A Trial of Single Incision Versus Four Ports Laparoscopic Cholecystectomy

Cholelithiasis Clinical Trial

Official title:

Estudio Prospectivo Aleatorizado de la colecistectomía laparoscópica Por Puerto único vs colecistectomía laparoscópica Por Cuatro Puertos en Pacientes Con Colelitiasis sintomática y régimen de cirugía Sin Ingreso.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02375529
• Other study ID #: 11/19
• Status: Completed
• Phase: N/A
• First received: November 12, 2014
• Last updated: February 24, 2015
• Start date: May 2011
• Est. completion date: July 2014

Study information

• Verified date: February 2015
• Source: Consorci Sanitari Integral
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Background: Single-incision laparoscopic cholecystectomy (SILC) is increasingly being used as a minimally invasive surgery with potential benefits over 4-port laparoscopic cholecystectomy (LC) in terms of postoperative pain and faster recovery.

Methods: Seventy-three patients with symptomatic cholelithiasis were randomized to SILC (n=37) or LC (n=36). Data measures included operative details, adverse events, postoperative pain and analgesic requirements, success of the ambulatory process, return to normal activity and return to work, cosmetic results and quality of life score.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: July 2014
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• age higher than 18 and lower than 80

• American Society of Anesthesiologists class (ASA) I-II,

• absence of any previous anesthetic complication,

• accompaniment by a responsible adult during 24 hours,

• symptomatic gallstones candidate to cholecystectomy

• and a signed informed consent.

Exclusion Criteria:

• a Body Mass Index (BMI) higher than 35,

• any laparoscopic contraindication,

• acute cholecystitis background, suspect of Mirizzi's Syndrome, common duct stones or malignancy,

• anti-inflammatory allergy

• psychiatric history that could hinder ambulatory procedure

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Gallstones

Intervention

Procedure:
• Single Incision Laparoscopic Cholecystectomy (SILC)
A 2.5-cm incision is made through the everted umbilicus down to the midline fascia, and through the fascia and the peritoneum. The multichannel port (Olympus) is introduced. Carbon dioxide is insufflated (12 mmHg) and a 30 degree 10-mm laparoscope is introduced. The operating table is put in the reverse Trendelenburg position (20 degrees), left side down. A pre-curved grasper and the monopolar electrocautery are introduced through the other 2 ports of the trocar and the dissection of the gallbladder starts in a retrograde manner. The triangle of Calot is exposed, the cystic duct and artery are separately dissected and ligated with 5 mm clips. The monopolar electrocautery is used to remove the gallbladder from the liver bed. The gallbladder is removed along with the port system from the abdominal cavity. The fascia at the port site is closed and the umbilicus is inverted.
• Four Ports Laparoscopic Cholecystectomy (4PLC)
An 11-mm periumbilical port, a 10-mm left upper quadrant port , 5mm subxyphoid port, and 5-mm right lower quadrant port were used in 4-port LC. We adopted the single surgeon technique in the 4-port LC using 30-degree operating telescopes that was inserted into the umbilical port. Retraction of the gallbladder was done by the long grasping forceps through the 5-mm right lower quadrant port, whereas dissection was accomplished through the 10-mm left upper quadrant port. The cystic duct and cystic artery were clipped by a 5-mm multiple clip applicator. The gallbladder was retrieved through the umbilical port after the position of the operating telescope was changed. Nontransparent surgical adhesive tape was applied to the standard 4-port sites at the end of the operation .

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Consorci Sanitari Integral

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	evolution of postoperative pain		2, 4, 6 and 8 postoperative hours, 1, 3, 7 and 30 days after surgery	Yes