Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Hemorrhage

Prolapse

Leiomyoma

Myofibroma

Uterine Prolapse

Uterine Hemorrhage

Pathological Conditions, Anatomical

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Pelvic Organ Prolapse

Patients submitted to vaginal cuff closure after total laparoscopic hysterectomy using a 3D laparoscopic camera

Patients submitted to vaginal cuff closure after total laparoscopic hysterectomy using a 4k laparoscopic camera

Francesco Fanfani, Professor

Stefano Restaino, MD

This prospective randomized trial aims to assess if the operative time of vaginal cuff suture performed by trainees could be reduced using 3D laparoscopy instead of 4K laparoscopy.

All patients with benign uterine pathology at preoperative examinations (pelvic ultrasound and / or magnetic resonance and / or CT) and with indication for total laparoscopic hysterectomy with consequently need for laparoscopic suture of the vaginal cuff, will be enrolled in the study.

- I TIME/OUT OF PROTOCOL TIME (performed by expert surgeons) While under general anesthesia, the patient is positioned in the dorsal lithotomic position with both legs supported in stirrups with a Trendelenburg tilt and arms along the body. A four disposable or reusable, sterile trocar transperitoneal approach is used. A 10 mm port is inserted at the umbilicus for the telescope. Once pneumoperitoneum (12 mmHg) is achieved, intra-abdominal visualization will be obtained with a 0° 4K high-definition telescope (VISERA UHD 4K 10 mm, Olympus Winter \& IBE GMBH, Hamburg - Germany) or with 0° 3D laparoscopy high-definition (Olympus Winter \& IBE GMBH, Hamburg - Germany).

Two additional 5 mm ports are placed under direct visualization, in the right lower abdomen medial to the right obliterated umbilical artery and in the left lower abdomen lateral to the inferior epigastric vessels. One more 5-mm trocar is inserted in the right mid abdomen at the level of the umbilicus. The instruments used include bipolar grasper, monopolar scissors, monopolar hook, various graspers and a suction irrigation system. Clermont Ferrand uterine manipulator (Model K.Storz Endoskope,Tuttlingen, Germany) is optionally used to move the uterus.

Total hysterectomy is then performed according to standard technique.

- II TIME/PROTOCOL TIME (performed by surgeon in training) The vaginal vault is closed with a 0 Vycril suture laparoscopically (continuous suture). In order to avoid excess operating time, 15 min was allocated for completion of cuff closure by surgeons-in-training, after which time the attending surgeon took over this task.

Operative time, estimated blood loss, incidence of intra or post-operative complications, postoperative pain, days of hospitalization and costs will be recordered

4K Versus 3D Laparoscopic Colporraphy by Surgeons in Training: a Prospective Randomized Trial

- Evaluate the incidence of postoperative complications (dehiscence of the vaginal cuff, fever, urinary tract infections, surgical wound infections)

To compare the time taken to close the vaginal cuff, which was defined as time, starting from the initial grasp of the suture to cutting the suture, with 3D Laparoscopy vs 4K laparoscopy

Evaluate the incidence of intraoperative complications in the two laparoscopic system (intraoperative blood loss, need for intraoperative transfusions, bladder lesions, ureteral lesions, vascular lesions, intestinal lesions)

Catholic University of the Sacred Heart

professor

Digestive System Diseases

Rare Diseases

Prostatic Neoplasms

Kidney Diseases

Endometriosis

Cholecystitis

Acalculous Cholecystitis

Intestinal Obstruction

Renal Insufficiency, Chronic

Renal Insufficiency

Male Urogenital Diseases

Urologic Diseases

Chronic Disease

Disease Attributes

Gallbladder Diseases

Biliary Tract Diseases

Gastrointestinal Diseases

Intestinal Diseases

Chronic Graft Versus Host Disease

All Drugs and Chemicals

Central Nervous System Depressants

Other Dietary Supplements

Rocuronium

Benzocaine

Neuromuscular Nondepolarizing Agents

Neuromuscular Blocking Agents

Tannic Acid

This group will undergo deep neuromuscular blockade, defined as post tetanic count (PTC) of 1 to 2, in the beginning portion of the surgery followed by a period of moderate blockade.

This group will undergo moderate neuromuscular blockade, defined as 1-2 twitches, in the beginning portion of the surgery followed by a period of deep blockade.

Rocuronium infusion will be paused and the Train of Four (TOF) monitor will be set to every 1-2 min. Once the patient has achieved a "moderate" NMB state (one to two twitches), the infusion of the muscle relaxant will be resumed at a low dose to maintain the patient at this level of blockade.

Deep to Moderate NMB

Rocuronium infusion will be increased in increments of 0.1-0.2 mg/kg/hr. and the TOF monitor will be set to every 1-2 min. Once the patient has no twitches and a PTC of 0-1 ("deep" NMB) the infusion will be adjusted to maintain the patient at this level of NMB.

Moderate to Deep NMB

Ruchir Gupta, MD

This is a two period cross-over study randomizing patients undergoing laparoscopic surgery into 2 different groups: group 1 in which patients receive "deep neuromuscular blockade" in the beginning portion of their laparoscopic surgery followed by a period of "moderate blockade" and, group 2 in which patients receive "moderate neuromuscular blockade" in the beginning portion of their laparoscopic surgery followed by a period of "deep blockade". The deep neuromuscular block is defined as post tetanic count of 1 to 2 and the moderate neuromuscular block is defined as 1-2 twitches. In all patients, sugammadex is used to reverse the block at the end of surgery in order to obtain optimal extubating conditions.

Neuromuscular blockade (NMB) is frequently utilized in laparoscopic procedures to improve surgical conditions by relaxing the abdominal muscles and thus facilitating insufflation with carbon dioxide to optimize surgical view. Increased airway pressures can lead to an increase in alveolar and perivascular edema, a decline in dynamic lung compliance and hypoxemia.

Several studies have investigated surgical view under deep vs. moderate neuromuscular blockade. Literature supports deep neuromuscular blockade providing better operating conditions/view by a surgeon and low airway pressures but, potentially, longer duration to extubation and worse respiratory mechanics at the end of anesthesia versus moderate neuromuscular blockade which shows worse operating conditions/view by a surgeon and worse airway pressures but possibly shorter duration to extubation and better respiratory mechanics at the end of anesthesia.

Thus, there is clearly equipoise with regard to the comparative effectiveness of deep vs medium NMB. Therefore, this study is designed to ascertain if a deep neuromuscular block will decrease the airway pressures in patients undergoing laparoscopic procedures compared to those under a moderate block. A reduction in airway pressures may lead to a decrease in the complications associated with elevated airway pressures including hypoxemia, total static lung compliance, alveolar edema, and long term morbidity. Additionally, the study aims to determine if time from administration of sugammadex to reversal is different between patients that have a moderate NMB as compared to a deep NMB.

Deep Versus Moderate Neuromuscular Blockade During Laparoscopic Surgery

Effect of Deep Versus Moderate Neuromuscular Blockade on Peak Airway Pressures During Elective Laparoscopic Surgery

Fully analyzed results may be shared with Merck Investigator Studies Program personnel after the study has completed

To determine if a deep NMB can lead to lower peak airway pressures in patients undergoing laparoscopic procedures when compared to a moderate NMB

To compare surgical operating condition by Abdominal Insufflation Pressure in patients undergoing laparoscopic procedures using deep NMB versus moderate NMB

To compare surgical operating condition by Surgical Rating Scale (SRS) in patients undergoing laparoscopic procedures using deep NMB versus moderate NMB

Surgical Rating Score scores are on a 1-5 scale with 1 = extremely poor conditions, 2 = poor conditions, 3 = adequate conditions, 4 = good conditions, 5= excellent conditions. Higher scores mean a better outcome.

Merck Sharp & Dohme LLC

Stony Brook University

Clinical Assistant Professor

This group will underwent neuromuscular blockade, defined as post tetanic count (PTC) of 1 to 2, in the beginning portion or during the second portion of the surgery

Deep NMB

This group underwent moderate neuromuscular blockade, defined as 1-2 twitches, in the beginning portion of the surgery or during the second portion of the surgery

Moderate NMB

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Procedure

Dr. Ruchir Gupta

Mean

Maximum

This group underwent deep neuromuscular blockade, defined as post tetanic count (PTC) of 1 to 2, in the beginning portion of the surgery or during the second portion of the surgery

This group underwent moderate neuromuscular blockade, defined as 1-2 twitches, in the beginning portion of the surgery or during the second period of the surgery

Peak Airway Pressures

This group underwent deep neuromuscular blockade, defined as post tetanic count (PTC) of 1 to 2, in the beginning portion or during the second portion of the surgery

Abdominal Insufflation Pressure

ModerateNMB

Surgical Rating Scale

This group will undergo deep neuromuscular blockade, defined as post tetanic count (PTC) of 1 to 2, in the beginning portion of the surgery followed by a period of moderate blockade.

Rocuronium

Deep to Moderate Neuromuscular Block (NMB)

This group will undergo moderate neuromuscular blockade, defined as 1-2 twitches, in the beginning portion of the surgery followed by a period of deep blockade.

Rocuronium

Period 1

Period 2

patients submitted to total hysterectomy using a 3D laparoscopic camera

patients submitted to total hysterectomy using a 2D laparoscopic camera (standard laparoscopic camera)

total laparoscopic hysterectomy using a 3D laparoscopy high-definition system

0° 3D laparoscopy high-definition camera(Olympus Winter & IBE GMBH, Hamburg - Germany)

Due to the inconclusive results on the benefits of 3D laparoscopic system present in literature, this prospective randomised pilot study aims to assess if the operative time of total laparoscopic hysterectomy (TLH) for benign indication performed by trainees could be reduced using 3D laparoscopy instead of standard laparoscopy.

All patients with benign uterine pathology at preoperative examinations (pelvic ultrasound and/or magnetic resonance and/or CT scan) and with indication for total laparoscopic hysterectomy, will be enrolled in the study.

While under general anesthesia, the patient is positioned in the dorsal lithotomic position with both legs supported in stirrups with a Trendelenburg tilt and arms along the body. A four disposable or reusable, sterile trocar transperitoneal approach is used. A 10 mm port is inserted at the umbilicus for the telescope. Once pneumoperitoneum (12 mmHg) is achieved, intra-abdominal visualization will be obtained with a 0° high-definition telescope (HD EndoEye 10 mm, Olympus Winter \& IBE GMBH, Hamburg - Germany) or with 0° 3D laparoscopy high-definition (Olympus Winter \& IBE GMBH, Hamburg - Germany). The instruments used include bipolar grasper, monopolar scissors, monopolar hook, various graspers and a suction irrigation system. Clermont Ferrand uterine manipulator (Model K.Storz Endoskope,Tuttlingen, Germany) is optionally used to move the uterus.

Total hysterectomy is then performed according to standard technique used by the recruiting center (development of the pararectal space and identification of uterine artery, coagulation of ovarian pedicles, development of the vesico-uterine septum, colpotomy).The vaginal vault is then closed with a 0 Vycril suture laparoscopically (continuous suture).

Detailed operative time, intra and post operative early complications will be recorded (Extended Clavien-Dindo classification of surgical complications will be used for post operative complications)

Can 3D Laparoscopy Improve Surgical Performances in Surgeons in Training?

2D Versus 3D Total Laparoscopic Hysterectomy by Surgeons in Training: a Prospective Randomized Trial

To compare operative time for Total Laparoscopic Hysterectomy with 3D laparoscopy vs. conventional laparoscopy

• Evaluate the incidence of intraoperative complications in the two laparoscopic system (intraoperative blood loss, need for intraoperative transfusions, bladder lesions, ureteral lesions, vascular lesions, intestinal lesions)

Evaluate the incidence of postoperative complications (need for postoperative transfusions, dehiscence of the vaginal cuff, fever, urinary tract infections, surgical wound infections)

Professor

Gland and Hormone Related Diseases

Nervous System Diseases

Uterine Cervical Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Unconsciousness

Uterine Neoplasms

Endometrial Neoplasms

Fallopian Tube Neoplasms

Adnexal Diseases

Genital Neoplasms, Female

Urogenital Neoplasms

Fallopian Tube Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Barbed suture SYMMCORA® used for the vaginal cuff closure in female patients undergoing total laparoscopic hysterectomy. The product under investigation and the comparator suture material will be used in routine clinical practice and according to the Instructions for Use (IfU).

Barbed suture V-Loc® used for the vaginal cuff closure in female patients undergoing total laparoscopic hysterectomy. The product under investigation and the comparator suture material will be used in routine clinical practice and according to the Instructions for Use (IfU).

Closure of the vaginal cuff in patients undergoing laparoscopic total hysterectomy. The product under investigation and the comparator suture material will be used in routine clinical practice and according to the Instructions for Use (IfU).

Closure of the Vaginal Cuff after Total Hysterectomy

Petra Baumann

Amadeus Hornemann, Prof. Dr.

Lourdes Hinojosa Sánchez, Dra.

Arantxa Monteils Llabenia, Dra.

Núria Grané Garcia, Dra

Carmen Bergos Sorolla, Dra.

The aim of this study is to show the superiority of the new unidirectional barbed suture (SYMMCORA® mid-term, unidirectional) to conventional suture material in terms of time to perform the vaginal cuff closure during gynecologic surgeries without an increase in the complication rate.

Secondly, the superiority of SYMMCORA®, mid-term unidirectional compared to the V-Loc®, unidirectional will be assessed regarding the mean time to close the vaginal cuff. The study will be performed in routine clinical setting, the only difference will be the randomization into two different suture groups. Both suture materials which will be applied to approximate the vaginal cuff are approved and carrying the CE-marks. Additionally, both sutures will be applied in their intended use. Neither additional invasive measures nor additional burden in regard to the patient will be performed.

Performance of SYMMCORA® vs. V-Loc® Suture Material in Patients Undergoing Laparoscopic Total Hysterectomy

Prospective, International, Randomized, Multicentric, Controlled Study on the Performance of SYMMCORA® Mid-term Unidirectional Barbed Suture Versus V-loc® Suture Material in Patients Undergoing Laparoscopic Total Hysterectomy

Measured in Minutes. Time to perform the vaginal cuff closure after laparoscopic total hysterectomy using a stop watch. Time starts when the needle passes the first time the tissue and ends after completion of the wound closure (cut of the needle from the thread).

Documented early complications include Hemoglobin drop and Fever more than 38°C within 48 hours

Documented complications include Vaginal cuff infection, Vaginal cuff dehiscence (Defined as a visually confirmed partial or complete opening of the vaginal stump with or without visceral organ herniation), Vaginal cuff granulation formation, Pelvic Abscess Formation, Hematoma, Vaginal spotting (defined as bloody vaginal discharge that did not require extraordinary procedures or medication and disappeared spontaneously. (Days of postoperative bleeding, Number of pads / tampons used), Vaginal bleeding (Defined as postoperative vaginal stump bleeding that required additional stump suture to stop bleeding. (Days of postoperative bleeding, number of pads / tampons used), Urinary tract infection, Bladder injury, Ureter injury, Bowel obstruction, Ileus, Cystitis and Pelvic Adhesions.

Documented device deficiencies include Suture rupture, Knots in the thread, Connection between needle and thread not intact and Disconnection of the anchor from the thread

The patient's self assessment of her satisfaction with the surgery. This parameter will be noted using the Visual Analogue Scale (VAS), represented by a line 10 cm of length, which states "0" at one end representing "low" and "100" at the opposite end representing "high". The value is measured in \[mm\] with a ruler and documented in whole numbers.

The Female Sexual Function Index (FSFI) is a 19-item, self-report measure of female sexual function that provides scores on overall levels of sexual function as well as the primary components of sexual function in women, including sexual desire, arousal, orgasm, pain, and satisfaction. The 19 items of the FSFI use a 5-point Likert scale ranging from 1-5 with higher scores indicating greater levels of sexual functioning on the respective item. (0 points in some cases for items that are not applicable). To score the measure, the sum of each domain score is first multiplied by a domain factor ratio (0.6 for desire; 0.3 for arousal and lubrication; 0.4 for orgasm, satisfaction and pain) in order to place all domain totals on a more comparable scale, and then subsequently summed to derive a total FSFI score. The domain scores range from 1.2 - 6, the overall score ranges from 7.2 - 36.

From the first cut to the end of the surgery

Calculation using the length of hospitalization (days until discharge), suturing time, suture costs and needed transfusions)

calculated by subtracting the surgery date from the date of discharge

The patient's self assessment of her abdominal pain. This parameter will be noted using the Visual Analogue Scale (VAS), represented by a line 10 cm of length, which states "0" at one end representing "no pain" and "100" at the opposite end representing "heavy pain". The value is measured in \[mm\] with a ruler and documented in whole numbers

The patient's self assessment of her pelvic pain. This parameter will be noted using the Visual Analogue Scale (VAS), represented by a line 10 cm of length, which states "0" at one end representing "no pain" and "100" at the opposite end representing "heavy pain". The value is measured in \[mm\] with a ruler and documented in whole numbers

The patient's self assessment of her lumbar pain. This parameter will be noted using the Visual Analogue Scale (VAS), represented by a line 10 cm of length, which states "0" at one end representing "no pain" and "100" at the opposite end representing "heavy pain". The value is measured in \[mm\] with a ruler and documented in whole numbers

The patient's self assessment of her general health status. Health status is based on assessment of the patient to the question, "Would you say your health in general is...:" The options are excellent / very good / good / fair / poor

Dyspareunia is defined by genital pain that can be experienced before, during, or after intercourse. The patient answers with yes or no.

Assessment of the handling of the unidirectional barbed suture (SYMMCORA®) intra-operatively including eleven different dimensions (pliability, Pass-through, traumaticity, anchoring capacity, safety of closure, locking system size, locking system deployment, locking system unbarbed area, locking system safety of closure, atraumaticity, wound closure approximation) and an overall impression with 5 evaluations levels (excellent, very good, good, satisfied, poor).

Assessment of the handling of the barbed suture (SYMMCORA®) compared to conventional suture regarding degree of difficulties and the ease of handling. (Likert Scale: strongly agree, agree, neither agree nor disagree, disagree, strongly disagree).

Assessment of the barbed suture (SYMMCORA®) compared to barbed suture (V-Loc®) regarding smoothness, suppleness, traumaticity of the thread, the handling, the opening of the package and the overall opinion (Likert Scale: worse, equal, better).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
4K Versus 3D Laparoscopic Colporraphy by Surgeons in Training: a Prospective Randomized Trial	NCT04637022	Uterine Fibroid Uterine Bleedin... Uterine Prolaps...		-	Catholic University of the Sacred Heart
Deep Versus Moderate Neuromuscular Blockade During Laparoscopic Surgery	NCT02812186	Cholecystitis Endometriosis Bowel Obstructi... Fibroids Prostate Cancer Chronic Kidney ... Uterine Prolaps...	Deep to Moderat... Moderate to Dee... Rocuronium	18 Years -	Stony Brook University
Deep Versus Moderate Neuromuscular Blockade During Laparoscopic Surgery	NCT02812186	Cholecystitis Endometriosis Bowel Obstructi... Fibroids Prostate Cancer Chronic Kidney ... Uterine Prolaps...	Deep to Moderat... Moderate to Dee... Rocuronium	18 Years -	Stony Brook University
4K Versus 3D Laparoscopic Colporraphy by Surgeons in Training: a Prospective Randomized Trial	NCT04637022	Uterine Fibroid Uterine Bleedin... Uterine Prolaps...		-	Catholic University of the Sacred Heart
Can 3D Laparoscopy Improve Surgical Performances in Surgeons in Training?	NCT04209036	Uterine Fibroid Uterine Bleedin... Uterine Prolaps...	0° 3D laparosco...	-	Catholic University of the Sacred Heart
4K Versus 3D Laparoscopic Colporraphy by Surgeons in Training: a Prospective Randomized Trial	NCT04637022	Uterine Fibroid Uterine Bleedin... Uterine Prolaps...		-	Catholic University of the Sacred Heart
Can 3D Laparoscopy Improve Surgical Performances in Surgeons in Training?	NCT04209036	Uterine Fibroid Uterine Bleedin... Uterine Prolaps...	0° 3D laparosco...	-	Catholic University of the Sacred Heart
Performance of SYMMCORA® vs. V-Loc® Suture Material in Patients Undergoing Laparoscopic Total Hysterectomy	NCT06024109	Abnormal Uterin... Endometriosis Uterine Prolaps... Uterine Cancer Ovarian Cancer Fallopian Tube ... Cervical Cancer Endometrial Can...	Closure of the ...	18 Years -	Aesculap AG

Spots Global Cancer Trial Database for uterine prolapse