Clinical trial NCT06708390: Single-Incision Laparoscopic Cholecystectomy with Inflexible Laparoscopic Instruments and Laparoscopy: a Single-Center Experience
Official title: Single-Incision Laparoscopic Cholecystectomy with Inflexible Laparoscopic Instruments and Laparoscopy: a Single-Center Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Benign Gallbladder Disease
Keywords: single-incision laparoscopic
laparoscopic cholecystectomy
cholecystolithiasis
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2024-11-27
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with benign gallbladder diseases

Brief summary: Since being introduced by Mühe in 1985, laparoscopic cholecystectomy (LC) has garnered global acceptance and defined as gold standard treatment for benign gallbladder diseases (BGDs). Minimally invasive surgery technique was applied in a spectrum of surgeries including LC, namely single-incision laparoscopic cholecystectomy (SILC), initially reported by Navarra in 1997. By then this technique developed dramatically in aspects of both operation and instruments. Previous experiences with SILC across various centers have consistently demonstrated its robust safety and feasibility. Numerous clinical trials have highlighted the benefits of SILC over conventional laparoscopic cholecystectomy (CLC), particularly in terms of promoted aesthetic outcomes, reduced postoperative pain, and shorter hospital stays.However, discrepancies in postoperative complications including incisional hernias have sparked debate regarding the merits and drawbacks of SILC. Consequently, further research is urgent with larger cohorts and extended postoperative follow-up periods for a definitive assessment of SILC.

In the present study LC was performed in cases from January 2023 to March 2024, aiming to compare the overall outcomes and complications between CLC and SILC. All surgical instruments and laparoscopy were introduced through a single intraumbilical incision in SILC group, allowing the resultant scar to be discreetly concealed within the reconstructed navel. Furthermore, historical implementations of SILC have predominantly utilized specialized and novel instruments. This reliance on special equipment limited the technique's applicability and benefits in settings with more rudimentary clinical facilities. The authors successfully applied conventional laparoscopic instruments and a 10mm laparoscopy with straight and inflexible properties and simplified the surgical process. Moreover, the single-incision port used were made on site from basic stuffs and materials easily obtained from operation room.


Eligibility criteria: Inclusion Criteria:

* Gallbladder stone；
* Acute cholecystitis；
* Chronic cholecystitis；
* Gallbladder adenomyomatosis；
* Gallbladder polyp.

Exclusion Criteria:

* Combined with liver cirrhosis (Child grade B and above)；
* Gallbladder gangrene perforation;
* Changes in surgical plan (conversion to laparotomy,cholangiography, bile duct exploration, bile duct injury repair, abscess clearance, multivisceral resection.);
* patients and their families do not agree with the treatment lost follow-up.

Primary outcomes:
measure: Postoperative complications
timeFrame: Six months postoperatively
Secondary outcomes:
measure: Postoperative quality of life
timeFrame: Six months postoperatively
measure: Scar assessment
timeFrame: One month postoperatively
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
state: Zhejiang
Study officials:
affiliation: Chief Physician
name: Daren Liu, MD, PhD
role: STUDY_DIRECTOR
References: