Setting:
In this study, we conducted a randomized control trial to investigate the efficacy of two distinct surgical approaches (Thoracotomy vs VATS) for the treatment of pulmonary hydatid cysts. Randomization was carried out using a random number generator, with odd numbers assigned to the open surgical approach and even numbers allocated to the VATS approach. This method ensured the unbiased assignment of patients to their respective treatment groups. While the data collectors were blinded to the treatment allocation, the operating surgeons were not blinded due to the nature of the surgical procedures. The study was conducted during three years (March 2020 to March 2023).
The primary outcomes were While the secondary outcomes were post operative pain control, hospital length of stay, presence of post operative complications and early return to work.
Trial registry
In accordance to the Declaration of Helsinki, the trial was registered in researchregistry, the registration number for this study is Research Registry 8813, with a registration date of April 4, 2023. The details can be found on Browse the Registry - Research Registry
Sample size
as the study was a pilot trial, the sample was kept small (50 consecutive cases) to assess the feasibility, safety and superiority of VATS in the management of pulmonary hydatid cyst.
Inclusion criteria
any case with suspected pulmonary hydatid cyst with the size at least 3 cm.
Exclusion criteria
simultaneous operation for other hydatid cysts like hepatic hydatid cyst, pulmonary hydatid cyst less than 3 cm. emergency presentation like tension pneumothorax, and sepsis.
Preoperative diagnosis
all suspected cases of hydatid cysts had complete blood count, chest x.ray and computed tomography (CT) scan with I.V contrast. When the diagnosis was in doubt, immunological studies for hydatid cysts were requested.
Operative details
the patients received single injection of antibiotic 2 hours before the intervention (ceftriaxone vial 1gm, iv). All procedures were performed under general anesthesia, in lateral position. For thoracotomy group, classical thoracotomy was performed through the fifth intercostal space centered at the posterior axillary line. For the VATS group, the 3–5 cm incision done in the same place. The cysts were located and removed after isolation and controlled evacuation for both group, the space was wiped by swap wetted with hypertonic saline and diluted povidone iodine (Fig. 1). Capitonnage was performed, hemo- and ero-stasis were done. The pleural cavity was irrigated by hypertonic saline. Chest tube was put for both groups in a separated incision. All of the procedures were performed by a single surgeon (the author).
Postoperative care
the patients were admitted to the ward, they were given I.V. antibiotics for the hospitalized period, the management of pain started by re-assurance, I.V. paracetamol, Ketorolac, if the patient still has pain, pethidine was given (50 mg subcutaneously). The criteria for chest tube removal were absence air leak and expanded lung both on clinical examination and chest.ray after removal of chest tubes, the patients were discharged home with oral antibiotic (ciprofloxacin 500 mg x2) and analgesic for further five days. All patients from both groups were put on albendazole 12 mg/kg, started directly after the operation continuing for six months, every month the drug was discontinued for one week (3 weeks/month medication). The patient underwent CT scan of the chest once every six months for 2 years. The patients were followed up for a median duration of 2 years, ranging from 6 months to 3 years.
For pain measurement, the pain scale score tool were used to quantity pain 0-no pain, 1- mild pain, 2- moderate pain, 3- severe pain.