Gallbladder retractor and Knot pusher with simultaneous coaxial traction : new laparoscopic instruments.

Gallbladder retractor and Knot pusher with simultaneous coaxial traction: new laparoscopic instruments for minilaparoscopic cholecystectomy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000019

Enrollment

Unknown

Registered

2008-07-29

Start date

2000-11-30

Completion date

Unknown

Last updated

2026-08-10

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

Conditions

Symptomatic chronic cholelithiasis

Interventions

All patients in both groups were operated on by the same experienced laparoscopic surgeon. A similar general anesthesia technique was followed in all cases. After pneumoperitoneum and initial laparosc

Cholecystectomy, Laparoscopic

Pneumoperitoneum, Artificial

Cholecystectomy

Laparoscopy

Gallbladder retractor, Knot pusher with simultaneous coaxial traction

Eligibility

Sex/Gender

All

Age

15 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients older than 15 years-old, both gender, with diagnosis of symptomatic chronic cholelithiasis tributary of surgical treatment.

Exclusion criteria

Exclusion criteria: PREOPERATIVE: -History of acute cholecystitis -History of cholangitis or bile duct calculus -History of pancreatitis -Hepatic cirrhosis associated -Morbid obesity -Acute cholecystitis -Clinical, chemical and/or echographic criteria for intraoperative cholangiographie -An added proposed surgical procedure DURING INITIAL LAPAROEXPLORATION: -Cancer of gallbladder -Severe inflammation of gallbladder -Extensive adhesions in abdominal right quadrant

Design outcomes

Primary

Measure	Time frame
1-“Gallbladder’s fundus retraction”, timepoint: at the end of surgical procedure. Asses the efficacy of GR as retraction device for vesicular fundus. 2-“Placement of endo-loops sutures”, timepoint: at the end of surgical procedure. Asses the efficacy of KP to place endo-loops sutures to retract and expose the neck of gallbladder. 3-“Sliding of endo-loops sutures”, timepoint: at the end of surgical procedure. Asses the efficacy of KP, because it has influence on adequate surgical technique. 4- “Success on the technique of cholecystectomy proposed”, timepoint: at the end of surgical procedure. Asses the general efficacy of both instruments.	—

Measure

Time frame

1-“Gallbladder’s fundus retraction”, timepoint: at the end of surgical procedure. Asses the efficacy of GR as retraction device for vesicular fundus. 2-“Placement of endo-loops sutures”, timepoint: at the end of surgical procedure. Asses the efficacy of KP to place endo-loops sutures to retract and expose the neck of gallbladder. 3-“Sliding of endo-loops sutures”, timepoint: at the end of surgical procedure. Asses the efficacy of KP, because it has influence on adequate surgical technique. 4- “Success on the technique of cholecystectomy proposed”, timepoint: at the end of surgical procedure. Asses the general efficacy of both instruments.

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Secondary

Measure	Time frame
- “Operative time”, timepoint: at the end of surgical procedure. - “CO2 consumption”, timepoint: at the end of surgical procedure. - “Adverse events related to the use of designed instruments”, timepoint: at the end of surgical procedure. - “Cosmetic results”, timepoint: at the follow-up, on 10-15 days before surgical procedure. - “Cost of surgical procedure”, timepoint: at the end of hospital stay.	—

Measure

Time frame

- “Operative time”, timepoint: at the end of surgical procedure. - “CO2 consumption”, timepoint: at the end of surgical procedure. - “Adverse events related to the use of designed instruments”, timepoint: at the end of surgical procedure. - “Cosmetic results”, timepoint: at the follow-up, on 10-15 days before surgical procedure. - “Cost of surgical procedure”, timepoint: at the end of hospital stay.

—

Countries

Cuba

Contacts

Public ContactRafael Torres Peña

National Center for Minimal Access Surgery

torres@cce.sld.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Aug 15, 2026