Complications
Conditions
Keywords
Appendicitis, Appendectomy, Single-incision
Brief summary
Conventional laparoscopic appendectomy(CLA) is the current standard treatment. To obtain additional benefits such as a better cosmetic outcome, the investigators developed a surgical option termed suprapubic single-incision laparoscopic appendectomy (SSILA), which creates a non-visible scar, that was preliminarily shown to be feasible and safe in our previous retrospective studies To further evaluate the feasibility, safety and cosmetic results of this innovative approach, the investigators compared the outcomes of SSILA and CLA by performing a randomized controlled trial.
Interventions
PROCEDUREsuprapubic single-incision laparoscopic appendectomy
the approach of appendectomy
Sponsors
Nanfang Hospital, Southern Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* acute appendicitis or interval appendicitis * informed consent
Exclusion criteria
* diagnosis of appendicitis was not clinically established (symptoms attributable to urinary or gynecological problems) * history of cirrhosis and coagulation disorders * suspected or proven malignancy * contraindication to general anesthesia (severe cardiac and/or pulmonary disease) * inability to give informed consent(severe mental disease) * pregnancy * BMI\>30kg/m2 * generalized peritonitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of complications | 30 days | The early morbidity rate is defined as the event observed during operation and within 30 days after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| mortality rate | 30 days | — |
| cosmetic results | 30 days | Cosmetic assessment is perform using body image scale and cosmetic scale. |
| operative time | intraoperative | — |
| time to recover | 14 days | — |
| Pain score | 14 days | Postoperative pain is recorded using the visual analog scale (VAS) pain score tool on postoperative day 1, 2, 3 and the day of discharge. |
Countries
China
Contacts
Primary ContactGuoxin Li, M.D.,Ph. D.
Backup ContactYanan Wang, M.D
Outcome results
None listed