Neoplasms

All Conditions

Musculoskeletal Diseases

Pelvic Neoplasms

Bone Neoplasms

In the template-guided group (n = 10), a navigation template was designed and applied to assist acetabular reconstruction using a modular hemipelvic prosthesis.

In the traditional operation group (n = 14), acetabulum was manually reconstructed using a modular hemipelvic prosthesis by the surgeon's experience.

In the validation group (n = 12), patients undergoing periacetabular puncture or curettage without acetabulum reconstruction.

In the template-guided group (n = 10), a navigation template was designed and applied to assist acetabular reconstruction. In the traditional operation group (n = 14), the patients underwent the same surgery but without the navigation template. To compare the displacement of the hip rotation center before and after surgery between the two groups, an innovative method based on pelvic CT was developed and a validation group of cases was used to assess the effectiveness of this measurement approach. In the validation group (n = 12), patients undergoing periacetabular puncture or curettage without hip joint reconstruction were included. The displacements for the validation group were calculated and compared with 0 cm, the theoretical value. Subsequently, the displacements between the template-guided group and the traditional operation group were compared.

Acetabular reconstruction after tumor resection.

Nong Lin

Donghua Huang

Background:

Acetabular reconstruction in situ after extensive pelvic resection is technically challenging because the significant loss of bone stock and bony landmarks. The aim of the present study was to investigate the feasibility of an individualized navigation template for acetabular reconstruction following pelvic malignancy resection.

Methods:

This retrospective cohort study included patients who underwent type II or II+III pelvic tumor resection and reconstruction using a modular hemipelvic prosthesis. In the template-guided group (n = 10), a navigation template was designed and applied to assist acetabular reconstruction. In the traditional operation group (n = 14), the patients underwent the same surgery but without the navigation template. To compare the displacement of the hip rotation center before and after surgery between the two groups, an innovative method based on pelvic CT was developed and a validation group of cases was used to assess the effectiveness of this measurement approach. In the validation group (n = 12), patients undergoing periacetabular puncture or curettage without hip joint reconstruction were included. The displacements for the validation group were calculated and compared with 0 cm, the theoretical value. Subsequently, the displacements between the template-guided group and the traditional operation group were compared.

This study is a "Retrospective Cohort Study" through retrospectively collecting patients undergoing acetabulum reconstruction after pelvic tumor resection. The patients were interfered with or without the acetabular navigation template during the hip reconstruction process.

A Positioning Navigation Template for Assisting the Placement of Modular Hemipelvic Endoprostheses for Patients Undergoing Pelvic Bone Tumor Resection.

A Novel Positioning Navigation Template for Accurately and Precisely Assisting the Placement of Modular Hemipelvic Endoprostheses for Patients Undergoing Pelvic Bone Tumor Resection: A Retrospective Cohort Study

Compare the change of acetabular rotation center (the displacement displayed in centimeters) before and after surgery between the template-guided group and the traditional operation group based on preoperative and postoperative CT images.

Second Affiliated Hospital, School of Medicine, Zhejiang University

Harriet Smith, MD

SGO Society of Gynecologic Oncologists Data Outcomes Project.

SGO Society of Gynecologic Oncologists Data Outcomes Project

University of New Mexico

Children with a pelvic or retroperitoneal tumor requiring an MRI or CT scan for a possible surgical intervention

Thomas BLANC, MD

Gael PLASTOW

Sabine SARNACKI, MD

This study's purpose is the comparison of the automatically segmented 3D model to the reference manual segmentation, based on the Dice precision index. It is implemented by making parents' patients, surgeons and surgical helpers answer specific questions comparing 3D images to usual 2D images of the patient's tumor.

The investigator will inform the child and his parents during the pre-surgical consultation, and will collect their non-opposition to be included in the study at the latest on the day of the MRI examination or CT scan. Patients requiring emergency imaging will not be included.

Pelvic tumors will benefit from MRI imaging and renal tumors from MRI and/or CT scan.

A CT scan will be carried out for retroperitoneal tumors other than renal tumors (mainly neuroblastomas).

All of the above examinations are carried out as part of the usual treatment, in the month preceding the surgery.

Pre-operatively After the imaging has been carried out, the 2D images will be presented to the patient and his family before surgery as it is done routinely. The 3D image will be showed afterwards. The family will have the opportunity to ask questions which the surgeon will answer as usually done.

The specific questionnaire will be completed by the patient and his family at the end of the consultation and given to the research team.

Once the patient is included and the examinations have been carried out, the operating surgeons and their assistants (help No. 1 and 2) will look at the 2D images, followed by the 3D images secondly a few days before surgery. They will complete the specific questionnaire and give it to the research team.

Once the patient is included and the imaging examinations have been carried out, surgeons external to the service will be contacted by the research team to organize a remote review session. The 2D images will be presented to them first, followed by the 3D images on the visualization software, via a remote communication system with screen sharing. They will complete the specific questionnaire independently and a copy of the questionnaires will then be sent to the research team by email and the originals sent by post.

Intraoperatively:

The 3D model of the patient will be displayed in the operating room, and/or integrated into the robot's display console (for robot-assisted surgeries) during the surgical procedure. At the end of the surgery, the operating surgeon and his assistants will complete (independently) a questionnaire on the consistency of the 2D and 3D images with the anatomy identified during the procedure and on the help or not provided by the 3D model.

Contribution of 3D Modeling in Surgical Management of Pediatric Retroperitoneal and Pelvic Tumors

Non-interventional Study on the Contribution of 3D Modelling in Surgical Management of Pediatric Retroperitoneal and Pelvic Tumors Compared to 2D Imaging

Comparison of the automatically segmented 3D model to the reference manual segmentation

Distance comparison between the reference segmentation and the one obtained by the algorithm

Recognition of anatomical structures comparison from 2D imaging and 3D imaging by surgeons preoperatively

Contribution of 3D modeling comparison to 2D imaging in pre-operative planning

Added value evaluation of 3D modelling compared to 2D imaging for surgeons pre-operatively

Surgeons' support evaluation for integrating 3D modelling into routine pre-operative planning

Evaluation of the contribution of 2D imaging for families in understanding the information (pathology and surgery) delivered by the surgeon to parents pre-operatively

Evaluation of the contribution of 3D modelling for families in understanding the information (pathology and surgery) delivered by the surgeon to parents pre-operatively

Added value evaluation of 3D modelling compared to 2D imaging for families pre-operatively

Contribution of 3D modelling evaluation compared to 2D imaging for surgeons during surgery

Consistency evaluation of the 3D imaging with anatomy observed intraoperatively

Surgeons' support evaluation for integrating 3D modeling into their current practice

Imagine Institute

Assistance Publique - Hôpitaux de Paris

60 patients with pelvic tumors will undergo arteriography and receive transcatheter arterial embolization of pelvic tumors 0-24 hours prior to surgery.

60 patients with pelvic tumors will undergo arteriography and without transcatheter arterial embolization of pelvic tumors prior to surgery.

Arteriography and transcatheter arterial embolization of pelvic tumors 0-24 hours prior to surgery.

Arteriography and precision preoperative embolization

Arteriography of pelvic tumors 0-24 hours prior to surgery.

Arteriography

XIN ZHI

PING YIN

The main purpose of this study is to assess the efficacy of precision preoperative embolization in decreasing operative blood loss, reducing surgical complications in pelvic tumor surgery. Furthermore the study aims at describing the vascularity in a series of pelvic tumors, and to correlate this with perioperative blood loss.

The main purpose of this study is to assess the efficacy of precision preoperative embolization in decreasing operative blood loss, reducing surgical complications in pelvic tumor surgery，which including poor wound healing，nerve injury，and pelvic organs dysfunction. Furthermore the study aims at describing the vascularity in a series of pelvic tumors,which contains four grade：poor，moderate，rich and abundant and to correlate this with perioperative blood loss.

Precision Preoperative Embolization of Pelvic Tumors to Improve Surgical Outcomes

Perioperative blood loss measured intraoperatively

Including symptoms of nerve compression, pelvic organ ischemia injury

including poor wound healing，nerve injury，pelvic organ dysfunction

it contains four grades：poor、moderate、rich、abundant

blood loss measured through the drainage within 2 postoperative days

Peking University People's Hospital

Doctor

Thoracic Neoplasms

Patients with pelvic or thoracic tumors with an indication for radiotherapy treated with oART (online Adaptied Radiotherapy).

Patients with pelvic or thoracic tumors with an indication for radiotherapy treated with conventional IGRT (Image Guided Radiotherapy).

Laura Anna Fischer

Rami El Shafie

This prospective registry-based trial will include patients with pelvic or thoracic tumors with an indication for radiotherapy treated with oART or IGRT. For the primary endpoint and the secondary clinical endpoints, the trial will compare oART versus IGRT, for technical endpoints the trial will compare the real oART scenario with two virtual (hypothetical) control scenarios.

Primary endpoint:

* 10% reduction in the rate of acute radiotherapy related toxicity (≥ CTCAE II°, v5.0) using oART

Secondary endpoints:

* Clinical endpoints: Tumor control, late toxicities compared to conventional irradiated patients, quality of life and patient-reported outcomes
* Technical endpoints: Target volume, target coverage, dose to organs at risk, anatomical variability score

Background: Conventional Radiotherapy (Image Guided Radiotherapy, IGRT) requires a CT-based treatment planning process a priori. During this process, a treatment plan is calculated, which then is applied to the patient with a linear accelerator on a daily basis, possibly using image guidance to account for variability in patient position. However, daily changes of the anatomy of targets and organs at risk (OARs) can only be addressed by applying additional safety margins, resulting in larger irradiated volumes and possibly higher toxicity.

A promising and innovative technique for margin and in consequence toxicity reduction is online Adaptive Radiotherapy (oART) using daily imaging to create a "plan of the day" aligned to the actual anatomy by means of artificial intelligence (AI) and with the patient on the treatment couch. This approach is especially promising in the pelvic region due to the high anatomic variability, e.g. caused by peristalsis or volume changes of bladder and rectum. Furthermore, the application of oART in the field of thoracic tumors is being evaluated. oART is an already established form of treatment which is used regulary everyday in clinical practice and is not a study-related intervention. A direct comparison of both techniques IGRT vs. oART is missing.

Methods: This prospective and retrospective registry-based trial will include patients with pelvic or thoracic tumors with an indication for radiotherapy treated with oART or IGRT. For the primary endpoint and the secondary clinical endpoints, the trial will compare oART versus IGRT, for technical endpoints the trial will compare the real oART scenario with two virtual (hypothetical) control scenarios as follows:

* oART - Applied treatment: AI-based daily treatment plan creation, adapted to daily anatomy
* Virt 1 - Hypothetical dose distribution of initial treatment plan, based on the initial planning CT
* Virt 2 - Hypothetical dose distribution of initial treatment plan, applied to the anatomy of the day as depicted by cone-beam CT at the treatment machine

Pelvic Cancer Registry for Online Adapted Radiotherapy

Pelvic and Thoracic Cancer Treated With Online Adapted Radiotherapy: A Prospective Registry-based Phase-II Trial

10% reduction in the rate of acute radiotherapy related toxicity (≥ CTCAE II°, v5.0) using oART

University Medical Center Goettingen

Clinical Study Management on behalf of the Principal Investigator

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Prostatic Neoplasms

Urinary Bladder Neoplasms

Carcinoma, Renal Cell

Ureteral Neoplasms

Kidney Calculi

Calculi

Nephrolithiasis

Cysts

Ureteral Calculi

Ureterolithiasis

Adrenal Gland Neoplasms

Penile Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Male Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urologic Diseases

Kidney Diseases

Pathological Conditions, Anatomical

Penile Diseases

Urolithiasis

Urinary Calculi

Ureteral Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Penile Cancer

Vasoconstrictor Agents

Respiratory System Agents

All Drugs and Chemicals

Epinephrine

Racepinephrine

Epinephryl borate

Patients with urological diseases (renal cell carcinoma, nonfunctioning kidney and adrenal tumor, renal pelvis carcinoma, ureteral tumor, bladder cancer, prostate cancer, pelvic tumor) will be treated by telesurgery.

telesurgery of urological diseases by domestic surgical robot

telesurgery by domestic surgical robot

Haitao Niu, MD

Haitao Niu, PhD

A single-arm clinical trial was designed in this study. The surgeon will perform urological telesurgery for patients using Chinese domestically produced "MicroHand S" surgical robot system. The "MicroHand S" surgical robot system consists of two physically separated subsystems named the "surgeon console" and the "patient side cart". The surgeon console includes a stereo image viewer, two master manipulators, a control panel and several foot pedals. The patient side cart includes a passive arm that can slide in the up-down direction and be adjusted forward and backward, a swivel head that can rotate around the vertical axis, and three slave arms. In addition, surgical instruments and sterile bags are the essential accessories for the "patient side cart". The principle of the telesurgery is as follows: the surgeon console takes the surgeon's input and translates manipulation into a control signal. After network transmission, the signals will be received by the patient side cart and will be used to control the slave robot to manipulate the instruments to perform the operation within the patient's cavity. The 3D images captured by the endoscopic camera will be simultaneously sent back to the screen of the surgeon console as visual feedback. Data between the surgeon console and the patient side cart will be transmitted through a 5G network or other advanced network networking scheme. The surgeon remotely manipulates the slave arms and performs surgeries for patients in remote areas. The safety and efficacy of the robot system in remote clinical treatment will be verified by the primary and the secondary evaluation criteria. One hundred patients with urological diseases will be enrolled in the clinical trial.

Primary evaluation criterion:

The success rate of the surgery. Surgery success is defined as that all surgeries are performed remotely and safely without transfering to other types of surgery, such as open surgery or normal robot-assisted surgery.

Secondary evaluation criteria:

Operative time, blood loss, postoperative pain, preoperative adjusting time, hospitalization time, average network latency, task load, peer recognition, anxiety index.

Patient enrollment:

This experiment aims to investigate the safety and effectiveness of the domestic robot system in clinical urological surgery under the current network networking scheme. It is planned that 100 patients with urinary system diseases will participate in the clinical trial.

Objective: This clinical trial aims to evaluate the efficacy and safety of telesurgery for patients with urological tumors using Chinese independently developed "MicroHand S" Surgical Robot System under the current advanced network networking scheme.

Content: A single-arm clinical trial was designed in this study. The product is domestically produced "MicroHand S" surgical robot system (Shandong Weigao Surgical Robot Co., Ltd, China). The patients will be fully informed and the written informed consent will be signed before the clinical study, According to the inclusion criteria and exclusion criteria, the researchers will conduct a detailed screening to determine whether the patients are suitable for the clinical study. Telesurgery will be conducted for patients who meet the inclusion criteria using the "MicroHand S" surgical robot system. Data between the "surgeon console" and the "patient side cart" will be transmitted through the current advanced network networking scheme. Fifty telesurgeries has been performed for patients with renal tumor, adrenal tumor, or nonfunctional kidney disease in 2021. All the surgeries were completed successfully, which made an positive social influence. In order to explore other indications, 100 subjects will be enrolled in the clinical trial. All diseases will be included if it is applicable to be treated by telesurgery, such as, adrenal tumor, renal tumor, renal cyst, duplex kidney, renal calculi, ureteral calculi, ureteropelvic junction obstruction (UPJO), nonfunctional kidney, renal pelvis tumor, ureteral tumor, bladder cancer, prostate cancer, pelvic tumor, penile cancer, etc. The safety and efficacy of remote clinical treatment using the domestic robot system will be verified according to the primary evaluation criterion, secondary evaluation criteria, and safety evaluation index.

Network connection plan: Two network connection plans were designed in advance to transmit data between the two sites (the master and the slave) in telesurgery. Plan A: Both signals (the control signals and the video signals) were transmitted in a VPN encryption mode under 5G wireless network or other advanced network networking scheme. Plan B: Both signals were transmitted through the dedicated line. When 5G network or other advanced network networking scheme was unstable and the surgery was affected, Plan A could be switched to Plan B to ensure the success of telesurgery. The two sites were also connected through a video conference system for real time communication and coordination.

Primary evaluation criterion: The primary evaluation criterion is the success rate of the surgery.

Secondary evaluation criteria: Secondary evaluation criteria include operative time, intraoperative blood loss, assembly time, postoperative pain, hospital stay, time to first flatus, average network latency, task load index, patient acceptance of telesurgery, peer surgeon acceptance of telesurgery, patient anxiety index, surgeon anxiety index.

Safety evaluation index: (1) Organ and vascular injury events related to the robot, including the following injury events: a. Whether there is adjacent organ injury caused by the robot functional failure during the operation, including liver, spleen and intestinal injury; b. Whether there is hemorrhoea caused by vascular injury caused by the robot functional failure during the operation. (2) Adverse events during the study. (3) Instrument malfunction. a. The communication between the "surgeon console" and the "patient side cart" is strongly disturbed, the slave arms fail to move and malfunction cannot be eliminated after reset and restart. b. by surgical instruments cannot be loosened after the tissue is clamped. c. An alarm sounds when install the instruments. d. Instruments lose efficacy or they are damaged. (4) Vital signs (body temperature, blood pressure, and heart rate). (5) Laboratory examination: blood routine, liver and kidney function, electrolyte.

Researcher selection: In order to strictly ensure the homogeneity and uniformity of researchers, operators are required to have certain qualifications. All surgeons must have at least 5 years of experience in laparoscopic general surgery and at least 1-year experience in robotic surgery. The surgeon will be trained in delay simulation training before the trial. Meanwhile, product training is also required before the trial, and each surgeon must complete at least 20 surgeries with the tested robot. All the trainings above are to help surgeons cross the learning curve.

Background: With the combination of robotic and network communication technology, telesurgery has become a reality. On the one hand, telesurgery can conserve and optimize medical resources, providing high-quality medical services to unbalanced areas, such as rural areas, stricken areas and battlefields. On the other hand, telesurgery can reduce the time spent by patients waiting for treatment and thus prevent diseases from worsening. In recent years, the rapid advancements of the fifth and sixth generation network communication technologies and surgical robotic devices have again boosted the development of telesurgery since the Lindbergh operation and the research of Anvari et al. Especially in a country as vast as China, where the difference of the level of medical care between developed cities and rural areas is huge and the need for telesurgery is enormous. The demand for telemedicine has also risen significantly, particularly since the outbreak of COVID-19. However, as the most challenging components of telemedicine, telesurgery has still developed slowly, and most studies of it are limited to single-center experiences and as such have some inherent limitations. Based on this background, we have successfully conducted preliminary studies in which we verified the safety and feasibility of multiple network plans for telesurgery such as 5G network slicing technology and heterogeneous multilink network converged transmission technology.

In 2021, our research group carried out a multicenter prospective study evaluating efficacy and safety of telesurgery for upper urological tumors using the "Micro Hand S" system robot and a 5G network in Shandong Province, China.

With the prevalence of telesurgery, indications should not limited in upper urological diseases. More indications should be explored. On such basis, this clinical trial was designed and performed.

The Efficacy and Safety of Chinese Domestic Surgical Robot System in Urological Telesurgery

The Efficacy and Safety of Chinese Domestic Surgical Robot System in Urological Telesurgery, an Exploratory Study

The success of the telesurgery is the robot-assisted telesurgery without transfering to other types of surgery, such as open surgery or normal robot-assisted surgery. The number of the success divided by the total number is the success rate.

The operative time is from the time the robot is assembled till the incision is sutured.

Intraoperative blood loss is the total amount of blood loss from the beginning of the operation (after the robot is assembled) to the incision is sutured. The blood loss is estimated by weight. Estimated blood loss (g) = the weight of the gauze wiping up all the blood - the weight of the dry gauze. And 1g = 1ml.

Postoperative pain is assessed by a visual analog scale (VAS) with a range from 0 point (no pain) to 10 points (maximum pain) at 24±2 hours postoperatively.

The assembly time is from the time the robot starts to the time the trocar is connected to the robot arm.

The hospital stay is the total number of days from the admission to the discharge of patients.

Average network latency is monitored by specific software in real time during the telesurgery.

Task load will be evaluated through NASA-TLX questionnaire filled by the surgeons.

Patient acceptance of telesurgery will be assessed through TPSQ questionnaire filled by the patients 1 day before operation.

Peer surgeon acceptance of telesurgery will be systematic reviewed through TAKA questionnaire filled by peer surgeons.

Patient anxiety index will be assessed through TP-SAS questionnaire filled by patients.

Surgeon anxiety index will be assessed through TP-SAS questionnaire filled by operating surgeons and assistant surgeons.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Positioning Navigation Template for Assisting the Placement of Modular Hemipelvic Endoprostheses for Patients Undergoing Pelvic Bone Tumor Resection.	NCT04980729	Pelvic Tumor	Acetabular reco...	-	Second Affiliated Hospital, School of Medicine, Zhejiang University
A Positioning Navigation Template for Assisting the Placement of Modular Hemipelvic Endoprostheses for Patients Undergoing Pelvic Bone Tumor Resection.	NCT04980729	Pelvic Tumor	Acetabular reco...	-	Second Affiliated Hospital, School of Medicine, Zhejiang University
SGO Society of Gynecologic Oncologists Data Outcomes Project	NCT00320996	Pelvic Tumor		-	University of New Mexico
Contribution of 3D Modeling in Surgical Management of Pediatric Retroperitoneal and Pelvic Tumors	NCT06418243	Pelvic Tumor Retroperitoneal...		3 Months - 17 Years	Assistance Publique - Hôpitaux de Paris
A Positioning Navigation Template for Assisting the Placement of Modular Hemipelvic Endoprostheses for Patients Undergoing Pelvic Bone Tumor Resection.	NCT04980729	Pelvic Tumor	Acetabular reco...	-	Second Affiliated Hospital, School of Medicine, Zhejiang University
Contribution of 3D Modeling in Surgical Management of Pediatric Retroperitoneal and Pelvic Tumors	NCT06418243	Pelvic Tumor Retroperitoneal...		3 Months - 17 Years	Assistance Publique - Hôpitaux de Paris
Precision Preoperative Embolization of Pelvic Tumors to Improve Surgical Outcomes	NCT05633134	Embolization Pelvic Tumor	Arteriography a... Arteriography	18 Years - 70 Years	Peking University People's Hospital
Pelvic Cancer Registry for Online Adapted Radiotherapy	NCT06185062	Pelvic Tumor Thoracic Tumor		18 Years -	University Medical Center Goettingen
The Efficacy and Safety of Chinese Domestic Surgical Robot System in Urological Telesurgery	NCT05739812	Renal Cell Carc... Adrenal Tumor Nonfunctioning ... Renal Pelvis Ca... Ureteral Tumor Bladder Cancer Prostate Cancer Pelvic Tumor Renal Cyst Duplex Kidney Renal Calculi Ureteral Calcul... Ureteropelvic J... Penile Cancer	telesurgery by ...	18 Years - 80 Years	The Affiliated Hospital of Qingdao University

Spots Global Cancer Trial Database for pelvic tumor

Every month we try and update this database with for pelvic tumor cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.