WithdrawnNot Applicable

Hybrid Transvaginal-Transabdominal Endoscopic Surgery

Stopped: unable to recruit participants

United States0Started 2009-12

Plain-language summary

The is a pilot study to evaluate the safety and efficacy of hybrid transvaginal-transabdominal procedures. Diagnostic peritoneoscopy (visualizing the inside of the abdomen), appendectomy (removal of the appendix), and cholecystectomy (removal of the gallbladder) will be performed through a vaginal incision with an additional small incision in the umbilicus.

Who can participate

Age range

18 Years – 60 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: * Chronic or early appendicitis * Symptomatic gallstones * Suspicious abdominal mass/nodule * Female * Age 18-60 years * ASA Class I or II Exclusion Criteria: * Pregnant women * History of previous abdominal, pelvic, or vaginal surgery * History of previous abdominal or pelvic radiation therapy * History of fibroid uterus * History of endometriosis * History of large ovarian cyst * History of unexplained vaginal bleeding or dyspareunia

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.

What they're measuring

Technical success

Timeframe: intra-operative

Complication

Timeframe: 1 month

Trial details

NCT IDNCT01039129

SponsorSt. Luke's-Roosevelt Hospital Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-10

View on ClinicalTrials.gov More Gallstones trials