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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Department of Abdominal, Vascular and Transplant Surgery; Cologne-Merheim Medical Center
Cologne, Germany
Intensity of pain in motion
Pain Scores on the Visual Analog Scale (0-10)
Time frame: at the operation day
Intensity of pain in motion
2 measures (in the morning and in the evening) Pain Scores on the Visual Analog Scale (0-10)
Time frame: at postoperative day 1
Intensity of pain in motion
Pain Scores on the Visual Analog Scale (0-10)
Time frame: at postoperative day 2
Cosmetic aspects and overall satisfaction with the results of the surgery
1 (complete satisfaction) to 5 (complete dissatisfaction) scale from patient's and surgeon's point of view
Time frame: 10 days after operation
Intraoperative complications
e.g. bleeding, organ-injury, especially bile-duct-injury
Time frame: evaluated at the operation day
Duration of the operation
(in minutes)
Time frame: at the operation day
Surgical handling for the first and second surgeon
on a 1 to 5 scale
Time frame: evaluated at the operation day
Intensity of pain in motion
in the evening pain Scores on the Visual Analog Scale (0-10)
Time frame: at postoperative day 2
Cumulative use of analgesics
quantity, dose and class of the used drugs
Time frame: 10 days after the surgery
Return to everyday, work related and free time activities
duration of limitations.
Time frame: 3 months after operation
Quality of life
measured with the Gastrointestinal Quality of Life Index (GIQLI) from Eypasch et al.
Time frame: on postoperative day 10
Postoperative restrictions of sexual function
with questions 14-19 of the "female sexual function index" (FSFI-D)
Time frame: 3 months after surgery
Morphological consequences of transvaginal access
all patients from the transvaginal/transumbilical group will be examined by a gynaecologist
Time frame: at the day before the operation, and again 10 to 14 days and 6 months after their surgery
Cosmetic aspects and overall satisfaction with the results of the surgery
1 (complete satisfaction) to 5 (complete dissatisfaction) scale from patient's and surgeon's point of view
Time frame: 3 months after operation
Cosmetic aspects and overall satisfaction with the results of the surgery
1 (complete satisfaction) to 5 (complete dissatisfaction) scale; from patient's and surgeon's point of view
Time frame: 6 months after operation
Conversionrate
Conversion from transvaginal to classical laparoscopic or open technique and from needlescopic to open technique
Time frame: at the operation day
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
including frequency of reoperation
Time frame: at 6 month
Intensity of pain in motion
in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)
Time frame: at postoperative day 3
Intensity of pain in motion
in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)
Time frame: at postoperative day 4
Intensity of pain in motion
in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)
Time frame: at postoperative day 5
Intensity of pain in motion
in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)
Time frame: at postoperative day 6
Intensity of pain in motion
in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)
Time frame: at postoperative day 7
Intensity of pain in motion
in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)
Time frame: at postoperative day 8
Intensity of pain in motion
in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)
Time frame: at postoperative day 9
Intensity of pain in motion
in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)
Time frame: at postoperative day 10
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