Needlescopic Versus Transvaginal/Transumbilical Cholecystectomy (NCT01685775) | Clinical Trial Compass
CompletedNot Applicable
Needlescopic Versus Transvaginal/Transumbilical Cholecystectomy
Germany40 participantsStarted 2010-02
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.