Liga Sure Versus Conventional Suture Ligature for Decrease Blood Loss During Abdominal Hysterectomy

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.

Study Overview

• Status: Completed
• Conditions: Decrease Blood Loss During Abdominal Hysterectomy
• Intervention / Treatment: Procedure: conventional suture

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Aswan, Egypt, 81528
    • AswanUH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• patient prepared for an elective benign hysterectomy

Exclusion Criteria:

1. Patients with a cardiac, hepatic, renal or thromboembolic disease.
2. patients with pelvic endometriosis and adnexal mass.
3. patients with endometrial or cervical cancer
4. radical hysterectomy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: conventional suture ligature; use of conventional sutures for hysterectomy	Procedure: conventional suture; we use Liga-sure device for hysterectomy
ACTIVE_COMPARATOR: Liga Sure; use of conventional sutures plus use of Liga-sure for hysterectomy	Procedure: conventional suture; we use Liga-sure device for hysterectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
decrease blood loss during hysterectomy	Blood loss well be estimated by a combination of direct measurement and gravimetric method	intra-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
need for blood transfusion,	number RBC unit trasfused	intraoperative
post operative HB	measure HB pos operative	24 hour post operative
operative time	time of operation	intra operative

Collaborators and Investigators

• Sponsor: Aswan University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2018
• Primary Completion (ACTUAL): September 30, 2019
• Study Completion (ACTUAL): December 30, 2019

Study Registration Dates

• First Submitted: April 7, 2018
• First Submitted That Met QC Criteria: April 12, 2018
• First Posted (ACTUAL): April 23, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 7, 2020
• Last Update Submitted That Met QC Criteria: January 6, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: aswu/202/18

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No