Morino 2006.
| Methods | Design of RCT: parallel clinical trial Power calculation: not stated No blinding used Follow‐up: at one week, three and 12 months 104 participants recruited, 104 randomly assigned 31 participants excluded before random assignment Lost to follow‐up at three months: five in each group; at 12 months: nine in the laparoscopy group and seven in the conventional group 104 women analysed "Single centre: from the Chirurgia Generale II e Centro di Chirurgia Mini Invasiva Department of Surgery, University of Turin, Turin, Italy" Enrolment between January 2001 and February 2004 Source of funding: not stated Ethical issues: specific informed consent form approved by our institution’s ethics committee Method used to establish definitive diagnosis based on visual examination and surgical pathology when the appendix was removed or bacteriological test of abdominal fluid, if present, in laparoscopic group. Not clearly stated in conventional group |
|
| Participants | Women between 13 and 45 years of age with non‐specific abdominal pain (NSAP) defined as abdominal pain lasting longer than six hours and less than seven days with uncertain diagnoses after clinical examination and baseline investigations, including full blood count, blood urea, amylase and bilirubin, serum electrolytes, urinalysis, pregnancy test, abdominal radiograph and abdominal US. Abdominal pain localised or prevalent in right iliac or suprapubic areas, not accompanied by fever, leucocytosis or clinical signs of peritonitis or haemodynamic instability or other obvious clinical presentation requiring urgent intervention "Exclusion criteria: previous appendectomy or major abdominal surgery, pregnancy, diagnosis of malignancy or chronic disease, contraindications to pneumoperitoneum, patient’s refusal to enter the study and precise diagnoses of: acute appendicitis, inflammatory bowel disease, ectopic pregnancy, endometriosis, urinary infection, renal colic, ovarian cyst, uterine fibroma and IUD associated endometritis after baseline investigations" Mean age (SD): 23.7 years (± 7) in laparoscopy group, 23.2 years (± 6) in conventional group Mean temperature (SD) 36.9 °C (± 0.5) in laparoscopy group, 36.8 °C (± 0.6) in conventional group Mean serum white cell count (DS): 8200 (± 1850) in laparoscopy group, 8730 (± 1600) in conventional group Mean body mass index (SD): 22.1 kg/m2 (± 5) in laparoscopy group, 21.5 (± 3) in conventional group |
|
| Interventions | "Laparoscopic diagnosis in the first 12 hours versus active clinical observation during 48 hours" Laparoscopy performed using an open Hasson technique for the first port placement in the umbilical area. Once 12 mmHg CO2 pneumoperitoneum was created, 2 5‐mm trocars inserted into midline suprapubic area and left iliac area. Abdominal cavity accurately explored in all participants, including complete mobilisation of entire small bowel. When no abnormality identified at laparoscopy, appendicectomy performed whenever serous fluid was present in the abdominal cavity; fluid aspirated and sent for microbiological testing. Attempt made to treat laparoscopically all surgical pathologies diagnosed at laparoscopy Participants randomly assigned to active clinical observation admitted to the surgical ward. Complete clinical examination repeated twice a day, baseline tests repeated at 24 and 48 hours from admission and on the basis of participant's clinical evolution. Once diagnosis was made, treatment immediately started. In the presence of persistent or worsening pain at 48 hours from admission, laparoscopic procedure undertaken. Participants in whom clinical symptoms progressively weakened and finally disappeared before a precise diagnosis were dismissed undiagnosed. Nine participants sent to vaginal ultrasound, four to CT scan, three to plain abdominal radiography and one to abdominal RNM Method used to obtain a definitive diagnosis: visual diagnosis and histopathology for appendicitis, microbiology test for abdominal liquid in laparoscopy group. Visual diagnosis in participants with worsening of pain; if pain disappeared, they were dismissed undiagnosed |
|
| Outcomes | Primary outcomes: number of definitive diagnoses Adverse events: stated in methods and reported "Secondary outcomes: hospitalization time prior of laparoscopy in hours, Mean operative time (minutes), Time of follow up time in months, final hospitalization time in days, patient without diagnosis, laparotomy or abdominal cavity visualization required"; stated in methods and reported |
|
| User defined 1 | ||
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Adequate: randomisation performed by means of sealed opaque envelopes containing computer‐generated random numbers |
| Allocation concealment (selection bias) | Unclear risk | Paper: states only sealed opaque envelopes. No mention whether sequentially numbered or when opened |
| Blinding (performance bias and detection bias) All outcomes | High risk | Open RCT |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not in cases of participants dismissed undiagnosed. No loss to follow‐up reported |
| Selective reporting (reporting bias) | Unclear risk | Protocol of the study not available |
| Free of differential verification bias | Unclear risk | Definitive diagnosis not done using the same reference standard in the two groups |
| Free of partial verification bias | Unclear risk | Non‐random set of participants not undergoing the reference standard |
| Free of Incorporation Bias | High risk | Index test incorporated as reference standard in the laparoscopic group |
| Other bias | Unclear risk | All baseline characteristics not reported |