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

Primary Purpose

Gallbladder Disease

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

SILS cholecystectomy

TPCL cholecystectomy

About this trial

This is an interventional treatment trial for Gallbladder Disease focused on measuring single incision, cholecystectomy, laparoscopy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

SILS cholecystectomy

TPCL cholecystectomy

Outcomes

Primary Outcome Measures

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.

Intraoperative complications

Per operative complications will be recorded. Bleeding Gallbladder perforation Bile leakage Bowel perforation Complications associated with increased intra-abdominal pressure

Secondary Outcome Measures

Operating time

The operating time will be defined as the time from the first incision to the last suture's placement.

Full Information

NCT ID

NCT01772745

First Posted

January 16, 2013

Last Updated

January 17, 2013

Sponsor

Maltepe University

1. Study Identification

Unique Protocol Identification Number

NCT01772745

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

January 2013 (Actual)

Study Completion Date

January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Maltepe University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gallbladder Disease

Keywords

single incision, cholecystectomy, laparoscopy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Active Comparator

Arm Description

SILS cholecystectomy

Arm Title

Group 2

Arm Type

Active Comparator

Arm Description

TPCL cholecystectomy

Intervention Type

Procedure

Intervention Name(s)

SILS cholecystectomy

Intervention Description

Single incision laparoscopic cholecystectomy will be performed

Intervention Type

Procedure

Intervention Name(s)

TPCL cholecystectomy

Intervention Description

Three port laparoscopic cholecystectomy will br performed

Primary Outcome Measure Information:

Title

pain score

Description

Time Frame

Postoperative first 24 hours

Title

Intraoperative complications

Description

Per operative complications will be recorded. Bleeding Gallbladder perforation Bile leakage Bowel perforation Complications associated with increased intra-abdominal pressure

Time Frame

Average of 70 minutes

Secondary Outcome Measure Information:

Title

Operating time

Description

The operating time will be defined as the time from the first incision to the last suture's placement.

Time Frame

Average of 70 minutes

Other Pre-specified Outcome Measures:

Title

Length of hospital stay

Description

Length of hospital stay will be recorded postoperative period.

Time Frame

Average of 2 days

Title

Postoperative complications

Description

Postoperative complications will be recorded postoperative follow up. Bleeding Bile leakage Intrabdominal injury Wound infection Port site hernia

Time Frame

24th hour, 2nd day, 3rd day, 7th day, 1st month, 3rd month, 6th month, 1st year

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials: