Gallbladder Polyps, Gallstone
Conditions
Keywords
laparoscopic cholecystectomy, single site, randomized controlled trail
Brief summary
The purpose of this study is to scientifically evaluate the safety, efficacy and cosmetic results of transumbilical laparoendoscopic single site cholecystectomy.
Detailed description
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 .
Interventions
PROCEDURECLC
CLC（4 ports or 3 ports）will be performed in a routine fashion by one full time faculty member with fellowship training in laparoscopy.
PROCEDURETU-LESSC
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.
Sponsors
Beijing Friendship Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 18 Years to 5 Years * Benign gallbladder diseases * KPS ≥ 70 * informed consent
Exclusion criteria
* Obstructive jaundice * Broadening of the common bile duct * Gallstone pancreatitis * Serious heart,brain,lung, metabolic diseases history * History of upper abdominal surgery * Pregnancy or breast-feeding women * Refuse TU-LESSC * BMI(Body Mass Index)≥ 30
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the incidence of surgical complications | up to 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| quality of life scores | up to 12 weeks | Count patients' quality of life scores before sugery and at several time points after operation. |
| pain scores | up to 12 weeks | Use VAS（Visual Analogue Score）to count patients' pain scores at several time points after operation. |
| length of hospital stay | participants will be followed for the duration of hospital stay, an expected average of 5 days | — |
| transfer rate | participants will be followed for the duration of hospital stay, an expected average of 5 days | TU-LESSC（transumbilical laparoendoscopic single site cholecystectomy）is converted to LC（laparoscopic cholecystectomy）or open sugery;LC is converted to open sugery. |
| Cosmetic results | 1 month | Through the incision length and patients' satisfaction to assess cosmetic results. |
| The incidence of adverse events | up to 12 weeks | 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. |
| total cost of hospitalization | participants will be followed for the duration of hospital stay, an expected average of 5 days | — |
Countries
China
Contacts
Primary ContactYang Liu, master
Backup ContactWei Guo, doctor
Outcome results
None listed