A Randomized, Controlled Trial of Single-incision Laparoscopic (SILS) Versus Conventional Laparoscopic Appendectomy for the Treatment of Acute Appendicitis

EXPERIMENTAL DESIGN AND METHODS Patient Enrollment: The study population will consist of patients who come to the emergency room with acute abdominal pain and are found to have acute appendicitis on the basis of clinical evaluation and CT of the abdomen/pelvis. At UCSF, such patients are first evaluated by a small group of general surgeons who provide emergency consultations. Once a decision to operate has been made on clinical grounds, the principal investigator (Dr. Carter) or his delegate will be contacted to approach the patient for enrollment and informed consent.

All patients will receive standard care which consists of preoperative broad-spectrum antibiotics consisting of Zosyn, Ertapenem, or Cipro/Flagyl and intravenous fluids.

Surgeon Enrollment: All surgeons at UCSF who take call in the Emergency Department routinely perform conventional laparoscopic appendectomy for acute appendicitis. Surgeons wishing to participate in the trial will perform 5 proctored SILS appendectomies outside of the trial before enrolling patients. We chose the number 5 because one study showed that SILS operative times (a surrogate for procedural mastery) leveled off by the 5th case for surgeons already proficient in laparoscopy.

Randomization: After enrollment, patients will be assigned to conventional laparoscopic appendectomy versus SILS appendectomy in a 1:1 ratio by a computerized random number generator (http://www.random.org). Even-numbered patients will receive conventional laparoscopic appendectomy, odd-numbered will receive SILS appendectomy.

Conventional laparoscopic appendectomy technique: Patients are placed in the supine position and given a general anesthetic. An orogastric tube is placed. Sequential compression devices are placed on the legs. Unless the patient has just voided, a Foley catheter is placed in the bladder. The left arm is tucked and the abdomen shaved as necessary. The umbilical skin is anesthetized with 5mL of 0.25% marcaine. A 1.5cm vertical or transverse skin incision is made within the umbilical stalk, the fascia is retracted, and a 1.5cm vertical fascial incision made with a scalpel. A 12mm Hasson port is placed through the fascia and the abdomen insufflated to 15mmHg with carbon dioxide gas. Alternatively, a small nick in the fascia can be made, a Veress needle used to achieve pneumoperitoneum, and a 12mm VersSTEP port placed through an introducer sheath. Diagnostic laparoscopy is then performed, with inspection of the stomach, liver, gallbladder, colon, small intestines, and pelvis. If a diagnosis other than acute appendicitis is made (such as pelvic inflammatory disease, sigmoid diverticulitis, cecal diverticulitis, Crohn's disease, perforated duodenal ulcer, etc.), the patient is excluded from the study and treated appropriately. If the appendix looks normal and no other pathology is found in the abdomen, the patient may stay enrolled in the study if the surgeon decides to remove the appendix.