The design of the study: Prospective randomized clinical study conducted in our University Hospitals emergency surgery unit between Jan 2012 and July 2017 for 70 Patients admitted to high grade splenic injuries (III-V). The patients were randomly allocated into two groups: Group (A): includes 35 patients: underwent open splenectomy and Group (B): includes 35 patients: laparoscopic splenectomy. The method for calculating sample size was based on mortality rates from previous paper with study power of 80 and confidence 95 samples in each group will be 35. Patients were randomly allocated using a random sequence computer. Patients were randomly numbered in closed envelopes, which were opened just before the operation. Patients were unaware to the any group until after the study. It is the role of registration office.
Patient selection criteria: patients enrolled in the study are male and non-pregnant female, age 15 years and more, Preoperative sonar and CT evidence of isolated splenic injuries and Blood pressure > 90/60 mmhg, and heart rate < 120 beat. While patients excluded from the study were patients with associated other systems or abdominal injuries, successful non-operative management, or successful embolization and penetrating splenic injuries.
Types of outcome and measurement (study endpoints):
Primary outcome was intraoperative mortality. Secondary outcomes are the long and short term postoperative morbidities (early and delayed complications).
Preoperative workup was done by focused assessed sonography for trauma (FAST) and CT of the abdomen. All patients of the present study subjected to immediate initial resuscitation and primary survey, followed by secondary survey and routine laboratory investigations .After resuscitation and stabilization of the vital signs, abdominal ultrasonography and computed tomography scans were carried out for all cases. (Pic 1).Preoperative consultant anesthetist’s assessment. Nasogastric tube and urinary bladder catheter. With induction of anesthesia, metronidazole 500 mg and ceftriaxone 1gm. given intravenously. General anesthesia with cuffed endotracheal intubation. All surgeries were done in mono-center in trauma surgery unit for duration of 5years by 3 surgeons qualified in laparoscopic splenectomy surgery following the principles of laparoscopic surgery. Each surgeon had an experience of previous 100 laparoscopic splenectomies for elective cases. At least one of three senior surgeons was always present to ensure inclusion criteria.
A laparoscope of 30 ° was inserted following induction of pneumoperitoneum (12 mm Hg) with a Veress needle, and a massive hemoperitoneum was visualized and aspired by suction irrigation device. Three additional trocars, left side to umbilical port for the surgeon, and third left side for the assistant were laid in the epigastrium .Careful abdominal cavity inspection confirmed the spleen was the sole source of bleeding (pic 2). The spleno-colic ligament was broken downwards . By harmonic scalpel, the shorts of the gastric vessels and the attachments in the lower polar were divided. The splenic artery was prepared and ligated then cut .it is assured that the pancreatic tail was not damaged (pic 3,4). The lateral attachments were divided that allowed splenic mobilizations. With a 3-cm incision and through endobag, the spleen was removed (pic 7).Extensive uncontrolled bleeding is an indication for laparotomy. (pic 5,6).
Postoperatively, Fluid was allowed as tolerated when the patients had open bowel. Antibiotics were continued for 5 days. A drain removed when contains less than 50 C.C for 3 days. Vaccination occurred after 2 weeks of postoperative surgery. The follow up period was one month, six month, twelve month and 18 months after returning home. After returning to home, patients were contacted by mailing, telephone and at outpatient clinic. Techniques of follow up included complete history and physical examination to detect remote complications and Ultrasonography if patients are symptomatizing at any time in the follow up period. No cases lost in the follow up period.
3. Statistical analysis
The data were imported into the Social Sciences Statistical Package (SPSS version 20.0). The following tests were used for testing of difference of significance, depending upon the type of data qualitative as number and percentage quantitative continuous group represented by average ± SD, and Chi square test differential and associate qualitative variable (X2). Differences between quantitative independent groups by t test or Mann Whitney, for significant results P value was set at < 0.05 & < 0.001 for high significant results.