Comparison of "Pick'n Roll" Single-incision Laparoscopic Cholecystectomy Technique, and Laparoscopic Cholecystectomy
NCT02149797 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2014-05-29
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
Interventions
- PROCEDURE
-
Four port laparoscopic cholecystectomy
Classical four port laparoscopic cholecystectomy
- PROCEDURE
-
SILC-Pick'n roll-Beginning (group I)
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
- PROCEDURE
-
SILC-Pick'n roll-Experienced (group II)
Similar technique of SILC-Pick'n roll-Beginning (group I) was used
Sponsors & Collaborators
-
Samsun Education and Research Hospital
lead OTHER
Principal Investigators
-
Recep Aktimur · Samsun Education and Research Hospital, Samsun, Turkey
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-01-31
- Primary Completion
- 2014-04-30
- Completion
- 2014-04-30
Countries
- Turkey (Türkiye)
Study Locations
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