NATCH: Needlescopic Versus Transvaginal/Transumbilical Cholecystectomy

Sponsor

University of Witten/Herdecke (Other)

Overall Status

Completed

CT.gov ID

NCT01685775

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Calculus of Gallbladder With or Without Cholecystitis Laparoscopic Cholecystectomy	Procedure: Transvaginal/transumbilical Procedure: Needlescopic with 3 trocars	N/A

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Needlescopic Versus Transvaginal/Transumbilical Cholecystectomy: a Randomized Clinical Trial

Study Start Date :

Feb 1, 2010

Actual Primary Completion Date :

Jul 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Intensity of pain in motion [at the operation day]
Pain Scores on the Visual Analog Scale (0-10)
Intensity of pain in motion [at postoperative day 1]
2 measures (in the morning and in the evening) Pain Scores on the Visual Analog Scale (0-10)
Intensity of pain in motion [at postoperative day 2]
Pain Scores on the Visual Analog Scale (0-10)

Secondary Outcome Measures

Cosmetic aspects and overall satisfaction with the results of the surgery [10 days after operation]
1 (complete satisfaction) to 5 (complete dissatisfaction) scale from patient's and surgeon's point of view
Intraoperative complications [evaluated at the operation day]
e.g. bleeding, organ-injury, especially bile-duct-injury
Duration of the operation [at the operation day]
(in minutes)
Surgical handling for the first and second surgeon [evaluated at the operation day]
on a 1 to 5 scale
Intensity of pain in motion [at postoperative day 2]
in the evening pain Scores on the Visual Analog Scale (0-10)
Cumulative use of analgesics [10 days after the surgery]
quantity, dose and class of the used drugs
Return to everyday, work related and free time activities [3 months after operation]
duration of limitations.
Quality of life [on postoperative day 10]
measured with the Gastrointestinal Quality of Life Index (GIQLI) from Eypasch et al.
Postoperative restrictions of sexual function [3 months after surgery]
with questions 14-19 of the "female sexual function index" (FSFI-D)
Morphological consequences of transvaginal access [at the day before the operation, and again 10 to 14 days and 6 months after their surgery]
all patients from the transvaginal/transumbilical group will be examined by a gynaecologist
Cosmetic aspects and overall satisfaction with the results of the surgery [3 months after operation]
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 [6 months after operation]
1 (complete satisfaction) to 5 (complete dissatisfaction) scale; from patient's and surgeon's point of view
Conversionrate [at the operation day]
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 [at 6 month]
including frequency of reoperation
Intensity of pain in motion [at postoperative day 3]
in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)
Intensity of pain in motion [at postoperative day 4]
in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)
Intensity of pain in motion [at postoperative day 5]
in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)
Intensity of pain in motion [at postoperative day 6]
in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)
Intensity of pain in motion [at postoperative day 7]
in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)
Intensity of pain in motion [at postoperative day 8]
in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)
Intensity of pain in motion [at postoperative day 9]
in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)
Intensity of pain in motion [at postoperative day 10]
in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts 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