Trial Outcomes & Findings for Single-incision Laparoscopic (SILS) Versus Conventional Laparoscopic Appendectomy for the Treatment of Acute Appendicitis (NCT NCT00997516)

NCT ID: NCT00997516

Last Updated: 2014-08-22

Results Overview

Mean pain score during 12 hours post-surgery, assessed by the ward nurse as needed, but at least every 4 hours, and documented in the patient's chart. Patients were asked to rate their pain on a scale of 0 to 10, with 10 being the most severe pain imaginable and 0 being no pain at all.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 75 participants
• Primary outcome timeframe: 12 hours post-surgery
• Results posted on: 2014-08-22

Participant Flow

The study population consisted of all patients from May 2010 to November 2012 who presented to the emergency department and were diagnosed with acute appendicitis on the basis of clinical and radiographic evaluation.

88 patients were assessed for eligibility. 5 patients were excluded because the study surgeon was unavailable to perform the procedure. 6 patients declined to participate.

Participant milestones

Measure	SILS Appendectomy SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy	Conventional Laparoscopic Appendectomy Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
Short-term Follow-up (Post Operative) STARTED	37	38
Short-term Follow-up (Post Operative) COMPLETED	37	38
Short-term Follow-up (Post Operative) NOT COMPLETED	0	0
Long-term Follow-up (After 6 Months) STARTED	37	38
Long-term Follow-up (After 6 Months) COMPLETED	31	36
Long-term Follow-up (After 6 Months) NOT COMPLETED	6	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Single-incision Laparoscopic (SILS) Versus Conventional Laparoscopic Appendectomy for the Treatment of Acute Appendicitis

Baseline characteristics by cohort

Measure	SILS Appendectomy n=37 Participants SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy	Conventional Laparoscopic Appendectomy n=38 Participants Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix	Total n=75 Participants Total of all reporting groups
Age, Continuous	34 years STANDARD_DEVIATION 11 • n=93 Participants	35 years STANDARD_DEVIATION 12 • n=4 Participants	34 years STANDARD_DEVIATION 10 • n=27 Participants
Sex: Female, Male Female	18 Participants n=93 Participants	14 Participants n=4 Participants	32 Participants n=27 Participants
Sex: Female, Male Male	19 Participants n=93 Participants	24 Participants n=4 Participants	43 Participants n=27 Participants
Region of Enrollment United States	37 participants n=93 Participants	38 participants n=4 Participants	75 participants n=27 Participants

PRIMARY outcome

Timeframe: 12 hours post-surgery

Mean pain score during 12 hours post-surgery, assessed by the ward nurse as needed, but at least every 4 hours, and documented in the patient's chart. Patients were asked to rate their pain on a scale of 0 to 10, with 10 being the most severe pain imaginable and 0 being no pain at all.

Outcome measures

Measure	SILS Appendectomy n=37 Participants SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy	Conventional Laparoscopic Appendectomy n=38 Participants Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
Pain After Surgery	4.4 units on a scale Standard Deviation 1.6	3.5 units on a scale Standard Deviation 1.5

SECONDARY outcome

Timeframe: up to 6 hours

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.

Outcome measures

Measure	SILS Appendectomy n=37 Participants SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy	Conventional Laparoscopic Appendectomy n=38 Participants Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
Operative Time	54 minutes Standard Deviation 17	38 minutes Standard Deviation 12

SECONDARY outcome

Timeframe: during surgery , up to 6 hours

Patients requiring use of additional incisions and/or trocars, or the need to perform an open procedure.

Outcome measures

Measure	SILS Appendectomy n=37 Participants SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy	Conventional Laparoscopic Appendectomy n=38 Participants Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
Procedures Requiring Conversion to Open or Additional Port	1 participants	0 participants

SECONDARY outcome

Timeframe: during surgery, up to 6 hours

Number of participants who required intervention (suture or stapled repair, use of hemostatic agents) for injury to the intestines, colon, omentum, vasculature, or pelvic organs during the dissection.

Outcome measures

Measure	SILS Appendectomy n=37 Participants SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy	Conventional Laparoscopic Appendectomy n=38 Participants Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
Visceral or Vascular Injury	0 participants	0 participants

SECONDARY outcome

Timeframe: up to 14 days

Number of calendar days the participant was hospitalized.

Outcome measures

Measure	SILS Appendectomy n=37 Participants SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy	Conventional Laparoscopic Appendectomy n=38 Participants Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
Length of Stay	1.4 Days Standard Deviation 0.8	1.6 Days Standard Deviation 1.8

SECONDARY outcome

Timeframe: 6 months

Number of participants who required additional antibiotics, prescribed beyond the perioperative antibiotics given for acute appendicitis, for the purpose or treating a wound cellulitis.

Outcome measures

Measure	SILS Appendectomy n=37 Participants SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy	Conventional Laparoscopic Appendectomy n=38 Participants Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
Wound Infection	0 participants	0 participants

SECONDARY outcome

Timeframe: 6 months

Number of participants who required reoperation, readmission, or percutaneous drainage of a deep (organ space) infection within 6 months of surgery. All intra-abdominal abscesses were classified as deep space infections.

Outcome measures

Measure	SILS Appendectomy n=37 Participants SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy	Conventional Laparoscopic Appendectomy n=38 Participants Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
Deep Space Infection	1 participants	0 participants

SECONDARY outcome

Timeframe: 6 months

Number of participants who experienced un-inflamed fluid collection under the skin incision > 1cm in diameter identified within 6 months of surgery.

Outcome measures

Measure	SILS Appendectomy n=37 Participants SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy	Conventional Laparoscopic Appendectomy n=38 Participants Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
Wound Seroma	1 participants	0 participants

SECONDARY outcome

Timeframe: 30 days

Number of calendar days between participants' discharge from the hospital and the first day back at work.

Outcome measures

Measure	SILS Appendectomy n=37 Participants SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy	Conventional Laparoscopic Appendectomy n=38 Participants Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
Time to Return to Work	8.1 Days Standard Deviation 6.2	6.9 Days Standard Deviation 4.1

SECONDARY outcome

Timeframe: 30 days

Number of participants readmitted to the hospital within 30 days of surgery

Outcome measures

Measure	SILS Appendectomy n=37 Participants SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy	Conventional Laparoscopic Appendectomy n=38 Participants Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
Readmission Within 30 Days.	2 participants	1 participants

SECONDARY outcome

Timeframe: 6 months

Population: 67 of 75 patients completed and returned follow-up surveys

After a minimum of 6 months, a Body-Image Questionnaire was sent to participants. The questionnaire has 5 questions, with answers ranging from 1 (Extremely) to 4 (Not at all); lower scores indicate worse satisfaction with and perception of bodily appearance.

Are you less satisfied with our body since the operation? Do you think the operation has damaged your body? Do you feel less attractive as a results of your operation? Do you feel less feminine or masculine as a result of your operation? Is it difficult to look at yourself naked?

Outcome measures

Measure	SILS Appendectomy n=31 Participants SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy	Conventional Laparoscopic Appendectomy n=36 Participants Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
Body Image Score at 6 Months Overall body satisfaction	3.5 units on a scale Standard Deviation 1.0	3.7 units on a scale Standard Deviation 0.6
Body Image Score at 6 Months Damage to body from operation	3.7 units on a scale Standard Deviation 0.4	3.8 units on a scale Standard Deviation 0.4
Body Image Score at 6 Months Physical attractiveness affected by operation	3.8 units on a scale Standard Deviation 0.4	4.0 units on a scale Standard Deviation 0.4
Body Image Score at 6 Months Femininity/masculinity affected by operation	4.0 units on a scale Standard Deviation 0.0	4.0 units on a scale Standard Deviation 0.2
Body Image Score at 6 Months Looking at oneself naked	3.9 units on a scale Standard Deviation 0.3	3.9 units on a scale Standard Deviation 0.2

SECONDARY outcome

Timeframe: 6 months

Population: Participants who returned surveys for long-term follow-up

The Cosmetic Appearance Scale assessed the degree of satisfaction with the physical appearance of the abdomen (and its scars) using a visual analogue scale. Numeric scores were obtained by measuring the horizontal distance from the low end of the scale to the marking, and then normalized on a scale of 0-20 points. Higher scores indicate a higher degree of satisfaction.

Since your operation, how would you describe the overall appearance of your abdomen? (Revolting; Beautiful) Since your operation, how would you describe your incisional scars? (Revolting; Beautiful) How satisfied are you with your incisional scars? (Very unsatisfied; Very satisfied) How much discomfort do your incisional scars cause? (Severe, daily pain; No pain at all) Can you score your own incisional scar? (Worst possible scar; Best possible scar)

Outcome measures

Measure	SILS Appendectomy n=31 Participants SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy	Conventional Laparoscopic Appendectomy n=36 Participants Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
Satisfaction With Physical Appearance of Abdomen and Scars at 6 Months. Discomfort of scars	18.6 units on a scale Standard Deviation 2.9	18.6 units on a scale Standard Deviation 2.4
Satisfaction With Physical Appearance of Abdomen and Scars at 6 Months. Appearance of abdomen	16.3 units on a scale Standard Deviation 3.5	15.4 units on a scale Standard Deviation 3.7
Satisfaction With Physical Appearance of Abdomen and Scars at 6 Months. Appearance of scars	16.5 units on a scale Standard Deviation 3.2	14.4 units on a scale Standard Deviation 4.1
Satisfaction With Physical Appearance of Abdomen and Scars at 6 Months. Satisfaction with scars	18.5 units on a scale Standard Deviation 2.2	16.9 units on a scale Standard Deviation 3.7
Satisfaction With Physical Appearance of Abdomen and Scars at 6 Months. Overall impression of scars	18.4 units on a scale Standard Deviation 2.7	16.4 units on a scale Standard Deviation 3.0

Adverse Events

SILS Appendectomy

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Conventional Laparoscopic Appendectomy

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	SILS Appendectomy n=37 participants at risk SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy	Conventional Laparoscopic Appendectomy n=38 participants at risk Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
Infections and infestations Deep space infection	2.7% 1/37 • 6 months	0.00% 0/38 • 6 months
Skin and subcutaneous tissue disorders Wound seroma	2.7% 1/37 • 6 months	0.00% 0/38 • 6 months
Injury, poisoning and procedural complications Postoperative bleeding	0.00% 0/37 • 6 months	2.6% 1/38 • 6 months
Renal and urinary disorders Urinary retention	5.4% 2/37 • 6 months	5.3% 2/38 • 6 months
Gastrointestinal disorders Prolonged postoperative ileus	2.7% 1/37 • 6 months	2.6% 1/38 • 6 months

Additional Information

Jonathan T. Carter, MD, FACS

University of California, San Francisco

Phone: 415-476-0974

Email: jonathan.carter@ucsfmedctr.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place