Comparison of chlorhexidine gluconate 0.04% with hypertonic saline as a scolcidal agent during liver hydatid surgery and the recurrence of hydatid cyst

Comparison of the effect of 0.04% chlorhexidine gluconate with hypertonic saline as a scolexicide during liver hydatid surgery and the rate of hydatid cyst recurrence.

This is a phase III randomized controlled clinical trial with parallel groups and double blinding. Patients are allocated using balanced block randomization (1:1) into two groups (total 40).

Patients with hepatic hydatid cyst referred to Shahrekord Kashani Hospital will be randomly assigned to two groups receiving either 0.04% chlorhexidine gluconate or hypertonic saline as intraoperative scolicidal agents, and 6-month recurrence of hydatid cyst will be evaluated.

Inclusion criteria 1. Patients with hepatic hydatid cysts with indications for surgery 2. Consent to participate in the study 3. Age between 18-65 years 4. There should be no contraindications for surgery Exclusion criteria: 1. Patients with severe comorbidities 2. Patients with a history of sensitivity to chlorhexidine gluconate 3. Patients with recurrent hydatid cysts 4. Patients undergoing re-surgery for hydatid cysts 5. Lack of cooperation and unwillingness to enter the study 6. Use of albendazole before surgery

All surgical procedures are the same in both groups, only the type of solution used differs. Hypertonic saline solution is used in one group and chlorhexidine solution is used in the other group.

Recurrence rates after surgery

This randomized clinical trial employs balanced block randomization with an allocation ratio of 1:1 to assign eligible patients into two intervention groups. Block randomization is used to ensure balanced group sizes throughout the recruitment period. Variable block sizes (e.g., 4 and 6) are generated randomly to prevent predictability of treatment allocation. The exact block sizes are not disclosed to the research team to minimize selection bias.

A double-blind design is implemented in this study. Blinding is maintained as follows: 1. Participants: Patients are unaware of which scolicidal solution is used during surgery. Both solutions are presented in identical, unlabeled packages. 2. Surgeons and Clinical Staff: The operating surgeon and clinical team performing patient care are blinded to group allocation. Intervention packages are prepared by an independent supervisor and identified only by coded 1 and 2 labels. 3. Data Collectors and Outcome Assessors: Data collection, form completion, and outcome evaluation (including CT scan assessment for recurrence) are performed by investigators who remain blinded to treatment allocation. 4. Data Analysts: Statistical analyses are conducted using coded group labels (Group 1 and Group 2), without revealing the actual intervention identity. 5. Study Supervisor: Only the study supervisor has access to the allocation code and does not participate in patient recruitment, treatment, data collection, or data analysis. Thus, blinding is preserved from patient enrollment through intervention delivery, outcome assessment, and statistical analysis.

Due to the single-center design, limited sample size, and to ensure confidentiality of patient information, there is no plan to share individual participant data outside the research team.

The full study protocol, informed consent form, final clinical study report, and data dictionary will be made available upon reasonable request to the corresponding investigator after completion of the study. Individual participant data will not be shared in order to protect patient confidentiality. The data dictionary includes definitions of study variables, data types, and coding structure.

Study documents will be available upon reasonable request after publication of results.

Researchers affiliated with academic and scientific institutions may request access to study documents upon reasonable request. Provision of documents will be subject to approval by the principal investigator and compliance with confidentiality principles. Individual participant data will not be shared.

Access to study documents is permitted only for scientific and academic research purposes. Any commercial use or publication without proper citation is prohibited. Secondary analyses are limited to scientific descriptive and comparative analyses and must comply with confidentiality principles. Access is subject to submission of a written request, statement of intended use, and commitment to confidentiality. Provision of documents requires approval of the principal investigator. Individual participant data will not be shared under any circumstances.

rahimi.r@skums.ac.ir

Requests will be reviewed by the principal investigator, and the requested documents will be provided as soon as possible after approval of the request.