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Prospective randomized double-blind clinical study of modified single-hole laparoscopic cholecystectomy versus conventional single-hole laparoscopic cholecystectomy

Prospective randomized double-blind clinical study of modified single-hole laparoscopic cholecystectomy versus conventional single-hole laparoscopic cholecystectomy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085182
Enrollment
Unknown
Registered
2024-06-03
Start date
2024-06-05
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gallbladder disease

Interventions

Experimental group :Experimental group underwent conventional single-hole laparoscopic cholecystectomy
control group:Control group underwent modified single-hole laparoscopic cholecystectomy

Sponsors

The Eighth Affiliated Hospital, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Preoperative diagnosis of gallstones with chronic cholecystitis, acute cholecystitis, gallbladder polyps, gallbladder adenomyosis and other benign gallbladder diseases by two or more imaging methods; 2) Signed informed consent to be enrolled in the clinical trial.

Exclusion criteria

Exclusion criteria: 1) Previous history of abdominal surgery, 2) patients with gallbladder malignancy not excluded by preoperative imaging, 3) patients with gallbladder malignancy confirmed by postoperative pathology, 4) patients who switched to traditional three-hole laparoscopic cholecystectomy during the operation, 5) clinical investigators were refused to be enrolled.

Design outcomes

Primary

MeasureTime frame
The postoperative results included body image score and scar evaluation at 12 weeks after surgery;

Secondary

MeasureTime frame
Intraoperative blood loss;Operation time;Cases of conversion to traditional three-hole laparoscopy/total cases;The completion rate of safety-critical surgical fields during the operation;The surgeon's assessment;Wound satisfaction score;

Countries

China

Contacts

Public ContactZheng Zhou

The Eighth Affiliated Hospital, Sun Yat-sen University

zhouzh76@mail.sysu.edu.cn+86 138 2843 4680

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026