2-3 mm working trocars and one 10 mm optic trocar, also to extract the gallbladder. In the transvaginal/transumbilical group we 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 we 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).

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Organizational Data

  •   DRKS00000341
  •   2010/02/24
  •   [---]*
  •   yes
  •   Approved
  •   89/2009, Ethik-Kommission der Universität Witten/Herdecke
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Secondary IDs

  •   U1111-1114-7386 
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Health Condition or Problem studied

  •   K80.20 -  [generalization K80.2: Calculus of gallbladder without cholecystitis]
  •   K80.10 -  [generalization K80.1: Calculus of gallbladder with other cholecystitis]
  •   5-511.11: Laparoscopic cholecystectomy
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Interventions/Observational Groups

  •   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.
  •   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.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
  •   [---]*
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Primary Outcome

Intensity of pain in motion measured from operation day to postoperative day 2. This outcome includes a total of 4 measurements.

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Secondary Outcome

Cosmetic aspects and overall satisfaction with the results of the surgery: 1 (complete satisfaction) to 5 (complete dissatisfaction) scale. || Intraoperative complications, undesirable events, conversions. || Duration of the operation (in minutes). || Surgical handling for the first and second surgeon on a 1 to 5 scale. || Intensity of pain in motion measured from postoperative day 2 to 10. This outcome includes a total of 17 measurements. || Use of analgesics: quantity, dose and class of the used drugs between the operative day and postoperative day 10. || Postoperative complications including frequency of reoperation. || Return to everyday, work related and free time activities: duration of limitations. || Quality of life measured on postoperative day 10 with the Gastrointestinal Quality of Life Index (GIQLI) from Eypasch et al. || Postoperative restrictions of sexual function: to be measured 3 months after surgery with part of the "female sexual function index" (FSFI-D). || Morphological consequences of transvaginal access: all patients from the transvaginal/transumbilical group will be examined by a gynaecologist before their operation, and again 10 to 14 days and 6 months after their surgery.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   2010/02/19
  •   Actual
  •   40
  •   [---]*
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

Female gender; indication for elective cholecystectomy on account of symptomatic cholecystolithiasis; age >=18 years and <=80 years; legal competence.

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Exclusion Criteria

Acute cholecystitis or locally complicated disease (gallbladder empyema, choledocholithisis, 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 analagesics 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.

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Addresses

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    • Klinik für Viszeral-, Gefäß- und Transplantationschirurgie Lehrstuhl Chirurgie I Universitätsklinikum Witten/Herdecke mit Sitz in Köln Krankenhaus Merheim
    • Ostmerheimerstr. 200
    • 51109  Köln
    • Germany
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    • Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG)
    • Mr.  Dr. med.  Stefan  Sauerland 
    • Dillenburger Straße 27
    • 51105  Köln
    • Germany
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    • Klinik für Viszeral-, Gefäß- und Transplantationschirurgie Lehrstuhl Chirurgie I Universitätsklinikum Witten/Herdecke mit Sitz in Köln Krankenhaus Merheim
    • Mr.  Dr. med.  Dirk R.  Bulian 
    • Ostmerheimerstr. 200
    • 51109  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Viszeral-, Gefäß- und Transplantationschirurgie Lehrstuhl Chirurgie I Universitätsklinikum Witten/Herdecke mit Sitz in Köln Krankenhaus Merheim
    • Ostmerheimerstr. 200
    • 51109  Köln
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.