Acute nonspecific abdominal pain: A randomized, controlled trial comparing early laparoscopy versus clinical observation.

AIMS: To evaluate, in a prospective, randomized, single-institution trial, the role of early laparoscopy in the management of nonspecific abdominal pain (NSAP) in young women. PATIENTS AND METHODS: Women aging from 13 to 45 years, admitted for NSAP at the emergency department, were included in the study. Exclusion criteria were pregnancy, previous appendectomy, contraindications to laparoscopy, diagnosis of malignancy, or chronic disease. NSAP was defined as an abdominal pain in right iliac or hypogastric area lasting more than 6 hours and less than 8 days, without fever, leukocytosis, or obvious peritoneal signs and uncertain diagnosis after physical examination and baseline investigations including abdominal sonography. Patients were randomly assigned to early (<12 hours from admission) laparoscopy group (LAP) or to clinical observation group (OBS). After discharge a follow-up was carried out.
RESULTS: From January 2001 to February 2004, 508 female patients without previous abdominal surgery were evaluated in admitting area for acute right iliac or hypogastric abdominal pain, in 373 patients diagnosis was established for obvious signs or with baseline investigations. Of the remaining 135 patients, 31 were excluded from study for various reasons, 53 patients were randomly assigned to LAP and 51 to OBS. Groups were similar for age, mean BMI, white blood cell count, and duration of pain. During hospitalization diagnosis was established in 83.4% of the LAP and in 45.1% of OBS (P < 0.05). Twenty patients of OBS (39.2%) were operated during observation because of worsening of symptoms or appearance of peritoneal sign. Diagnoses in LAP were appendicitis in 16 patients (30.1%), pelvic inflammatory disease in 7 (13.2%), carcinoid in 1 (1.9%), other in 18 (33.9%), no diagnosis in 11 (20.7%); diagnoses in OBS were appendicitis in 3 patients (5.8%), pelvic inflammatory disease in 8 (15.6%), other in 12 (23.5%), and no diagnosis in 28 (54.9%). Mean length of hospital stay was 3.7 +/- 0.8 days in LAP and 4.7 +/- 2.4 days in OBS (P < 0.05); no differences were found regarding mortality, morbidity, radiation dose, and analgesia. Mean follow-up time was 29.3 months (range, 12-60 months) for LAP and 30.6 months for OBS (range, 12-60 months). After 3 months from discharge, 20% of patients in LAP and 52% in OBS had recurrent abdominal pain (P < 0.05); after 12 months, 16% in LAP and 25% in OBS (P = not significant). Six patients in OBS required readmission for surgery.
CONCLUSIONS: Compared with active clinical observation, early laparoscopy did not show a clear benefit in women with NSAP. A higher number of diagnosis and a shorter hospital stay in the LAP group did not led to a significant reduction in symptoms recurrences at 1 year.

RCT Entities:   Population Interventions Outcomes