Surgical and Postoperative Outcomes of Three-Port Versus Four-Port Laparoscopic Cholecystectomy: A Randomized Controlled Trial Protocol

A comparative assessment of operative duration, postoperative pain, analgesic requirements, recovery, and complications following laparoscopic cholecystectomy.

Abstract

Background: Laparoscopic cholecystectomy is widely used to manage symptomatic gallstone disease. Reducing the number of ports from four to three has been proposed as a way to reduce postoperative discomfort and support recovery, while maintaining procedural safety.

Objective: To compare surgical and postoperative outcomes between three-port and conventional four-port laparoscopic cholecystectomy.

Methods: This protocol describes a randomized controlled trial with a planned sample of 60 patients aged 25–60 years, allocated equally to three-port laparoscopic cholecystectomy (Group A) or four-port laparoscopic cholecystectomy (Group B). Consecutive eligible patients will be recruited, and group allocation will be performed using a lottery method with sealed opaque envelopes. The planned study duration is six months after synopsis approval.

Outcomes: The study will document operative duration, intraoperative blood loss, common bile duct injury, conversion to open surgery, postoperative pain at 24 hours, duration of oral analgesia, time to return to routine activities, and surgical wound infection through 30 days.

Conclusion: The study is intended to provide local comparative evidence about recovery and safety outcomes associated with three-port versus four-port laparoscopic cholecystectomy. Results are not yet available because this is a research protocol.

Keywords

Keywords: Three-port laparoscopic cholecystectomy; four-port laparoscopic cholecystectomy; postoperative pain; oral analgesia; operative duration; surgical outcomes; randomized controlled trial.

Introduction

Laparoscopic cholecystectomy is an established operative treatment for symptomatic gallstone disease. Since its introduction, refinements in technique have aimed to improve cosmetic outcomes, reduce postoperative discomfort, shorten hospital stay, and limit healthcare costs while preserving safety. One approach is to reduce the number of ports used during surgery from the conventional four-port technique to a three-port technique.

In the conventional approach, a fourth port can provide additional traction and exposure of the gallbladder. The three-port technique omits this additional port and may reduce abdominal wall access sites. However, the effect of using fewer ports can depend on patient characteristics, the difficulty of the procedure, and the operating surgeon’s experience. Technical feasibility and careful dissection remain important considerations.

Studies comparing three-port and four-port laparoscopic cholecystectomy have reported outcomes involving postoperative pain, analgesic use, recovery, operative duration, and complications. The synopsis cites research suggesting that fewer ports may be associated with lower postoperative pain scores and reduced analgesic requirements, while rates of complications such as wound infection and common bile duct injury require careful evaluation [5–9]. Findings from local clinical settings can help determine whether the three-port approach is suitable for routine practice.

The present study is designed to compare surgical and postoperative outcomes between three-port and conventional four-port laparoscopic cholecystectomy in eligible patients with acute cholecystitis. The planned assessment includes operative and recovery measures as well as complications, with the aim of informing evidence-based surgical decision-making.

Study Objective

To compare surgical and postoperative outcomes between three-port and conventional four-port laparoscopic cholecystectomy.

Hypothesis

The duration of oral analgesia required after three-port laparoscopic cholecystectomy will be lower than that required after four-port laparoscopic cholecystectomy.

Operational Definitions and Study Outcomes

Acute cholecystitis: Patients with right upper quadrant pain (visual analogue scale greater than 3), fever (temperature at least 100°F), and a positive Murphy’s sign, together with sonographic evidence such as gallstones, gallbladder wall thickening, or pericholecystic fluid, will be classified as having acute cholecystitis.

Obesity: A body mass index (BMI) greater than 30 kg/m² will be considered obesity. BMI will be calculated as weight in kilograms divided by height in metres squared.

Duration of surgery: The time in minutes from skin incision to skin closure.

Common bile duct injury: Iatrogenic injury identified during surgery or within 30 postoperative days and supported by operative findings or postoperative imaging, as specified in the synopsis.

Conversion to open surgery: Conversion from laparoscopic to open cholecystectomy, documented from the operative notes.

Postoperative pain: Pain measured 24 hours after surgery using a 0–10 visual analogue scale, where 0 indicates no pain and 10 indicates the most severe pain.

Duration of oral analgesia: The number of days for which oral analgesics are required to control pain with a VAS score greater than 3.

Return to normal activity: The number of days from hospital discharge until resumption of usual daily activities.

Surgical wound infection: Wound infection assessed through 30 days after surgery, as recorded during follow-up.

Materials and Methods

Study design: Randomized controlled trial.

Study setting: General surgery department.

Study duration: Six months after approval of the research synopsis.

Sample size: A total of 60 patients, with 30 participants in each group. The synopsis reports that the sample size was calculated using OpenEpi for a difference between means, based on oral analgesia duration of 3.5 ± 0.55 days in the three-port group and 4.6 ± 0.92 days in the four-port group, with 80% power and a 95% confidence level.

Sampling technique: Non-probability consecutive sampling, followed by random allocation to the study groups.

Inclusion criteria: Male and female patients aged 25–60 years, presenting with features of acute cholecystitis as defined in the protocol, with symptom duration of seven days or less and planned for laparoscopic cholecystectomy.

Exclusion criteria: Pregnancy; choledocholithiasis; common bile duct dilatation greater than approximately 6–7 mm; acute cholangitis; gallbladder empyema or perforation; generalized peritonitis; abdominal surgery within the previous three months; uncontrolled coagulopathy (INR greater than 1.5); gallbladder carcinoma diagnosed on CT; or chronic liver disease documented by history or medical record.

Group allocation: After ethics review approval and informed consent, eligible patients will be assigned to Group A (three-port laparoscopic cholecystectomy) or Group B (four-port laparoscopic cholecystectomy). The synopsis specifies a lottery method using sealed opaque envelopes containing a slip marked A or B.

Surgical procedure and follow-up: Procedures will be performed by an experienced consultant surgeon with at least five years of post-fellowship experience and expertise in both techniques. Standard institutional protocols will be followed. Postoperatively, patients will receive care according to the treating team’s protocol. Pain will be assessed at 24 hours, duration of oral analgesia and time to resume usual activities will be recorded at day 7, and wound infection and late evidence of common bile duct injury will be assessed through day 30.

Data collection: Demographic and clinical variables will include age, sex, BMI, obesity status, ASA status, diabetes, hypertension, duration of symptoms, and relevant operative findings. Operative duration, intraoperative blood loss, common bile duct injury, conversion to open surgery, postoperative pain, analgesic duration, return to routine activity, and wound infection will be documented on the study proforma.

Statistical Analysis

Data will be analyzed using SPSS version 23. Normality of quantitative data will be assessed with the Shapiro–Wilk test. Normally distributed continuous variables will be summarized as mean and standard deviation; median and interquartile range will be used for variables that are not normally distributed. Categorical variables will be reported as frequencies and percentages.

Between-group comparisons for quantitative outcomes will use the independent-samples t-test, with the chi-square test used for categorical outcomes. The synopsis also proposes stratification by age group, sex, obesity, ASA status, diabetes, hypertension, and duration of symptoms to assess their influence on outcomes. A p-value below 0.05 will be considered statistically significant.

Expected Outcomes and Utilization

The protocol anticipates that the three-port approach may be associated with lower postoperative pain, a shorter duration of oral analgesia, and earlier return to normal daily activities. The study will also examine whether differences in these outcomes occur without a higher frequency of complications, including common bile duct injury, wound infection, or conversion to open surgery.

The findings may help surgeons evaluate the practical benefits and safety of reducing the number of ports used during laparoscopic cholecystectomy. They may also inform local clinical decision-making, postoperative recovery planning, resource use, and the design of future studies. These are expected uses of the results, not findings established by the protocol.

Ethics and Participant Protection

The synopsis states that the study will proceed after approval from the ethics review committee and the relevant research authority. Written informed consent will be obtained from eligible participants before enrolment. Study information should be handled confidentially and used for the stated research purpose.

Study Timeline

The planned total duration is six months after synopsis approval. The synopsis schedule allocates the initial period to approval and preparation, the middle months to recruitment and data collection, and the final month to data cleaning, statistical analysis, interpretation, report writing, and dissemination.

References

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Website Tags

FCPS, Laparoscopic Cholecystectomy, Three-Port Surgery, Four-Port Surgery, Postoperative Pain, Surgical Outcomes, Randomized Controlled Trial, Gallstone Disease, Recovery