Needlescopic Versus Transvaginal/Transumbilical Cholecystectomy

Study Overview
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Brief Summary
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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
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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).

Official Title
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Needlescopic Versus Transvaginal/Transumbilical Cholecystectomy: a Randomized Clinical Trial

Conditions
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Calculus of Gallbladder With or Without Cholecystitis, Laparoscopic Cholecystectomy

Intervention / Treatment
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* Procedure: Transvaginal/transumbilical
* Procedure: Needlescopic with 3 trocars


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transvaginal/transumbilical cholecystectomy<br>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<br> <br> |
| Active Comparator: Needlescopic cholecystectomy<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of pain in motion | Pain Scores on the Visual Analog Scale (0-10) | 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) | at postoperative day 1 | 
| Intensity of pain in motion | Pain Scores on the Visual Analog Scale (0-10) | at postoperative day 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 10 days after operation | 
| Intraoperative complications | e.g. bleeding, organ-injury, especially bile-duct-injury | evaluated at the operation day | 
| Duration of the operation | (in minutes) | at the operation day | 
| Surgical handling for the first and second surgeon | on a 1 to 5 scale | evaluated at the operation day | 
| Intensity of pain in motion | in the evening pain Scores on the Visual Analog Scale (0-10) | at postoperative day 2 | 
| Cumulative use of analgesics | quantity, dose and class of the used drugs | 10 days after the surgery | 
| Return to everyday, work related and free time activities | duration of limitations. | 3 months after operation | 
| Quality of life | measured with the Gastrointestinal Quality of Life Index (GIQLI) from Eypasch et al. | on postoperative day 10 | 
| Postoperative restrictions of sexual function | with questions 14-19 of the female sexual function index (FSFI-D) | 3 months after surgery | 
| Morphological consequences of transvaginal access | all patients from the transvaginal/transumbilical group will be examined by a gynaecologist | 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 | 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 | 6 months after operation | 
| Conversionrate | Conversion from transvaginal to classical laparoscopic or open technique and from needlescopic to open technique | at the operation day | 
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | including frequency of reoperation | at 6 month | 
| Intensity of pain in motion | in the morning and in the evening pain Scores on the Visual Analog Scale (0-10) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | at postoperative day 10 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gallbladder, cholecystectomy, NOTES, natural orifice transluminal endoscopic surgery, gallstone