Calculus of Gallbladder With or Without Cholecystitis, Laparoscopic Cholecystectomy
Conditions
Keywords
Gallbladder, cholecystectomy, NOTES, natural orifice transluminal endoscopic surgery, gallstone
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.
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).
Interventions
PROCEDURETransvaginal/transumbilical
PROCEDURENeedlescopic with 3 trocars
Sponsors
University of Witten/Herdecke
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intensity of pain in motion | at the operation day | Pain Scores on the Visual Analog Scale (0-10) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Return to everyday, work related and free time activities | 3 months after operation | duration of limitations. |
Countries
Germany
Outcome results
None listed