The Comparison of Single Incision Laparoscopic Cholecystectomy and Three Port Laparoscopic Cholecystectomy

Gallbladder Disease Clinical Trial

Official title:

The Comparison of Single Incision Laparoscopic Cholecystectomy and Three Port Laparoscopic Cholecystectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01772745
• Other study ID #: mütf3
• Status: Completed
• Phase: N/A
• First received: January 16, 2013
• Last updated: January 17, 2013
• Start date: January 2010
• Est. completion date: January 2013

Study information

• Verified date: January 2013
• Source: Maltepe University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Laparoscopic techniques have allowed surgeons to perform complicated intrabdominal surgery with minimal trauma. Laparoscopic cholecystectomy has been recognized since 1987 as the gold standard procedure for gallbladder surgery. Single incision laparoscopic surgery (SILS) was developed with the aim of reducing the invasiveness of conventional laparoscopy. In this study we aimed to compare results of SILS cholecystectomy and three port conventional laparoscopic (TPCL) cholecystectomy prospectively

Description:

Single-incision laparoscopic procedures have evolved gradually to include a multitude of various surgeries. The current literature documents the use of a single-incision or single-port access surgery for cholecystectomies, adrenalectomies, splenectomies, appendectomies, herniorrhaphies, bariatrics, and colon surgery.

Total of 100 patients who undergoing laparoscopic cholecystectomy for gallbladder disorders will randomly assign to undergo SILS cholecystectomy group (n = 50) or TPCL cholecystectomy group (n= 50) according to a computer-generated table of random numbers. Demographics (ie, age, gender, body mass index (BMI), American Society of Anesthesiology (ASA) score, indication for operation, need for conversion to a standard or three port laparoscopic cholecystectomy, need for conversion to an open cholecystectomy will be recorded. Outcome measures include operative morbidity, operative time, pain score, hospital stay. Morbidity will be evaluated by rates of bile leak, wound infection, hospital readmission, and hernia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Required laparoscopic cholecystectomy for gallbladder disease.

Exclusion Criteria:

• American Society of Anesthesiologists score (ASA) more than III,

• Patients had prior abdominal surgery,

• Patients admitted outside working hours with acute cholecystitis,

• Patients have choledocolithiasis,

• pregnancy,

• ongoing peritoneal dialysis,

• lack of written informed consent.

Study Design

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

Related Conditions & MeSH terms

• Gallbladder Disease
• Gallbladder Diseases

Intervention

Procedure:
• SILS cholecystectomy
Single incision laparoscopic cholecystectomy will be performed
• TPCL cholecystectomy
Three port laparoscopic cholecystectomy will br performed

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Maltepe University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Length of hospital stay	Length of hospital stay will be recorded postoperative period.	Average of 2 days	No
Other	Postoperative complications	Postoperative complications will be recorded postoperative follow up.; Bleeding; Bile leakage; Intrabdominal injury; Wound infection; Port site hernia	24th hour, 2nd day, 3rd day, 7th day, 1st month, 3rd month, 6th month, 1st year	Yes
Primary	pain score	Postoperative pain will be assessed according Visual analog scale from 0 (no pain) to 10 (worst pain imaginable. Postoperative six hour VAS (POSH-VAS) and postoperative first day VAS (POFD-VAS) will be recorded and compared.	Postoperative first 24 hours	No
Primary	Intraoperative complications	Per operative complications will be recorded.; Bleeding; Gallbladder perforation; Bile leakage; Bowel perforation; Complications associated with increased intra-abdominal pressure	Average of 70 minutes	Yes
Secondary	Operating time	The operating time will be defined as the time from the first incision to the last suture's placement.	Average of 70 minutes	No