Decrease Blood Loss During Abdominal Hysterectomy Clinical Trial
Official title:
Liga Sure Versus Conventional Suture Ligature for Decrease Blood Loss During Abdominal Hysterectomy: Randomized Controlled Trial
Liga Sure represents a novel principle for hemostatic sealing of vessel-containing tissue
based on feedback-programmed dosage of bipolar diathermy.(5) According to marketing of the
device, Liga Sure has the potential to replace the use of conventional suture ligature within
a broad range of surgical procedures, also including removal of the uterus. While the use of
Liga Sure has been critically assessed for a range of procedures such as hemorrhoidectomy,
splenectomy, bile duct, urological and gastric operations,(6-12) a similar scientific
evaluation of its suitability for abdominal removal of the uterus is lacking in the
literature. The most promising aspect of Liga Sure in hysterectomy is the potential shorter
operation time and decrease blood loss. Because removal of the uterus traditionally is the
most frequently performed major gynecological operation,(13) the introduction of a
time-sparing new technique could have significant impact on resource consumption.
The aim of the study:
we aimed at evaluating the use of Liga Sure compared with conventional suture ligature during
abdominal hysterectomy, in a prospective randomized controlled trial with special emphasis on
the safety, the duration of the procedure and the amount of blood loss.
Hysterectomy represents the second most performed surgery in gynecology after the Cesarean
Section. Worldwide most of the hysterectomies are performed abdominally. (1) One in 9 women
will undergo a hysterectomy in their lifetime. (1) Surgical blood loss of more than 1000 mL
or blood loss that requires a blood transfusion usually defines intraoperative hemorrhage.
Intraoperative hemorrhage has been reported in 1% to 2% of hysterectomy studies. (2) As with
any surgical treatment, complications affect the outcomes of hysterectomy. Hemorrhage, which
is the most frequent and critical complication, often occurs during surgery. Data from The
Danish Hysterectomy and Hysteroscopy Database (DHHD) has revealed a relatively high
complication rate of 16-18% from 1998 to 2006, of which perioperative bleeding complications
represent the most common cause.(3 )From 2004 to 2006, 6-8% of all women undergoing benign
hysterectomy in Denmark experienced a bleeding complication .(4 ) Therefore, adequate
hemostatic techniques are essential during abdominal hysterectomy. Currently, surgical
hemostasis can be secured by a variety of methods, including mechanical sutures (or
clamping), electric coagulation, ultrasonically activated scalpel or drugs. (4)
Liga Sure represents a novel principle for hemostatic sealing of vessel-containing tissue
based on feedback-programmed dosage of bipolar diathermy.(5) According to marketing of the
device, Liga Sure has the potential to replace the use of conventional suture ligature within
a broad range of surgical procedures, also including removal of the uterus. While the use of
Liga Sure has been critically assessed for a range of procedures such as hemorrhoidectomy,
splenectomy, bile duct, urological and gastric operations,(6-12) a similar scientific
evaluation of its suitability for abdominal removal of the uterus is lacking in the
literature. The most promising aspect of Liga Sure in hysterectomy is the potential shorter
operation time and decrease blood loss. Because removal of the uterus traditionally is the
most frequently performed major gynecological operation,(13) the introduction of a
time-sparing new technique could have significant impact on resource consumption.
The aim of the study:
we aimed at evaluating the use of Liga Sure compared with conventional suture ligature during
abdominal hysterectomy, in a prospective randomized controlled trial with special emphasis on
the safety, the duration of the procedure and the amount of blood loss.
Materials and Methods After obtaining ethics committee approval and patient consent, we will
randomize patients about to undergo elective abdominal hysterectomy, between the use of Liga
Sure and conventional suture ligature during the operation. Patients who were admitted for
non-acute planned abdominal total or subtotal hysterectomy were eligible. Two experienced
lecturer gynecologists performed the operations. 60 patients for each of the tow operators
were block-randomized. The treatment options, 30 of each in each randomization block, were
first concealed in envelopes. Thereafter, the sequence was generated using computer-generated
random number lists. The 60 projected patients will include and will be randomized between
December 2017 and December 2019. The following pre- and intra-operative parameters will be
registered: the indication for the operation, the type of incision, procedures in addition to
the hysterectomy, the duration of the operation, the blood loss and the use of
intra-operative blood transfusions. When Liga Sure was used, the eventual number of its
replacements by suture ligature due to unsuccessful vessel sealing was registered. During the
first 30 post-operative days, the following parameters were registered: all types of
re-operations, the use of blood transfusion, the occurrence of fever above 38°C, all types of
infections, deep vein thrombosis and the length of the post-operative hospital stay.
Measurement of Blood Loss Blood loss well be estimated by a combination of direct measurement
and gravimetric method (14). The direct measurement well performed by collecting most of the
lost blood into a suction bottle using a suction apparatus. Care was taken to collect most of
(if not all) the amniotic fluid in a separate suction bottle. The gravimetric method well
used to estimate the amount of blood loss in the surgical towels. The dry surgical towels (40
by 40 cm) were weighed before surgery. Intraoperatively, the towels were used to dry up all
the blood in the surgical field then these towels were collected into a sterile metallic bowl
which was weighed empty before surgery. When 5 soaked towels are collected in the bowl, the
bowl with the collected soaked towels are handled to the circulating nurse to weigh it by a
highly accurate digital balance and then calculate the amount of blood loss in the towels by
the following formula: amount of blood loss in the soaked towels (in ml) = weight of the
metallic bowl with the collected soaked towels in it (in gm)— [weight of the empty bowel (in
gm) + weight of the towels before surgery (in gm)]. The collected blood in the suction bottle
well added to the total calculated amount of blood loss in the towels.
The primary outcomes are the total blood loss during and after hysterectomy. the secondary
outcome is another surgical maneuver to decrease blood loss (need of suturing in the Liga sur
arm), operative time ,any complication Statistical Analysis; Continuous variables were
presented as mean ± standard deviation, while categorical variables were presented as
frequencies and percentages. The IBM (SPSS) Statistics, version 20.0, for Windows was used
for statistical analysis. P values ≤0.05 were considered statistically significant.
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