Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03433209 |
| Other study ID # |
9-1 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
February 8, 2018 |
| Last updated |
February 14, 2018 |
| Start date |
June 1, 2016 |
| Est. completion date |
February 2, 2018 |
Study information
| Verified date |
February 2018 |
| Source |
Antalya Training and Research Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The effect of two different bipolar instruments were compared in terms of operative time,
total operative time, intra-operative blood loss and intra-operative and postoperative
complications. Devices included the LigaSure™ Maryland Jaw 5 mm laparoscopic instrument
(LigaSure; LF 1737, Covidien, Mansfield, MA, USA) and ENSEAL™ G2 Articulating Straight 5mm
Tissue Sealer (ENSEAL; NSLG2S35A, Ethicon Endo-surgery, US, LLC).
Description:
This study is a single-center, single-blinded, randomized control trial that was conducted at
the University of Health Sciences Antalya Training and Research Hospital.
The study was single-blinded in that the patient was not informed of their group assignment;
it is impossible to blind the surgeon using the devices.
Methods and Procedures:
Patients were recruited from outpatient clinics and informed about the study before
enrollment. Women aged over 18 years scheduled for laparoscopic hysterectomy for benign
indications between June 2016 and November 2017 were included in the study after obtaining
written consent.
Women who had given consent were randomized one day before surgery to one of two groups:
Group 1: The Ligasure device used during the hysterectomy. Group 2: The articulating Enseal
device used during the hysterectomy.
Inclusion Criteria:
- Age 18 or older
- Able and willing to provide informed consent
Exclusion Criteria:
- Under 18 years of age
- Suspected malignancy
Surgical technique:
All laparoscopic procedures were performed under general anesthesia. An experienced surgeon,
who has an experience of over 100 cases of TLH with both LigaSure and Enseal, performed all
the procedures. Because both devices have long been used in the operations, they are always
ready for use in our operation rooms. During the study, the first assistant was always a
second or a third year assistant surgeon and the second assistant holding the uterine
manipulator was a first year assistant surgeon. Operative time was recorded in minutes with a
digital watch by a first year resident by dictation of the primary surgeon of the start and
stop times.
After positioning the patient in lithotomy position and placement of a Foley catheter, a Rumi
II (CooperSurgical, Inc, Trumbull, CT, USA) uterine manipulator with Koh cup (Bard Medical,
Covington, GA, USA) of appropriate size was placed. The first assistant stood on the right
side of the patient and held the camera. The second assistant held the uterine manipulator.
The abdominal cavity was entered by direct trocar insertion. The site of insertion varied,
being the umbilicus or Lee-Huang point, according to the size of the uterus. After
pneumoperitoneum was obtained, the patient was positioned in the Trendelenburg position and
three additional trocars, all 5 mm in size, were inserted from both inguinal regions and
suprapubic region. Following exploration of the abdominal cavity, adhesiolysis was performed
where necessary. The round ligaments were sealed and transected, the bladder peritoneum was
opened, the utero-ovarian ligaments were sealed and cut, the bladder peritoneum was dissected
from the vagina, the uterine vessels were skeletonized, sealed and dissected followed by
sacro-uterine ligament dissection and finally the vaginal wall on the rim of the vaginal part
of the uterine manipulator was cut by Harmonic AceTM. The uterus was removed vaginally in all
operations but in case of large uteri, either a Chardonnen's morcellation knife (Karl Storz
GmBH, Tuttlingen, Germany) or a power morcellator was used for uterine section before
retrieval. The vaginal cuff was closed by laparoscopic stitching with number 1 Vicryl suture.
In cases where bilateral or unilateral salpingo-oophorectomy was also indicated, the
procedure was performed after removal of the uterus in order to prevent interference with
operative time which was our primary outcome measure. To seal and transect uterine
attachments, the LigaSure™ Maryland Jaw 5 mm laparoscopic instrument (LigaSure; LF 1737,
Covidien, Mansfield, MA, USA), using the ForceTriadTM Energy Platform (Covidien, Boulder, CO,
USA) was used in one group and ENSEAL™ G2 Articulating Straight 5mm Tissue Sealer (ENSEAL;
NSLG2S35A, Ethicon Endo-surgery, US, LLC) using the Ethicon GEN11TM generator (Ethicon
Endo-surgery, US, LLC) was used in the other group.
Follow-up was performed on postoperative day 7, and then at 1 month.Patients were also seen
at our clinic if they developed symptoms between follow-up visits and complications recorded.
