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Completed

NCT Number: NCT02375529

A Trial of Single Incision Versus Four Ports Laparoscopic Cholecystectomy

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Single Incision Laparoscopic Cholecystectomy (SILC)

Procedure

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)

Procedure

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 .

Primary outcomes

  1. evolution of postoperative pain

    Time frame: 2, 4, 6 and 8 postoperative hours, 1, 3, 7 and 30 days after surgery

Sponsors and collaborators

Lead sponsor

Consorci Sanitari Integral

Other

Registry information

Official study 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.

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Mar 2, 2015
Registry last updated
Mar 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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