A Phase 2/3 interventional study of CLC and TU-LESSC in Gallstone and Gallbladder Polyps, sponsored by Beijing Friendship Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2011-07-07.
Sponsored by Beijing Friendship Hospital · Phase 2/3, Interventional, and Treatment
The purpose of this study is to scientifically evaluate the safety, efficacy and cosmetic results of transumbilical laparoendoscopic single site cholecystectomy.
As the natural orifice during embryonic, the transumbilical surgery not only can mask the abdominal scar and avoid infection produced by puncturing stomach, vagina or rectum in NOTES,but also can be played by the conventional laparoscopic instruments. TU-LESS (transumbilical laparoendoscopic single site surgery), is considered to be the most feasible NOTES(natural orifice transluminal endoscopic surgery)technology at present. Researches about TU-LESS mostly are case reports and small samples or the control experiments up to now,there are not persuasive randomized controlled trail between TU-LESS and conventional laparoscopic cholecystectomy. So the investigators design this prospective randomized controlled trail to scientifically evaluate the safety, efficacy and cosmetic results of transumbilical laparoendoscopic single site cholecystectomy .
346 studies on the registry are indexed under Gallstones; 46 are open to participants now.
This study's planned enrollment of 600 is above the median of 99 across 232 interventional studies indexed under Gallstones.
Browse Gallstones studies →Beijing Friendship Hospital is the lead sponsor of 216 studies on the registry; 95 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Laparoscopic cholecystectomy（4 ports or 3 ports）will be performed in a routine fashion by one full time faculty member with fellowship training in laparoscopy.
Procedure: CLC
TU-LESSC will be performed in a routine fashion which is same to CLC（conventional laparoscopic cholecystetomy）by one full time faculty member with fellowship training in laparoscopy through the conventional laparoscopic instruments.
Procedure: TU-LESSC
CLC（4 ports or 3 ports）will be performed in a routine fashion by one full time faculty member with fellowship training in laparoscopy.
Also known as: conventional laparoscopic cholecystectomy
TU-LESSC will be performed in a routine fashion which is same to CLC by one full time faculty member with fellowship training in laparoscopy through the conventional laparoscopic instruments.
Also known as: Transumbilical laparoendoscopic single site cholecystectomy
the incidence of surgical complications
The primary outcome messures are the incidence of surgical complications caused by the two surgeries.Bleeding,bile duct injury and bile leakage during operation.Wound infection，umbilical hernia，poke holes hernia and biliary fistula after operation.
Time frame: up to 12 weeks
transfer rate
TU-LESSC（transumbilical laparoendoscopic single site cholecystectomy）is converted to LC（laparoscopic cholecystectomy）or open sugery;LC is converted to open sugery.
Time frame: participants will be followed for the duration of hospital stay, an expected average of 5 days
quality of life scores
Count patients' quality of life scores before sugery and at several time points after operation.
Time frame: up to 12 weeks
pain scores
Use VAS（Visual Analogue Score）to count patients' pain scores at several time points after operation.
Time frame: up to 12 weeks
length of hospital stay
Time frame: participants will be followed for the duration of hospital stay, an expected average of 5 days
total cost of hospitalization
Time frame: participants will be followed for the duration of hospital stay, an expected average of 5 days
Cosmetic results
Through the incision length and patients' satisfaction to assess cosmetic results.
Time frame: 1 month
The incidence of adverse events
The adverse events occurred after surgery，regardless of whether they are caused by the tow operations。 Such as nausea, dizziness, urinary retention, vomiting and so on.
Time frame: up to 12 weeks
This study is status unknown, as verified in Oct 2010. You cannot join it, but the record below documents what was studied.
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Beijing Friendship Hospital