Single-incision Laparoscopic (SILS) Versus Conventional Laparoscopic Appendectomy for the Treatment of Acute Appendicitis
Single-incision Laparoscopic (SILS) Versus Conventional Laparoscopic Appendectomy for the Treatment of Acute Appendicitis
Recent advances in laparoscopic instrumentation have made it possible to perform
 intra-abdominal operations entirely through a small incision that can be hidden within the
 umbilicus. The goal is to perform surgery with fewer incisions and no visible scars. Other
 potential benefits are faster recovery, less pain, and fewer wound complications. The term
 SILS (Single Incision Laparoscopic Surgery) is being used to describe such techniques, and
 many have touted SILS as a major breakthrough in minimally-invasive surgery, moving the field
 closer to surgery that is bloodless, incisionless, and painless. Despite the hype,
 prospective comparisons of SILS versus conventional laparoscopy are lacking. Results of SILS
 procedures have generally been limited to case reports and small case series that lack
 controls. The investigators propose to conduct a prospective, randomized, single-center trial
 of SILS appendectomy versus conventional laparoscopic appendectomy to treat acute
 appendicitis. Primary end-points are operative time, complication rate, postoperative pain,
 recovery time, and long-term cosmetic outcome. The investigators hypothesize SILS
 appendectomy is equivalent to laparoscopic appendectomy with respect to operative time,
 complication rate, postoperative pain, and recovery time while providing a better cosmetic
 outcome.
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.

 Additional 5mm ports are placed in the left lower quadrant and suprapubic midline after the
 skin and peritoneum are anesthetized with 0.25% marcaine. A 5mm camera is transferred to the
 left lower quadrant port site and the appendix is exposed and retracted anteriorly. The
 mesoappendix may be divided with EndoGIA staplers, Ligasure, cautery and clips, or Harmonic
 Scalpel. The base of the appendix may be ligated with EndoGIA staplers or Endoloop. The
 appendix is removed through the umbilical incision after first placing it into an EndoCatch
 bag. Minimal irrigation is used; perforated cases are treated with suctioning of
 intra-abdominal pus and postoperative antibiotics. Blood loss is estimated. Umbilical fascia
 length is measured in millimeters, then closed with 0-Maxon absorbable suture. The umbilical
 skin is anesthetized with 0.25% marcaine, and all skin edges re-approximated with 4-0 biosyn.
 Indermil glue is the only dressing.

 SILS 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 base of the umbilical stalk is everted
 by two penetrating towel clamps placed either side of the midline. The skin is anesthetized
 with 5mL of 0.25% marcaine. A vertical skin incision is made within the umbilical stalk, the
 fascia is retracted, and a 3 cm vertical fascial incision made with a scalpel. The peritoneum
 is entered with either a gloved finger, Kelly clamp, or scissors. The incision is retracted
 anteriorly with an Army/Navy retractor, and the SILSPort inserted into the incision using a
 shoe-horn maneuver. 5mm trocars are placed in the SILSPort™, and the abdomen insufflated to
 15mmHg with carbon dioxide gas, after which the trocars are repositioned into a staggered
 elevation. 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.

 The appendix is exposed and retracted anteriorly. The mesoappendix may be divided with
 EndoGIA staplers, Ligasure, cautery and clips, or Harmonic Scalpel. The base of the appendix
 may be ligated with EndoGIA staplers or Endoloop. When staplers are used, one of the 5mm
 trocars is replaced with a 12mm trocar. The appendix is removed through the umbilical
 incision after first placing it into an EndoCatch bag. Minimal irrigation is used; perforated
 cases are treated with suctioning of intra-abdominal pus and postoperative antibiotics. Blood
 loss is estimated. Umbilical fascia length is measured in millimeters, then closed with
 0-Maxon absorbable simple interrupted sutures. Skin edges re-approximated with 4-0 biosyn.
 Indermil glue is the primary dressing.

 Postoperative Care: Patients are given a full liquid diet immediately after surgery, and are
 advanced to an unrestricted diet as soon as the patient feels up to it. Pain is controlled by
 a hydromorphone PCA (patient-controlled analgesia) pump for at least 12 hours after surgery,
 after which oral pain medications are prescribed. If the patient is allergic to
 hydromorphone, morphine may be used. No supplemental pain medications (Motrin, Toradol, etc.)
 will be used for patients enrolled in the study. No steroids (e.g. Decadron) will be given.
 Antibiotics for appendicitis are given at the discretion of the attending surgeon. Patients
 are discharged at the discretion of the attending surgeon, generally when the patient can eat
 without vomiting, pain is controlled with oral medications, and the systemic inflammatory
 response to the appendicitis has subsided.

 After 2-3 weeks, follow-up occurs in Dr. Carter's clinic. The wounds are assessed for
 infection, seroma, or hernia. Date of return-to-work and date of last opiate pain medication
 are recorded. At 6 months, patients return to clinic and complete a survey. The survey
 includes a Body Image Questionnaire, a Cosmetic Appearance Scale, and a Photo Series
 Questionnaire, all of which have been validated.8-12 The Body Image Questionnaire measures
 patients' perception of and satisfaction with their own body and explores attitudes toward
 their bodily appearance. Five questions are asked, with up to four points assigned per
 question, totaling 20 possible points. The Cosmetic Appearance Scale assesses the degree of
 patient satisfaction about the physical appearance of the abdomen (and its scars) using
 100-mm visual analogue scale. The patient is asked to make a mark along the horizontal scale
 that indicates the overall aesthetic appearance of the abdomen as a whole, and incisions
 separately. Numeric scores are then obtained by measuring the horizontal distance from the
 low end of the scale to the marking, rounded to the nearest millimeter. Finally, the Photo
 Series Questionnaire assesses whether knowledge of the cosmetic results of the alternative
 approach (SILS or conventional laparoscopic) influences the evaluation of the scar. It also
 measures the strength of the preference. Patients who do not return for follow-up will be
 mailed a survey and/or called for a telephone interview. Data management and interviews will
 be managed by a research assistant hired for the study.

 Definition of Study Variables and Outcome Measures Patient Characteristics: Age, height,
 weight, prior operations in the abdomen

 Intraoperative Variables:

 1. Operative time - defined as the amount of time to perform the operation from
 skin-incision to application of the dressing. This time is routinely charted by the
 circulating nurse in the operating room.

 2. Conversion - defined by the use of incisions and/or trocars in addition to the ones
 described in the Methods section, or the need to perform an open procedure.

 3. Visceral or vascular injury - defined as injury to the intestines, colon, omentum,
 vasculature, or pelvic organs during the dissection requiring intervention (suture or
 stapled repair, use of hemostatic agents).

 4. Umbilical fascia incision length (in millimeters).

 Postoperative Variables:

 1. Mean pain score over 12 hours - Pain is assess by the ward nurse as needed, but at least
 every four hours, and documented in the patient's chart. Pain is scored on a scale of
 0-10, 10 being the most severe pain imaginable. Average pain score for that patient is
 calculated over the first 12 hours (the time the patient is on a hydromorphone PCA)

 2. Hydromorphone use over 12 hours - Total hydromorphone usage (in milligrams) is charted
 by the floor nurse. The amount used in the first 12 hours after surgery, starting from
 the time the patient is discharged from the recovery room, is recorded.

 3. Length of stay - Number of calendar days the patient is hospitalized.

 4. Wound infection - Defined as the need for additional antibiotics, prescribed beyond the
 perioperative antibiotics given for acute appendicitis, for the purpose or treating a
 wound cellulitis, or the need to open the wound to drain a wound abscess, within 6
 months of surgery.

 5. Deep space infection - Defined as the need for reoperation, readmission, or percutaneous
 drainage of a deep (organ space) infection within 6 months of surgery. All
 intra-abdominal abscesses are classified as deep space infections.

 6. Wound seroma - Defined as an un-inflamed fluid collection under the skin incision > 1cm
 in diameter identified within 6 months of surgery.

 7. Time to return to work - Defined as the number of calendar days between discharge from
 the hospital and the first day back at work.

 8. Date of last opiate pain medication use.

 9. Readmission with 30 days.

 10. Body Image Score at 6 months

 11. Cosmetic Appearance Scale at 6 months.

 12. Photo Series Questionnaire at 6 months.
Inclusion Criteria:

 1. Suspected acute appendicitis on clinical and radiographic (CT) grounds

 Exclusion Criteria:

 1. Phlegmon, mass, peri-appendicecal abscess, or diffuse peritonitis

 2. Prior open laparotomy with incision through the umbilicus

 3. Body Mass Index > 35

 4. Age <18 years

 5. Mental illness, dementia, or inability to provide informed consent

 6. Chronic pain requiring daily medication (including opiate and NSAIDs)

 7. Pregnancy

 8. Alternative diagnosis found by diagnostic laparoscopy (post-randomization)