Comparison of "Pick'n Roll" Single-incision Laparoscopic Cholecystectomy Technique, and Laparoscopic Cholecystectomy

NCT02149797 | Completed DMC

• 1 other identifier: SILC-PR vs. LC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Cholecystectomy is one of the most common operation performed by general surgeons. Since, first video-laparoscopic cholecystectomy in 1987, laparoscopic cholecystectomy (LC) has become the gold standard treatment for benign biliary disease. In daily practice, LC has increased general surgeons familiarity to video-laparoscopic operations and has become the first step to search more minimally invasive techniques and to perform advanced laparoscopic operations. In order to move forward the minimal invasive surgery concept with less surgical trauma and better cosmetic results, surgeons firstly reduced the number of incision and ports, then the idea of totally eliminating skin incisions through the use of natural orifices was implemented in selected cases. In theory, minimal incision must provide minimal postoperative pain and better cosmetic results. With the use of single-incision laparoscopic cholecystectomy (SILC), this purpose is achieved by means of cosmesis but providing minimal postoperative pain is still controversial. Recent reports on, LC vs. SILC showed significantly favorable cosmetic benefit, comparable complication rate and hospital stay with SILC, but the mean operation time was significantly longer. Today, lack of standardized operation technique, the need for specialized instruments, the fear of inability to apply safe cholecystectomy principles, longer operation time, cost-effectivity and advanced laparoscopic experience are still limiting factor to performing SILC. The aim of this prospective randomized controlled trial is to compare gold standard LC and SILC using our new technique called "Pick'n roll" (SILC-PR). Our goal was to provide critical view of safety and safe cholecystectomy principles on SILC, improve operator ergonomics and shorten operation time while eliminating the need for specialized instruments.

Conditions

Cholelithiasis

Outcome Measures

Primary Outcomes (1)

• Operation time

  Up to 1.5 hours

Secondary Outcomes (5)

• Conversion to open or classical laparoscopic cholecystectomy

  Up to 1.5 hours

• Insertion of additional port/ports.

  Up to 1.5 hours

• Intraoperative complication

  Up to 1.5 hours

• Lenght of hospital stay

  Up to 3 days

• Postoperative complication rate

  Up to 1 month

Study Arms (3)

Four port laparoscopic cholecystectomy

ACTIVE COMPARATOR

This group of patients undergone classical four port laparoscopic cholecystectomy

Procedure: Four port laparoscopic cholecystectomy

SILC-Pick'n roll-Beginning (group I)

ACTIVE COMPARATOR

This group of patients undergone single-incision laparoscopic cholecystectomy using our new technique called "Pick'n roll", this group was designed new intervention's beginning arm.

Procedure: SILC-Pick'n roll-Beginning (group I)

SILC-Pick'n roll-Experienced (group II)

ACTIVE COMPARATOR

This group of patients undergone single-incision laparoscopic cholecystectomy using our new technique called "Pick'n roll", this group was designed new intervention's experienced arm.

Procedure: SILC-Pick'n roll-Experienced (group II)

Interventions

Four port laparoscopic cholecystectomy PROCEDURE

Classical four port laparoscopic cholecystectomy

Four port laparoscopic cholecystectomy

SILC-Pick'n roll-Beginning (group I) PROCEDURE

SILC-PR was performed by the intraumbilical single port technique. A 10-mm, 30º scope was used. The surgeon was elevated gallbladder fundus with left hand using grasper in whole operation. If required, infindibulum was freed with monopolar hook. A 2.0 straight needle was inserted through the right of the falciform ligament, grasped with a laparoscopic needleholder using by surgeon's right hand, and passed through the Hartmann's pouch at the lowest point. To allow free manipulation, the passing suture with needle was turned around the suture to form a "half-knot". The needle was passed back out from the right of the midclavicular line. An assistant was grasped two ends of the suture and with the help of right or left hand dominant pulling tension, critical view of safety was provided

SILC-Pick'n roll-Beginning (group I)

SILC-Pick'n roll-Experienced (group II) PROCEDURE

Similar technique of SILC-Pick'n roll-Beginning (group I) was used

SILC-Pick'n roll-Experienced (group II)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic cholelithiasis

You may not qualify if:

• Acute cholecystitis (diagnosed on ultrasound or elevated inflammatory serum markers)
• Choledocholithiasis
• Less than 18 years old
• American Society of Anesthesiologist (ASA) grade IV or V.

Sponsors & Collaborators

• Samsun Education and Research Hospital: lead

Study Sites (1)

Samsun Education and Research Hospital, Department of General Surgery, Samsun, Turkey

Samsun, 55200, Turkey (Türkiye)

Location

Related Publications (3)

• Sajid MS, Ladwa N, Kalra L, Hutson KK, Singh KK, Sayegh M. Single-incision laparoscopic cholecystectomy versus conventional laparoscopic cholecystectomy: meta-analysis and systematic review of randomized controlled trials. World J Surg. 2012 Nov;36(11):2644-53. doi: 10.1007/s00268-012-1719-5.

  PMID: 22855214 BACKGROUND

• Philipp SR, Miedema BW, Thaler K. Single-incision laparoscopic cholecystectomy using conventional instruments: early experience in comparison with the gold standard. J Am Coll Surg. 2009 Nov;209(5):632-7. doi: 10.1016/j.jamcollsurg.2009.07.020. Epub 2009 Sep 11.

  PMID: 19854405 BACKGROUND

• Lai EC, Yang GP, Tang CN, Yih PC, Chan OC, Li MK. Prospective randomized comparative study of single incision laparoscopic cholecystectomy versus conventional four-port laparoscopic cholecystectomy. Am J Surg. 2011 Sep;202(3):254-8. doi: 10.1016/j.amjsurg.2010.12.009.

  PMID: 21871979 BACKGROUND

MeSH Terms

Conditions

Cholelithiasis

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Recep Aktimur

  Samsun Education and Research Hospital, Samsun, Turkey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 21, 2014
• First Posted: May 29, 2014
• Study Start: January 1, 2014
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: May 29, 2014

Record last verified: 2014-05

Locations

TU (1)