NCT01772745

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2010

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 21, 2013

Completed
Last Updated

January 21, 2013

Status Verified

January 1, 2013

Enrollment Period

3 years

First QC Date

January 16, 2013

Last Update Submit

January 17, 2013

Conditions

Gallbladder Disease

Keywords

single incisioncholecystectomylaparoscopy

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (1)

  • Operating time

    Average of 70 minutes

Other Outcomes (2)

  • Length of hospital stay

    Average of 2 days

  • Postoperative complications

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

Study Arms (2)

Group 1

ACTIVE COMPARATOR

SILS cholecystectomy

Procedure: SILS cholecystectomy

Group 2

ACTIVE COMPARATOR

TPCL cholecystectomy

Procedure: TPCL cholecystectomy

Interventions

SILS cholecystectomyPROCEDURE

Single incision laparoscopic cholecystectomy will be performed

Group 1
TPCL cholecystectomyPROCEDURE

Three port laparoscopic cholecystectomy will br performed

Group 2

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Required laparoscopic cholecystectomy for gallbladder disease.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Deveci U, Barbaros U, Kapakli MS, Manukyan MN, Simsek S, Kebudi A, Mercan S. The comparison of single incision laparoscopic cholecystectomy and three port laparoscopic cholecystectomy: prospective randomized study. J Korean Surg Soc. 2013 Dec;85(6):275-82. doi: 10.4174/jkss.2013.85.6.275. Epub 2013 Nov 26.

    PMID: 24368985DERIVED

MeSH Terms

Conditions

Gallbladder Diseases

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System Diseases

Study Officials

  • Uğur Deveci, Ass. Prof.

    Maltepe University, School of Medicine , General Surgery Department

    PRINCIPAL INVESTIGATOR

  • Manuk N. Manukyan, Ass.Prof.

    Maltepe University, School of Medicine, General Surgery Department

    STUDY DIRECTOR

  • Umut Barbaros, Ass.Prof.

    Istanbul University, Istanbul Medical School, General Surgery Department

    PRINCIPAL INVESTIGATOR

  • Abut Kebudi, Prof.

    Maltepe University, School of Medicine, General Surgery Department

    STUDY CHAIR

  • Sertan Kapakli, Ass.Prof.

    Maltepe University, School of Medicine, General Surgery Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass.Prof.

Study Record Dates

First Submitted

January 16, 2013

First Posted

January 21, 2013

Study Start

January 1, 2010

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

January 21, 2013

Record last verified: 2013-01