Needlescopic Versus Transvaginal/Transumbilical Cholecystectomy (NATCH)

University of Witten/Herdecke

Status: Completed

Conditions: Laparoscopic Cholecystectomy; Calculus of Gallbladder With or Without Cholecystitis

Treatments: Procedure: Needlescopic with 3 trocars; Procedure: Transvaginal/transumbilical

Study type: Interventional

Funder types: Other

Identifiers

NCT01685775

U1111-1114-7386

DRKS00000341 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 40 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Transvaginal/transumbilical cholecystectomy

Experimental group

Description:

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

Treatment:

Procedure: Transvaginal/transumbilical

Needlescopic cholecystectomy

Active Comparator group

Description:

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

Treatment:

Procedure: Needlescopic with 3 trocars