This article has been cited by other articles in PMC. Abstract Summary Background Data: The value of laparoscopy in appendicitis is not established. Studies suffer from multiple limitations. Our aim is to compare the safety and benefits of laparoscopic versus open appendectomy in a prospective randomized double blind study. Methods: Two hundred forty-seven patients were analyzed following either laparoscopic or open appendectomy. A standardized wound dressing was applied blinding both patients and independent data collectors.
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This article has been cited by other articles in PMC. Abstract Summary Background Data: The value of laparoscopy in appendicitis is not established. Studies suffer from multiple limitations. Our aim is to compare the safety and benefits of laparoscopic versus open appendectomy in a prospective randomized double blind study. Methods: Two hundred forty-seven patients were analyzed following either laparoscopic or open appendectomy.
A standardized wound dressing was applied blinding both patients and independent data collectors. Surgical technique was standardized among 4 surgeons. The main outcome measures were postoperative complications.
Secondary outcome measures included evaluation of pain and activity scores at base line preoperatively and on every postoperative day, as well as resumption of diet and length of stay. Activity scores and quality of life were assessed on short-term follow-up. Results: There was no mortality. The overall complication rate was similar in both groups At 2 weeks, there was no difference in the activity or pain scores, but physical health and general scores on the short-form 36 SF36 quality of life assessment forms were significantly better in the laparoscopic group.
Conclusions: Unlike other minimally invasive procedures, laparoscopic appendectomy did not offer a significant advantage over open appendectomy in all studied parameters except quality of life scores at 2 weeks. It also took longer to perform. The choice of the procedure should be based on surgeon or patient preference. Key Words: appendicitis, appendectomy, laparoscopy Since its initial description by Semm 1 in , laparoscopic appendectomy LA has struggled to prove its superiority over the open technique.
This is in contrast to laparoscopic cholecystectomy, which has promptly become the gold standard for gallstone disease despite little scientific challenge. The overall mortality of OA is around 0. Numerous prospective randomized studies, 5—26 meta-analyses, 27—30 and systematic critical reviews 31—34 have been published on the topic of LA, with a general consensus that the heterogeneity of the measured variables and other weaknesses in the methodology have not allowed to draw definitive conclusions and generalizations.
All patients included were 16 years of age or older. Randomization The qualifying patients were informed of the risk and benefits of each operation and asked to sign a detailed informed consent in their respective native language, approved by the institutional review board IRB. Baseline evaluation of the following parameters was performed before randomization once the informed consent was signed: measurement of pain on a visual analog scale VAS and measurement of activity using a scoring system.
Computer-generated random numbers were used to assign the type of surgery laparoscopic or open , which were written on a card sealed in a completely opaque envelope. Surgery Residents performed all operations with 4 attending surgeons experienced in open and advanced laparoscopic techniques. The level of expertise in the performance of the standardized LA technique was verified by the senior author NK before the beginning of the trial. Patients received 1 g of cefoxitin every 8 hours intravenously from the time of diagnosis until surgery.
All other patients did not receive any antibiotics postoperatively. No urinary catheter was used. Nasogastric tubes were inserted in patients suspected to have a significant postoperative ileus.
OA used a McBurney muscle-splitting incision 1. A double ligation of the stump was performed with an absorbable suture. The abdomen and pelvis were irrigated with warm saline solution.
In the case of a perforated appendix, the skin wound was closed loosely. LA was performed using 3 ports, with the laparoscope positioned at the umbilicus. Two mm ports were inserted in the right and left lower quadrants. The abdominal cavity was explored to locate the appendix and rule out other possible diagnoses.
The appendix and the mesoappendix were divided with an Endolinear Cutter 45 with blue and vascular staples, respectively Ethicon Endosurgery, Cincinnati, OH. The right lower quadrant, the right colic gutter and the subhepatic space in the case of purulence were irrigated and the fluid was suctioned. The appendix was removed in a laparoscopic bag. Fascial defects in the port sites were closed using 0 Vicryl suture. The skin incisions were closed in every case using nylon.
Nonsuction drainage was left in situ in cases of abscess and residual cavity. Blinding At the end of each procedure, 3 wound dressings and an abdominal binder were applied to every patient to blind the patient, the nursing and the medical staff, and the independent data collector as to the nature of the procedure.
Postoperative Course Strict criteria were followed for the reintroduction of nutrition. Bowel sounds were checked every 12 hours. Once present, the patients were started on a clear liquid diet and advanced to regular diet when the liquid diet was tolerated and flatus observed. All items had response categories scaled from 1 through 5, with verbal descriptors for each item.
The response categories for activity were 1 no difficulty at all; 2 a little difficulty; 3 some difficulty; 4 a lot of difficulty; 5 not able to do it.
The Activity Assessment scale is the sum of the 13 items, with higher scores indicating poorer activity. Pain and discomfort were also assessed qualitatively using 2 items: a pain distress variable and a pain activity scale. The pain distress variable was a single response item that the patients used to indicate on a visual linear scale the severity of the worst pain that they experienced in thepreceding 24 hours.
The item was scaled from 0 to , with 0 being no pain and being the most intense pain imaginable. Qualitative pain scores, activity, and quality-of-life scores were completed. Quality of life was measured with the SF Each item has response categories describing the level of functioning of the patient from normal to severely impaired, as well as physical and mental health summary measures. They represent the most frequently measured concepts in widely used health surveys. It is a generic measure as opposed to the ones that target a specific age, disease, or treatment group.
It has been constructed to satisfy minimum psychometric standard measures for group comparisons. It has been documented in more than publications involving more than diseases and conditions. All comparisons between groups were intention-to-treat analyses in which patients were analyzed according to the assigned treatment group.
Conversions to open were therefore analyzed in the laparoscopic group. Statistical analyses of quality-of-life outcomes and the quality-of-pain assessments were evaluated using the differences between theopen group and the laparoscopic group with respect to the change from preoperative scores for each time point.
The change in scores for the SF QOL form, the activity assessment scale, the pain activity scales, and the pain distress score was compared using Wilcoxon rank-sum tests separately for each time point. There were missing data in 10 patients in the laparoscopic group. To exclude any bias and to determine the effect of the missing data, a second analysis was performed in which we inputted values equal to the 25th percentile for all the responding patients in that group.
The inputted values were set for the worst and best possible scenarios, and a reanalysis was performed. In all but 2 cases, the second analysis produced results similar to the primary analysis. The exceptions were with regard to time of oral intake of liquid and solid foods. When the inputted values for time to oral feeding were set to the worst level, there was a statistically significant difference in the time to oral intake of liquids in the favor of the laparoscopic group.
When the inputted values were set to the best possible score for the oral intake, there was a statistical difference in the time to oral intake of solid and foods, which also favored the laparoscopic group.
All continuous variables are expressed as median interquartile range. Eleven were excluded from the study 10 refused treatment assignment and 1 was pregnant; see Fig. There were missing data in 10 patients; therefore, were available for the analysis. Patient allocation. Demographics The 2 groups were similar with respect to age, sex, and preoperative white cell count Table 1.
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