Liga Sure Versus Conventional Suture Ligature for Decrease Blood Loss During Abdominal Hysterectomy
Condition: Decrease Blood Loss During Abdominal Hysterectomy
MeSH terms: Hemorrhage
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): conventional suture
Intervention type(s): Procedure
Intervention description(s): we use Liga-sure device for hysterectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: single-blinded randomized trials
Masking: Single (Participant)
Primary purpose: Treatment