Wounds and Injuries

All Conditions

Symptoms and General Pathology

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Pain

Genital Neoplasms, Female

Urogenital Neoplasms

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Central Nervous System Depressants

All Drugs and Chemicals

Analgesics

Pharmaceutical Solutions

Anesthetics

Ropivacaine

Anesthetics, Local

Continuous wound infusion device used in this study was ON-Q Painbuster Silver Soaker (I-Flow Corporation, Lake Forest, CA, USA) comprised an elastomeric pump maintaining constant pressure to infuse 2ml/hour of analgesic to the wound through a catheter for 50 hours. In all participants, the surgeon inserted a 20-gauge, 6.5-cm, multi-holed soaker catheter through an introducer needle after closure of the transumbilical fascia. The catheter was located in the deep subcutaneous space, above the fascia near the skin incision. In the experimental group, an elastomeric pump filled with local analgesic solution (total volume 100ml) containing 750mg ropivacaine .

Continuous wound infusion device used in this study was ON-Q Painbuster Silver Soaker (I-Flow Corporation, Lake Forest, CA, USA) comprised an elastomeric pump maintaining constant pressure to infuse 2ml/hour of analgesic to the wound through a catheter for 50 hours. In all participants, the surgeon inserted a 20-gauge, 6.5-cm, multi-holed soaker catheter through an introducer needle after closure of the transumbilical fascia. The catheter was located in the deep subcutaneous space, above the fascia near the skin incision. In the control group, an elastomeric pump filled with filled with 100ml of 0.9% saline .

Continuous wound infusion device used in this study was ON-Q Painbuster Silver Soaker (I-Flow Corporation, Lake Forest, CA, USA) comprised an elastomeric pump maintaining constant pressure to infuse 2ml/hour of analgesic to the wound through a catheter for 50 hours. In all participants, the surgeon inserted a 20-gauge, 6.5-cm, multi-holed soaker catheter through an introducer needle after closure of the transumbilical fascia. The catheter was located in the deep subcutaneous space, above the fascia near the skin incision. In the experimental group, an elastomeric pump filled with local analgesic solution (total volume 100ml) containing 750mg ropivacaine .

Ropivacaine is local analgesics.

0.9% saline group

ON-Q Painbuster Silver Soaker (I-Flow Corporation, Lake Forest, CA, USA)

ON-Q Painbuster Silver Soaker

Taejong Song, MD PhD

Naehyun Lee, MD

Taejong Song, MD, PhD

Studies evaluating the effectiveness of continuous wound infusion (CWI) to manage postoperative pain following laparoscopy are markedly lacking. Especially, there was no study comparing CWI and placebo in treating gynecologic laparoscopy. Therefore, the investigators conducted this randomized, double-blind, placebo-controlled trial to investigate whether CWI of local anesthetics was an effective strategy for enhanced recovery after surgery (ERAS), compared with placebo in patients undergoing benign gynecologic laparoscopy.

Laparoscopic surgery has become an acceptable alternative for open surgery in treating benign gynecologic diseases. One of most important advantages of laparoscopy is a reduced postoperative pain compared with open surgery. Moreover, postoperative pain plays an important part in the enhanced recovery after surgery (ERAS) pathway. Although the length of hospitalization and recovery period after laparoscopy tends to be shorter, postoperative pain can still be an important issue.

Recently, continuous wound infusion (CWI) providing a constant flow of local anesthetic directly a surgical wound postoperatively has been widely used to reduce pain after cesarean section and open surgery. Studies evaluating the effectiveness of CWI to manage postoperative pain following laparoscopy are markedly lacking. Especially, there was no study comparing CWI and placebo in treating gynecologic laparoscopy. Therefore, the investigators conducted this randomized, double-blind, placebo-controlled trial to investigate whether CWI of local anesthetics was an effective strategy for ERAS, compared with placebo in patients undergoing benign gynecologic laparoscopy.

Postoperative Analgesic Efficacy of Continuous Wound Infusion After Laparoscopy

Postoperative Analgesic Efficacy of Continuous Wound Infusion With Local Anesthetics After Laparoscopy (PAIN): a Randomized, Double-blind, Placebo-controlled Trial

The postoperative pain was measured using a visual analog scale (VAS) at 24 hours after surgery by several assessors who were blinded to the interventions. The scale was presented as a 10-cm line with verbal descriptors ranging from "no pain" to "worst imaginable pain".

Rescue analgesia (75 mg diclofenac sodium administered intramuscularly or 25mg pethidine intramuscularly) was provided upon participant request

Kangbuk Samsung Hospital

Professor

Dermatologic Agents

Simethicone

Emollients

women take 6 tablets (2 tablets after each meal) and to fast overnight before the operation

women take 3 rectal Enema (8:00 pm, 12:00 am \& 8:00 am) and to fast over night before the operation.

sodium dihydrogen phosphate dihydrate 19.2 gram \& disodium hydrogen phosphate dodecahydrate 7.2 gram, in addition to purified water

Enema

Altayeb Mostafa, MBBCh

Altayeb Mostafa

Mechanical bowel preparation aims to decrease the volume fecal content in the colon, which thereby decreases the total colony count of bacteria, thus, decreasing peritoneal contamination in case of bowel injury, improving the access to the surgical field and facilitating intraoperative bowel manipulation

Does Simethicone Improve Operative Field in Gynecological Operations

Assiut University

Coagulants

Hemostatics

This group of women undergoing hysterectomy is randomized to the energy device, Vi-sealer.

This group of women undergoing hysterectomy is randomized to the energy device, Ligasure.

This group of women undergoing hysterectomy is randomized to energy devices other than Ligasure.

Vi-Sealer

Ligasure

Using other AHDs such as Thunderbeat, Harmonic scalpel, Caiman®, Enseal, etc. except Ligasure

Other AHD

Hyun Park

Min Jung Kim

This study's primary goal is to compare the efficacy and safety of the novel advanced hemostatic device(AHD), Vi-Sealer, with conventional AHDs in laparoscopic total hysterectomy for patients with benign gynecologic neoplasm.

Vi-Sealer is a reusable advanced bipolar electrode with an interchangeable blade. This study evaluates the efficacy and safety of the Vi-Sealer by comparing it with other advanced hemostatic devices, such as Ligasure, Enseal, Thunderbeat, Harmonic scalpel, etc. The economic evaluation of the device compared with other disposable devices would also be conducted.

Efficacy and Safety Evaluation of Vi-sealer

Efficacy and Safety Evaluation of Advanced Vessel Sealing Device (Vi-sealer)

Measure the time consumed from the initial skin incision to the closure of abdominal trocar sites

Medical costs according to hemostatic instrument use

Ergonomics and subjective hemostatic performances assessed by surgeons using the survey

Collect only for adverse events that have a relationship with medical devices for clinical trials

Laparoscopic Assisted Vaginal Hysterectomy

Abhilasha Agarwal, MS

Minilaparotomy hysterectomy (MLH) relies on the simplicity of traditional open technique of abdominal hysterectomy, imparts cosmesis and faster recovery of laparoscopic hysterectomy yet avoids the long learning curve, cost of expensive setup and instrumentation associated with the minimally invasive approaches namely laparoscopy and robotics. In the present study, we tried to ascertain if the results obtained with MLH can be compared to LAVH in terms of its feasibility, intraoperative variables, and complications. The null hypothesis was that both MLH and LAVH are comparable techniques, so where cost and surgeon's experience are the confining issues, patients can be reassured that MLH gives comparable results.

Around 600,000 hysterectomies are performed every year in the United States, making hysterectomy the second most common surgery for women, first being cesarean section. Most of the hysterectomies are done for non cancerous conditions. And the most common indication for the same is symptomatic fibroid uterus.

In spite of being the most common gynaecological surgery the route of hysterectomy has always been an issue of debate since early 19th century. In the beginning it started as vaginal hysterectomy which soon was taken over by laparotomy route. With the advent of laparoscopy as the recent minimally invasive route the choices have further increased. Laparoscopic route has prompted the need for development of other forms of hysterectomy which are minimally invasive and are associated with less perioperative morbidity with better postoperative outcomes. Abdominal route includes both conventional and minilaparotomy; laparoscopic route includes both Laparoscopic Assisted Vaginal Hysterectomy (LAVH) as well as Total Laparoscopic Hysterectomy (TLH). Each method has its own advantages and disadvantages. The vaginal route is preferable because it is associated with less perioperative morbidity and faster recovery. Although laparoscopic route offers minimally invasive alternative to abdominal hysterectomy when vaginal route is contraindicated (In case of huge fibroid uterus or patients with pelvic pathology), it has its own drawbacks. The laparoscopic instruments are costly, there is a long learning curve involved in the training, and the operating time with this route is prolonged.

The EVALUATE study suggested that majority of surgeons(67%) preferred abdominal approach as the route of surgery, especially when dealing with pelvic pathology. Hence, minilaparotomy hysterectomy as an alternative minimally invasive surgery method was started. It relies on traditional open techniques and inexpensive instrumentation, making it significantly faster than laparoscopy and easy to perform. Hoffman et al found minilaparotomy hysterectomy procedure effective and safe in non-obese women in whom vaginal approach was contraindicated. Fanfani et al did a retrospective analysis on 252 patients who underwent minilaparotomy hysterectomy and found it to be a feasible route of surgery in benign gynaecological conditions with operative time similar or shorter as compared to vaginal, laparotomy and laparoscopy surgery. Few surgeons have modified the incision depending on the their experience which led to development of Pelosi method of Minilaparotomy Hysterectomy in 2003.

The final choice of the route and method depends on multiple factors which include indication of surgery, size of fibroid, equipments available in the surgical set up, surgeons' expertise, patient's financial background.

All patients followed the same standard pre-operative protocol. All surgeries were performed under general anesthesia with endotracheal intubation. Demographic details that included age, parity, body mass index (BMI), baseline investigations, diagnosis, and co-morbidities, were collated a day prior to the day of surgery. On admission, patients were informed in detail about the operation modalities and the associated complications. Patients along with their relatives were counselled about the advantages and disadvantages of both the surgical methods and the final decision was made on a joint consensus between the surgeon and the patient, following which an informed written consent was obtained.

The aim of the study was to compare the feasibility of two minimally invasive surgical procedures in low resource settings (such as India) - Laparoscopic assisted vaginal hysterectomy (LAVH) and Minilaparotomy hysterectomy (transverse suprapubic incision \<7cm).

Comparative Study of LAVH and Minilaparotomy Hysterectomy

Comparative Study of Laparoscopic Assisted Vaginal Hysterectomy and Minilap Hysterectomy for Benign Gynaecological Conditions

All IPD that underlie results in a publication maybe shared after sponsor approval. Present status - undecided.

Weight and height will be combined to report BMI in kg/m\^2

All surgeries were performed by two gynecologists with an almost equal level of surgical competence.

Total amount of blood loss was calculated during both the methods. It was calculated by adding up the mop count (one fully soaked mop \~ 50 ml of blood loss) and the amount of fluid in the suction pump minus the saline used for irrigation.

There are various methods to score pain. In our study, we used visual analogue scale for the scoring. The pain was scored every 6th hourly for the first 24hrs and thereafter 24th hourly till 72 hrs.

The Visual Analogue Scale (VAS) (Figure 14) is a scoring scale on which the patient rates his/her pain on a scale of 0 to 10, 0 representing no pain and 10 representing excruciating or intolerable pain. The scoring is subjective and gives the patient freedom to choose the intensity of the pain as per their perception.

Visceral injury such as bladder/ ureter / bowel injury

Secondary haemorrhage, Urinary Tract Infection, Urinary retention, Wound infection, Thrombo-embolic complications, Febrile morbidity

Manipal University

Junior Resident

Procedures performed using a 5 mm diameter, 35 cm length curved branch radiofrequency tissue sealer connected to a dedicated electric generator

Procedures performed using a 5 mm diameter, 35 cm classic rotating bipolar forceps

Operative laparoscopies carried out according to the most recent national guidelines and following the good clinical practice of our operative unit.

Laparoscopy

The kind of equipment used during laparoscopic surgery may have an effect on how quickly resident surgeons improve their skills.

The effects of these technologies on various general and specialized procedures have been the subject of numerous research, all of which have produced comparable results in terms of efficacy and safety. Although a minimally invasive laparoscopy represents the gold standard method in over 70% of procedures for uterine and adnexal benign diseases, there is a paucity of evidence regarding the potential advantages or disadvantages of such kinds of devices in gynecologic laparoscopy.

Based on this, the purpose of this study was to determine whether using a hemostatic surgical device affects how quickly gynecology residents learn to execute simple laparoscopic procedures and how well they perform surgically.

Effects of Tissue Sealers on Minor Laparoscopic Procedures Between Obstetrics and Gynecology Residents

Numeric Rate Scale (NRS) 0-10 considering 0 for "inadequate vision" and 10 for "optimal vision"

NRS 0-10 (considering 0 for "extremely easy" and 10 for "extremely difficult")

NRS 0-10 (considering 0 for "complicated or incomplete procedure" and 10 for "uncomplicated and satisfying intervention")

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Postoperative Analgesic Efficacy of Continuous Wound Infusion After Laparoscopy	NCT03645304	Benign Gynecolo...	Ropivacaine 0.9% saline gro... ON-Q Painbuster...	18 Years - 80 Years	Kangbuk Samsung Hospital
Does Simethicone Improve Operative Field in Gynecological Operations	NCT03009604	Benign Gynecolo...	Simethicone Enema	20 Years - 60 Years	Assiut University
Does Simethicone Improve Operative Field in Gynecological Operations	NCT03009604	Benign Gynecolo...	Simethicone Enema	20 Years - 60 Years	Assiut University
Efficacy and Safety Evaluation of Vi-sealer	NCT05629611	Benign Gynecolo...	Vi-Sealer Ligasure Other AHD	20 Years - 65 Years	CHA University
Does Simethicone Improve Operative Field in Gynecological Operations	NCT03009604	Benign Gynecolo...	Simethicone Enema	20 Years - 60 Years	Assiut University
Postoperative Analgesic Efficacy of Continuous Wound Infusion After Laparoscopy	NCT03645304	Benign Gynecolo...	Ropivacaine 0.9% saline gro... ON-Q Painbuster...	18 Years - 80 Years	Kangbuk Samsung Hospital
Comparative Study of LAVH and Minilaparotomy Hysterectomy	NCT03548831	Hysterectomy Minimal Invasiv... Benign Gynecolo...		-	Manipal University
Effects of Tissue Sealers on Minor Laparoscopic Procedures Between Obstetrics and Gynecology Residents	NCT05710601	Benign Gynecolo...	Laparoscopy	18 Years -	University of Campania "Luigi Vanvitelli"
Postoperative Analgesic Efficacy of Continuous Wound Infusion After Laparoscopy	NCT03645304	Benign Gynecolo...	Ropivacaine 0.9% saline gro... ON-Q Painbuster...	18 Years - 80 Years	Kangbuk Samsung Hospital
Efficacy and Safety Evaluation of Vi-sealer	NCT05629611	Benign Gynecolo...	Vi-Sealer Ligasure Other AHD	20 Years - 65 Years	CHA University
Effects of Tissue Sealers on Minor Laparoscopic Procedures Between Obstetrics and Gynecology Residents	NCT05710601	Benign Gynecolo...	Laparoscopy	18 Years -	University of Campania "Luigi Vanvitelli"

Spots Global Cancer Trial Database for benign gynecologic neoplasm