CompletedNot Applicable

Laparoscopic Transvaginal Hybrid Anterior Resection: a Prospective Data Collection

Switzerland45 participantsStarted 2008-09

Plain-language summary

Transvaginal hybrid procedures are of interest as an available NOTES-Procedure for the clinical routine. Few authors have demonstrated the feasibility and safety of such procedures (e.g. cholecystectomy) in selected patient collectives. In 2008 Lacy at al. published the experience with a transvaginal sigmoidectomy as a first in human report. The aim of this prospective data collection is to evaluate the feasibility and safety of the transvaginal hybrid anterior resection in the clinical routine. Therefore all patients giving the informed consent to the transvaginal hybrid anterior resection will be included and assessed concerning feasibility to perform the transvaginal approach and complete the operation transvaginally.

Who can participate

Age range

18 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: * given informed consent * sigmoid diverticulosis (two or more attacks) * sigmoid diverticulitis (Hinchey I and II) Exclusion Criteria: * ASA IV * emergency surgery * liver-malfunction or coagulation disorders * acute diverticulitis (Hinchey III and IV) * malignancy * acute vaginal infection * refusal of mandatory preoperative gynecological examination * pregnancy * endometriosis * previous surgery of colon and rectum * strongly retroflexed uterus * acute pelvic disorders, infection

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

Feasibility and safety of the transvaginal operation

Timeframe: 30 days

Trial details

NCT IDNCT01043731

SponsorCantonal Hospital of St. Gallen

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2010-11

View on ClinicalTrials.gov More Sigmoid Diverticulitis (Hinchey I and II) trials