Surgical Techniques: Robotic Versus Conventional Laparoscopic Cholecystectomy IN Benign Gallbladder Disease

The incidence (%) of postoperative complications occurring within 30 days after surgery in patients with benign gallbladder disease. The outcome compares the total number of complications between patients treated with robotic cholecystectomy (RC) and those treated with laparoscopic cholecystectomy (LC).

Complication severity will be graded using the Clavien-Dindo classification:

• Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions.
• Requiring pharmacological treatment with drugs other than such allowed for grade I complications.

Blood transfusions and total parenteral nutrition are also included.

• Requiring surgical, endoscopic or radiological intervention i. intervention not under general anaesthesia ii. intervention under general anaesthesia
• Life-threatening complication (including central nervous system complications), requiring management in an Intensive Care Unit (ICU).
• Death of a patient

The frequency (%) of individual postoperative complications occurring within 30 days following surgery in patients undergoing cholecystectomy.

The Comprehensive Complication Index (CCI) is a validated score based on the Clavien-Dindo classification system that quantifies all postoperative complications occurring within 30 days after surgery. The score ranges from 0 (no complications) to 100 (death), reflecting the cumulative burden of morbidity per patient.

Two time intervals will be recorded to assess procedure duration and robotic set-up times:

Total time spent in the operating theatre, measured as the time from patient arrival (hh:mm) to exit (hh:mm).

Actual surgical time, measured as the time from skin incision ("knife to skin") to skin closure (hh:mm).

Times will be recorded in minutes.

Peri-operative blood loss will be measured quantitatively in millilitres. Additionally, the number of tonsil swabs used during the procedure will be recorded as a qualitative indicator of blood loss.

Intra-abdominal pressure will be continuously measured in millimeters of mercury (mmHg) during insufflation throughout the surgical procedure.

The percentage (%) of surgical procedures in which perforation of the gallbladder occurs intraoperatively.

Percentage (%) of patients experiencing any intraoperative complication during surgery.

Technical difficulty of the procedure is graded as per Nassar et al.:

Grade 1: Gallbladder-floppy, non-adherent; Cystic pedicle-thin and clear; Adhesions-Simple up to the neck/Hartmann's pouch Grade 2: Gallbladder-Mucocele, Packed with stones; Cystic pedicle-Fat laden; Adhesions-Simple up to the body Grade 3: Gallbladder-Deep fossa, Acute cholecystitis, Contracted, Fibrosis, Hartmann's adherent to common bile duct (CBD), Impaction; Cystic pedicle-Abnormal anatomy or cystic duct-short, dilated or obscured; Adhesions-Dense up to fundus; Involving hepatic flexure or duodenum Grade 4: Gallbladder-Completely obscured, Empyema, Gangrene, Mass; Cystic pedicle-Impossible to clarify; Adhesions-Dense, fibrosis, wrapping the gallbladder, Duodenum or hepatic flexure difficult to separate

Intraoperative assessment of the liver parenchyma, classified into one of the following categories based on visual and tactile evaluation by the surgeon: normal, enlarged, steatotic, or cirrhotic.

Percentage (%) of surgical procedures during which imaging-based assessment of the common bile duct (CBD) was performed. Assessment is defined as the use of on-table cholangiogram (OTC) or intraoperative ultrasound (IOUSS) for visualization of the CBD.

Among patients in whom gallstones were identified in the common bile duct (CBD) during intraoperative assessment, the percentage (%) of cases in which CBD exploration was performed.

According to current guidelines, prophylactic antibiotics are not routinely indicated. Any deviations, including type, dose, and timing of antibiotics given during surgery, will be recorded

Documentation of whether one or more surgical drains were placed intraoperatively. In cases with multiple drains, the total number of drains placed will be recorded.

Surgical perceived effort during the procedure will be assessed using the Surgical Task Load Index (SURG TLX), a surgical-specific adaptation of the NASA-TLX. The index evaluates six dimensions-mental demands, physical demands, temporal demands, task complexity, situational stress, and distractions-each rated on a 0 to 20 scale (0 = low, 20 = high). Scores will be collected from the operating surgeon immediately after the procedure.

Amount and type of analgesia administered to the patient in the post-anesthesia care unit (recovery room) from arrival until discharge from recovery. Data includes all analgesic medications given and their dosages.

Documentation of whether opioids were prescribed at the time of hospital discharge, including type, dose, and quantity.

Percentage (%) of patients discharged from the hospital on the same calendar day as their surgical procedure.

Duration in minutes from the patient's departure from the operating theatre to arrival in stage 3 recovery.

Percentage (%) of patients who are readmitted to the hospital for any cause within 30 days following surgery.

Percentage (%) of patients requiring any additional medical or surgical interventions within 30 days following cholecystectomy.

The EQ-5D-5L is a standardized patient-reported questionnaire measuring health-related quality of life. It consists of a descriptive system assessing five dimensions-mobility, self-care, usual activities, pain/discomfort, and anxiety/depression-with five severity levels each, ranging from no problems to extreme problems. Additionally, it includes a Visual Analogue Scale (EQ VAS), ranging from 0 (worst imaginable health) to 100 (best imaginable health), on which patients rate their overall health. Higher EQ-5D-5L index scores and EQ VAS scores indicate better health-related quality of life.

The Otago Condition-Specific Questionnaire (O-CSQ) is a validated patient-reported questionnaire assessing gallstone-specific quality of life. It encompasses four domains: Physical Functioning (pain, dyspepsia, diet changes), Systemic Functioning (fatigue), Social Functioning (daily duties, leisure, relationships), and Emotional Functioning (mood). The O-CSQ consists of 12 items, each scored on a 5-point Likert scale (1 = no symptom burden, 5 = highest symptom burden). Higher total scores indicate a higher symptom burden and therefore poorer quality of life.

The Quality of Recovery 15 (QoR-15) questionnaire assesses postoperative recovery across five dimensions: pain, physical comfort, physical independence, emotional status, and psychological support. It consists of 15 items rated on an 11-point scale from 0 to 10. The total QoR-15 score ranges from 0 to 150, with higher scores indicating better quality of recovery.

To assess the impact of implementing robotic cholecystectomy (RC) on hospital costs, case data will be collected and compared between the RC and laparoscopic cholecystectomy (LC) groups. This includes operative costs, admission costs, and additional treatment costs (total healthcare utilization) from the index operation up to 30 days postoperatively.