Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Hemorrhage

Fibroma

Neoplasms, Fibrous Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

3-D laparoscopy

2-D laparoscopy

Elise Hoffmann, MD

Background:

No randomised trials have been conducted, and only a single retrospective study exists comparing 3D and 2D laparoscopic hysterectomy. In that study, operative time for hysterectomy was significantly lower for 3D compared to 2D conventional laparoscopy. Complication rates were similar for the two groups. Thus, although one out of nine women is hysterectomized and although laparoscopy is one of the recommended routes of surgery, evidence whether to choose 2D laparoscopy, 3D laparoscopy is sparse.

Objective:

To compare pain and recurrence to usual activity level. Secondary to compare complications during the operation, postoperative complications, time to return to work, length of hospital stay and operative time.

Design:

Investigator-initiated, blinded, randomised controlled trial.

Intervention description:

Operative procedures follow the same principles and the same standard whether the surgeon's vision is 2D or 3D.

Trial size Roskilde/Herlev Hospital, Denmark:

200 patients in each arm of the study.

2-D and 3-D Laparoscopic Hysterectomy

3-dimensional Versus Conventional Laparoscopy in Patients Undergoing Total Hysterectomy for Benign Disease - A Randomised Clinical Trial

Zealand University Hospital

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Infections

Nervous System Diseases

Leiomyoma

Myofibroma

Pain

Pelvic Pain

Endometriosis

Adenomyosis

Pelvic Inflammatory Disease

Pelvic Infection

Menorrhagia

Metrorrhagia

Communicable Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Neurologic Manifestations

Uterine Diseases

Uterine Hemorrhage

Menstruation Disturbances

Adnexal Diseases

Total laparoscopic hysterectomy, laparoscopic assisted vaginal hysterectomy

Laparoscopic hysterectomy

Abdominal hysterectomy

Kimberly Kho, MD, MPH

The purpose of the proposed pilot study is to investigate the effectiveness, cost, safety, and long-term impact on quality of life of laparoscopic hysterectomy (LH) in relation to abdominal hysterectomy (AH) for the treatment of benign gynecologic disease in women through a randomized surgical trial.

The overall hypothesis is that neither mode of hysterectomy will be consistently superior to the other with respect to each of the three domains of complications, cost, and patient-centered outcomes. The overall goal of the study is to determine which clinically relevant factors may impact the choice of LH compared to AH. The results of the study may be useful for clinicians, patients, hospital administrators and health policy makers.

Surgical Success After Laparoscopic vs Abdominal Hysterectomy

Randomized Trial of Laparoscopic Versus Abdominal Hysterectomy for Benign Indications and Impact on Surgical Success

1) Patient-centered outcomes composite

1. Quality of life - measured using the Short Form 12 (SF-12v2),
2. Sexual functioning - measured using the Sexual Activity Questionnaire (SAQ)
3. Body image - measured using the Body Image Scale (BIS)
4. Return to normal activity -measured using the Activities Assessment Scale (AAS)
5. Pain - measured using a 10 point likert scale
6. Productivity - measured using a questionnaire about missed work

Hospital charges and indirect costs of missed work/caregiving due to hysterectomy will be calculated

Intraoperative and postoperative complications including conversions, unintentional lacerations/injury to organs, hemorrhage, infection, wound complications, VTE, death, pain, neuropathy

University of Texas Southwestern Medical Center

Associate Professor, Department of Obstetrics and Gynecology

Carcinoma

Recurrence

Endometrial Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Total hysterectomy with bilateral salpingo-oophorectomy performed with the use of a uterine manipulator during surgery.

Total hysterectomy with bilateral salpingo-oophorectomy performed without the use of a uterine manipulator during surgery.

The uterine manipulator will be inserted into the uterus to assist in the procedure of total hysterectomy.

Uterine manipulator use

Stefano Uccella, MD, PhD

Simone Garzon, MD

Pier Carlo Zorzato, MD

Minimally invasive surgery is the recommended approach in endometrial cancer (EC) patients based on the results of two randomized controlled trials, given its advantages without compromised oncologic outcomes. The uterine manipulator is commonly used in benign and malignant pathologies to perform a laparoscopic or robotic hysterectomy. However, although regularly used, the uterine manipulator adoption in EC is a controversial technical aspect due to the raised concerns regarding the possible risk of disruption of the tumor mass, the spread of malignant cells, and seeding of the disease, particularly at the level of the vaginal cuff or spread of tumor cells, with increased risk of recurrence and death due to EC. On that basis, given that hysterectomy without a uterine manipulator is feasible, only a randomized controlled trial comparing oncologic outcomes in EC patients after use versus not use of the uterine manipulator will be able to provide high-quality evidence to answer this critical question and allow or exclude the use of a uterine manipulator during minimally invasive hysterectomy for EC.

Multicenter, parallel arms, open-label, randomized controlled trial.

Uterine Manipulator Versus no Uterine Manipulator in Endometrial Cancer Trial

Randomized Controlled Trial on the Oncologic Outcomes of Use Versus Not Use of the Uterine Manipulator in the Surgical Treatment of Apparent Uterine-confined Endometrial Carcinoma

Any recurrence or death related to endometrial cancer (EC) or treatment

Any death related to endometrial cancer (EC) or treatment

Any recurrence per site of first recurrence

Time between first incision and skin closure

Total blood aspirate during the surgical procedure

Perioperative (intraoperative and postoperative) complications graded based on the Clavien-Dindo classification

Presence of lymphovascular space invasion at definitive pathology

Presence of positive peritoneal cytology at definitive pathology

The Functional Assessment of Cancer Therapy - General (FACT-G) - A 27-item questionnaire designed to measure four domains of Health-Related Quality of Life in cancer patients: Physical, social, emotional, and functional well-being. Score range 0-108. The higher the score, the better the Quality of Life.

Universita di Verona

Prof. Stefano Uccella

Gland and Hormone Related Diseases

Rare Diseases

Adenocarcinoma

Carcinoma, Endometrioid

Neoplasms, Glandular and Epithelial

Ovarian Neoplasms

Ovarian Diseases

Gonadal Disorders

Endocrine System Diseases

Ovarian Cancer

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

This arm includes patients with endometrioid adenocarcinoma of the endometrium of low- and intermediate-risk who will undergo a laparoscopic total hysterectomy and bilateral salpingo-oophorectomy with sentinel lymph node biopsy (SLNB) performed with near-infrared-guided surgery using indocyanine green (ICG).

Laparoscopic total hysterectomy, bilateral salpingo-oophorectomy (BSO), and sentinel lymph node (SLN) biopsy are executed by 1 of 5 experienced gynecologic oncologists. SLN mapping utilizes indocyanine green (ICG) at a standard concentration of 2.5 mg/mL - 1 mL is injected into the cervix at the 3 and 9 o'clock positions (total dose - 5 mg) to a depth of 5-10 mm, initiated right after general anesthesia induction. Diagnostic laparoscopy employs the Image 1S equipment (KARL STORZ©, Tuttlingen, Germany). Upon examination, fluorescence in the near-infrared spectrum is observed. Successful mapping is indicated by identifying a lymphatic vessel with at least one LN. Detected SLNs are then extracted, and the total hysterectomy with BSO is completed. SLN frozen section remains at the surgeon's discretion. If metastasis surfaces in the SLN either during the frozen section or routine assessment, the option for systematic LN dissection in a subsequent procedure exists although not mandatory.

Laparoscopic total hysterectomy with bilateral salpingo-oophorectomy and sentinel lymph node biopsy

While total hysterectomy without lymph node staging is standard for low- and intermediate-risk endometrial cancer, certain histopathologic factors can necessitate additional interventions. Our study assesses the influence of sentinel lymph node (SLN) biopsy on postoperative decision-making.

A single-center prospective open-label single-arm clinical trial

[SENTRY] Tailoring Postoperative Management Through Sentinel Lymph Node Biopsy in Low- and Intermediate-Risk Endometrial Cancer

Tailoring Postoperative Management Through Sentinel Lymph Node Biopsy in Low- and Intermediate-Risk Endometrial Cancer: a Prospective Open-label Single-arm Clinical Trial

The rate of change in postoperative treatment based on the SLNB results and postoperative histology (percentage). A change in postoperative treatment strategy is defined as any difference between treatment plans set by the tumor board before and after receiving the SLN biopsy information.

The rate of change in disease stage based on SLNB results and postoperative histology (percentage).

The rate of bilateral SLN detection (percentage).

The actual list of intraoperative complications associated with SLN mapping and biopsy. They include but are not limited to an intraoperative bleeding, small and large bowel injury, ureter and bladder injury, nerve injury, and allergic reaction to indocyanine green (ICG).

Percentage of patients experiencing intraoperative complications associated with SLN mapping and biopsy listed above.

Major postoperative morbidity following the procedure (percentage).

Postoperative mortality following the procedure (percentage).

The rate of lower extremities lymphedema (percentage).

The percentage of patients experiencing pelvic recurrence after surgical treatment.

Time from surgical treatment to detected pelvic recurrence in months.

Moscow City Oncology Hospital No. 62

Pain, Postoperative

Antiemetics

Dermatologic Agents

Gastrointestinal Agents

Anti-Inflammatory Agents

Antineoplastic Agents

Analgesics

Antirheumatic Agents

Ondansetron

Dexamethasone

Rocuronium

Ropivacaine

Morphine

Propofol

Dexamethasone acetate

Remifentanil

Ketorolac

Induction: remifentanil in total intravenous anesthesia (TIVA), Propofol 2 mg/kg/h and Rocuronium 0.6 mg/kg. Transversus abdominis plane (TAP) block: 20 minutes before surgery. Ropivacaine 0.37% 20ml + dexamethasone 2mg per side. Maintenance: TIVA with Propofol, the infusion rate will be adjusted according to the bispectral index system (BIS) values (30 \<BIS \<50). Patients will receive additional remifentanil by infusion at 0.02 mcg/kg/min per time if blood pressure and heart rate values exceed 20% pre-operative baseline values. Additional rocuronium 0.1 mg/kg based on clinical needs and train of four (TOF) monitoring. Analgesic starter bolus: 30 minutes before the end of the surgery, paracetamol 1 gr ev and ketorolac 30 mg ev. Postoperative pain: paracetamol 1 gr ev every 8 hours for 36 hours; ketorolac 30 mg ev if NRS \>4 / morphine 2 mg ev if NRS \>4 30 min after ketorolac administration. In case of nausea and vomiting ondansetron 4 mg ev.

Erector spinae plane (ESP) block: 20 minutes before surgery. T8 level bilaterally, ropivacaine 0.37% 20ml + dexamethasone 2mg per side.

Induction: Remifentanil in TIVA, Propofol 2 mg/kg/h and Rocuronium 0.6 mg/kg. Maintenance: TIVA with Propofol, the infusion rate will be adjusted according to the BIS values (30 \<BIS \<50). Patients will receive additional remifentanil by infusion at 0.02 mcg/kg/min per time if blood pressure and heart rate values exceed 20% pre-operative baseline values. Additional rocuronium 0.1 mg/kg based on clinical needs and TOF monitoring.

Analgesic starter bolus: 30 minutes before the end of the surgery, paracetamol 1 gr ev and ketorolac 30 mg ev.

Postoperative pain: paracetamol 1 gr ev every 8 hours for 36 hours; ketorolac 30 mg ev if NRS \>4 / morphine 2 mg ev if NRS \>4 30 min after ketorolac administration. In case of nausea and vomiting ondansetron 4 mg ev.

Post induction TAP block for intra and postoperative analgesia.

General anesthesia + TAP block

Pre induction ESP block for intra and postoperative analgesia.

General anesthesia + ESP block

Chiara Rosato, MD

The anesthetic techniques for videolaparoscopic surgery include general anesthesia, and locoregional anesthesia in association with general anesthesia in order to reduce or abolish post-operative pain with a simultaneous reduction in the use of opioids and days of hospital stay.

From the studies published so far on videolaparoscopic surgery in general, it is clear that the transversus abdominal plane (TAP) block could have a role in reducing the stretch wall pain secondary to pneumoperitoneum and incisional, although its role in this regard is not yet clear, nor significant statistically results have been produced. The use of erector spinae plane (ESP) block for the management of visceral pain is finding more and more space in the literature, with promising results.

For videolaparoscopic gynecological surgery, the techniques of locoregional anesthesia studied in association with general anesthesia, up to now, include wall blocks, TAP block and ESP block, while neuraxial anesthesia has no indications in this regard.

Although videolaparoscopic hysterectomy is considered less painful than the open-abdomen technique, it requires careful management of post-operative pain. The pain of this surgery is the result of the sum of incisional pain, at the insertion points of the laparoscopic trocars, pain due to pneumoperitoneum usually referred to the shoulder, and visceral pain purely dependent on surgical maneuvers. There is currently no strong evidence to support the use of locoregional anesthesia techniques in videolaparoscopic gynecological surgery. Few studies have been produced about this topic, and they are mostly case series or randomized controlled trials that take into consideration only one technique among those possible. To date, no study compares the various techniques to evaluate the possible superiority of one over the other.

In our hospital anesthesists carry out, in normal clinical practice, all the aforementioned local anesthesia techniques.

The purpose of our work is to evaluate, with a randomized non-sponsored study, the efficacy of the ESP block and the TAP block for intra and post-operative pain control in videolaparoscopic hysterectomy, and to compare the two techniques.

Based on the evidence available in the literature, the two techniques are already part of the current clinical practice of the Anesthesia Unit of our hospital and the choice of one technique over the other is based on anesthetist clinical evaluation to date. The anesthetists involved in the study are adequately trained on both anesthetic procedures.

ESP vs TAP in Total Laparoscopic Hysterectomy

Comparison of Efficacy of Ultrasound-guided Erector Spinae Place Block Versus Transversus Abdominis Plane Block for Intra and Postoperative Pain Control in Total Laparoscopic Hysterectomy: a Randomized Controlled Trial

Evaluate the difference between the two groups regarding post-operative pain using Numeric Rating Scale (NRS) 0= better outcome; 10=worse outcome Score will be measured on the numeric rating scale (NRS), an NRS ≤ 4 will be considered as effective antalgic coverage.

Mcg of Remifentanil consumed during surgery.

Mg of ketorolac or any others anti-inflammatory drugs administered after surgery.

Mg of opioids administered after surgery.

Quantity of antiemetic drugs required to control nausea and vomiting episodes

The number of days of hospitalization after surgery will be assessed

Patients is requested to fill out a pre-printed sheet on their judgment of the anesthesiological procedure, in which they can express a value from 0 to 5, where 0 indicates "entirely dissatisfied" and 5 indi- cates "very satisfied"expressed by the patient according to the following scale: satisfied, very satisfied, not at all satisfied

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
2-D and 3-D Laparoscopic Hysterectomy	NCT02610985	Fibroma, Bleedi...	3-D laparoscopy 2-D laparoscopy	18 Years -	Zealand University Hospital
Surgical Success After Laparoscopic vs Abdominal Hysterectomy	NCT01793584	Metrorrhagia Menorrhagia Leiomyoma Adenomyosis Pelvic Pain Endometriosis Pelvic Inflamma...	Laparoscopic hy... Abdominal hyste...	18 Years - 80 Years	University of Texas Southwestern Medical Center
Uterine Manipulator Versus no Uterine Manipulator in Endometrial Cancer Trial	NCT05687084	Endometrial Neo...	Uterine manipul...	18 Years - 100 Years	Universita di Verona
[SENTRY] Tailoring Postoperative Management Through Sentinel Lymph Node Biopsy in Low- and Intermediate-Risk Endometrial Cancer	NCT04972682	Endometrial Can... Endometrial Neo... Endometrial Ade... Endometrial Can... Endometrial Can... Endometrial End... Sentinel Lymph ... Hysterectomy Laparoscopic Hy...	Laparoscopic to...	18 Years -	Moscow City Oncology Hospital No. 62
ESP vs TAP in Total Laparoscopic Hysterectomy	NCT04839445	Anesthesia Gynecologic Can...	General anesthe... General anesthe...	18 Years - 85 Years	AUSL Romagna Rimini

Spots Global Cancer Trial Database for laparoscopic hysterectomy