Neoplasms

All Conditions

Behaviors and Mental Disorders

Rare Diseases

Osteosarcoma

Sarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Quality of Life

Soft Tissue Sarcoma

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Morphine

Patients who underwent surgical resection of a deep intramuscular soft tissue sarcoma of the thigh

A group of healthy age-matched individuals will be identified out of an available gait lab database to compare the gait pattern with tha of the patient group

Patients who underwent surgical resection of a bone or soft tissue sarcoma of the lower extremity

3D-motion analysis and strength assessment

Functional outcome

Quality of Life Questionnaire C-30 (QLQ-C30), Impact on Participation and Autonomy Questionnaire (IPAQ) and Musculoskeletal Tumor Society Score (MSTS)

Health related quality of life (HRQoL) assessment

Hazem Wafa

Moke Lieven

Primary bone and soft tissue sarcomas are an exceptionally rare form of cancer, collectively accounting for only 1% of all malignancies diagnosed. Sarcomas often occur in the patients' extremities and treatment typically involves limb salvage surgery with bone and/or muscle resection. These surgeries often leave the patients with disfigurements, psychological trauma, and functional disabilities. Perhaps, the most difficult and life-altering decision that patients (and their parents) with primary bone sarcomas about the knee joint have to make, involves choosing the type of surgical procedure that will provide them with the outcome that meets their functional as well as aesthetic expectations.

In literature, the quality of life for patients with osteosarcoma around the knee joint after three different surgical procedures, that is, amputation, endoprosthetic reconstruction and rotationplasty was evaluated. There was found that patients treated with rotationplasty showed significantly higher functional scores compared to the two other groups of patients. Also, researchers investigated the long-term quality of life after bone sarcoma surgery around the knee joint and found that, despite the functional disability, survivors were busy with work, study, relationships, and sometimes they have founded a family.

Most published reports in the literature on assessment of gait in the lower-extremity sarcoma survivors were focused on bone sarcoma patients after wide resection and endoprosthetic reconstruction. To the knowledge of the investigator, there has been no published studies on gait analysis after resection of soft tissue sarcomas (STS) of the lower extremity. The rare and heterogeneous aspects of STS and the paucity of knowledge of movement strategies in these patients hinder the development of effective rehabilitation protocols for recovering movement after resection of STS in the lower limb.

Primary bone and soft tissue sarcomas are an exceptionally rare form of cancer, collectively accounting for only 1% of all malignancies diagnosed. There have been dramatic improvements in the survival rate of sarcoma patients in the past 40 years owing to increasing effectiveness of chemotherapy. This, along with developments in imaging techniques, have led to earlier diagnosis and more accurate preoperative staging. It is estimated that there are nearly 50,000 survivors of bone and soft tissue sarcomas in the United States. 70% of those are younger than the age of 50 years. Whilst traditional treatment for bone tumors used to be amputation, advances in surgical techniques have made limb-salvage procedures a valid alternative method of treatment in 80-85% of patients with primary bone sarcomas.

Sarcomas often occur in the patients' extremities and treatment typically involves limb salvage surgery with bone and/or muscle resection. These surgeries often leave the patients with disfigurements, psychological trauma, and functional disabilities. Perhaps, the most difficult and life-altering decision that patients (and their parents) with primary bone sarcomas about the knee joint have to make, involves choosing the type of surgical procedure that will provide them with the outcome that meets their functional as well as aesthetic expectations. In literature, the quality of life for patients with osteosarcoma around the knee joint after three different surgical procedures, that is, amputation, endoprosthetic reconstruction and rotationplasty was evaluated. There was found that patients treated with rotationplasty showed significantly higher functional scores compared to the two other groups of patients. Also, researchers investigated the long-term quality of life after bone sarcoma surgery around the knee joint and found that, despite the functional disability, survivors were busy with work, study, relationships, and sometimes they have founded a family.

There are few reports available in the literature on the quality of life in sarcoma survivors. It was found that elderly patients, retired patients, and those who live alone need more intensive psychological care. Female patients were found to cope poorly with their disease compared to male gender. It was also found that the physical status greatly influences the overall outcome and quality of life in this group of patients. This stresses the importance of enrolment in tailored rehabilitation programs.

Most published reports in the literature on assessment of gait in the lower-extremity sarcoma survivors were focused on bone sarcoma patients after wide resection and endoprosthetic reconstruction. In literature, the gait pattern after endoprosthetic replacement around the knee joint was studied and found that, despite decreased walking velocity, stride length, and stance phase of the operated limb, these patients still have a symmetrical gait. Also in another report, an electromyographic assessment of gait after bone sarcoma surgery about the knee showed prolonged activation of rectus femoris and hamstring muscles in the affected limb compared to a control group. Other researchers found that limb-salvage patients often adopt a "stiff-legged" gait pattern. These findings are of utmost importance for the development of efficient rehabilitation programs for these patients.

To the knowledge of the investigator, there has been no published studies on gait analysis after resection of soft tissue sarcomas (STS) of the lower extremity. The rare and heterogeneous aspects of STS and the paucity of knowledge of movement strategies in these patients hinder the development of effective rehabilitation protocols for recovering movement after resection of STS in the lower limb. Researchers investigated the knee extension strength and postoperative functional outcome after quadriceps resection for soft tissue sarcoma of the thigh. They found that knee extension strength decreased when the number of resected quadriceps increased and this was associated with lower functional scores. They concluded that good functional results can be expected if at least two quadriceps muscles are preserved. However, no detailed assessment of gait in this group of patients has been published.

Assessment of the Functional Outcome and Quality of Life in Sarcoma Patients

To determine the physical and mental health for patients with extremity sarcoma

To measure cancer patients' physical, psychological and social functions

To measure health-related physical activity

Universitaire Ziekenhuizen KU Leuven

Symptoms and General Pathology

Nervous System Diseases

Neoplasm Metastasis

Spinal Cord Neoplasms

Neoplastic Processes

Central Nervous System Neoplasms

Nervous System Neoplasms

Spinal Cord Diseases

Central Nervous System Diseases

-Adult patients admitted to one of the participating centres and treated for ISCM between 2017 and 2023 by resection of the ISCM with or without adjuvant radiotherapy

-Adult patients admitted to one of the participating centres and treated for ISCM between 2017 and 2023 by radiotherapy without resection of the ISCM

Microsurgical resection of ISCM defines the surgical removal of cancerous tumors that have spread to the spinal cord, using advanced microsurgical techniques and equipment like ultrasound, neuromonitoring, ultrasonic aspirator to prevent damage to the spinal cord.

Microsurgical resection of ISCM

Martin N. Stienen, PD, MD

Felix C. Stengel, MD

The aim of the study is to establish a multi-center, retrospective database for patients with intramedullary spinal cord metastases (ISCM) and analyse the functional outcome in surgically treated ISCM patients.

The hypothesis is that the surgical treatment of selected ISCM patients does not lead to persistent morbidity and does not increase mortality, compared to patients that are treated non-operatively.

Secondary objectives are to assess pre- to postoperative neurological deficits, ambulatory status, and overall survival of surgically treated ISCM patients.

The investigators intend to include a control cohort of patients with ISCM from participating centers, who underwent non-surgical oncological treatment (radiotherapy with or without chemotherapy). This control cohort of patients will be used to match patients with and without surgical treatment.

Primary endpoint (analysed in surgically treated ISCM patients):

Functional outcome at 90 days after treatment initiation, measured by the modified McCormick Scale. This is a score for grading of neurological function in spinal cord conditions.

The McCormick scale ranges from Grade I (neurologically intact) to grade V (paraplegic or quadriplegic). The McCormick scale is suitable for our retrospective study because of its good reproducibility and comparability.

Secondary endpoints (analysed in surgically treated ISCM patients and analysed in matched patients with and without surgical treatment):

* Functional outcome by the McCormick scale and the modified Japanese Orthopaedic Association scale (mJOA) at 6 and 12 months. This is a score evaluating motor function of upper and lower extremities, sensory function of upper extremities and sphincter function / voidance. The mJOA ranges from 0 - 18 points, with higher score values representing better functional outcome. The minimum clinically important difference of the mJOA is 1-2 points, and scores lower than 14 indicate moderate myelopathy, scores lower than 11 indicate severe myelopathy.
* Ambulatory status and continence at 90 days, 6 \& 12 months (determined by mJOA subscores)
* Neurological outcome, measured by American Spinal Cord Injury Association (ASIA)
* Impairment Scale at 90 days, 6 and 12 months
* Rate \& type of complications at 90 days after treatment according to The Novel Therapy
* Disability-Neurology Grade (TDN grade)16
* Overall survival (in days)

Microsurgical Resection of Intramedullary Spinal Cord Metastases

Microsurgical Resection of Intramedullary Spinal Cord Metastases - a Retrospective International Multicenter Study

measured by the modified McCormick Scale. This is a score for grading of neurological function in spinal cord conditions.

The McCormick scale ranges from Grade I (neurologically intact) to grade V (paraplegic or quadriplegic). The McCormick scale is suitable for our retrospective study because of its good reproducibility and comparability.

modified Japanese Orthopaedic Association Score (mJOA) Range 0-18, with lower scores indicate a more sever myelopathy

measured by American Spinal Cord Injury Association (ASIA) Impairment Scale (AIS) A: Complete. No sensory or motor function is preserved in sacral segments S4-S5, no sacral sparing B: Sensory Incomplete. Sensory but not motor function is preserved below the neurological level and includes sacral segments S4-S5, AND No motor function is preserved more than three levels below the motor level on either side of the body C: Motor Incomplete. Motor function is preserved below the neurological level AND More than half of the key muscle functions below the neurological level of injury have a muscle grade of less than 3 (Grades 0-2) D: Motor Incomplete. Motor function is preserved below the neurological level AND At least half (half or more) of the key muscle functions below the neurological level of injury have a muscle grade ≥ 3 E: Normal. If sensation and motor function are graded as normal in all segments AND the patient had prior SCI-related deficits

Therapy-Disability-Neurology Grade (TDN Grade) Range: Grade 1-5 The Therapy-Disability-Neurology (TDN) grading system is a novel multidimensional classification of complications severity.

higher Grades indicate higher severity of complication

University Hospital, Zürich

Insel Gruppe AG, University Hospital Bern

University Hospital, Geneva

Kantonsspital Aarau

Kantonsspital Winterthur KSW

Luzerner Kantonsspital

Klinikum rechts der Isar Technische Universität München

University Hospital Muenster

University of Toronto

Stanford University

Cantonal Hospital of St. Gallen

Junior Attending Neurosurgeon

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Erectile Dysfunction

Urinary Incontinence

Enuresis

Urogenital Diseases

Male Urogenital Diseases

Nocturnal Enuresis

Urination Disorders

Urologic Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Lower Urinary Tract Symptoms

Urological Manifestations

Behavioral Symptoms

Elimination Disorders

Mental Disorders

Psychotic Disorders

Genital Diseases

Genital Diseases, Male

Sexual Dysfunction, Physiological

Sexual Dysfunctions, Psychological

Patients that undergo robotic-assisted radical prostatectomy with the use intraoperative nerve monitoring, via electromyography, to identify the exact location of the somatic fibers in the pelvic nerves that seem crucial for urinary continence control and erectile function

Patients that undergo standard of care robotic-assisted radical prostatectomy.

Intraoperative nerve monitoring, via electromyography, enables real-time identification of the location of the somatic fibers in the pelvic nerves that seem crucial for urinary continence control and erectile function.

Intraoperative nerve monitoring,

With out the usage of intraoperative nerve monitoring

standard of care robotic-assisted radical prostatectomy

Jens Sønksen, Dr., Phd, MD

The purpose of this study is to evaluate whether the use of intraoperative nerve monitoring during robotic-assisted radical prostatectomy (RARP) can predict and improve post-surgery urinary continence and erectile function.

Study design:

This is a single center, randomized, single blinded, prospective, clinical trial. The study population will comprise of 100 men that will undergo either a non-nerve sparring or unilateral-nerve sparring RARP. This means that the preoperative evaluation has suggested that it will not be possible to preserve the cavernous parasympathetic nerves lying in the fascia on either side of the prostate gland during surgery (called bilateral-nerve sparring). Despite the term, non-nerve sparring surgery, the surgeon will still attempt to preserve the somatic fibers of the pudendal nerve as best possible. However, due to the extent of cancer tissue the surgeon will generally need to operate closer to the pudendal nerve then when performing bilateral-nerve sparring surgery. So, the somatic fibers of the pudendal nerve are more likely to be severed. The same is the case on one side when performing unilateral surgery.

The treatment group will consist of 50 subjects that will undergo nerve monitoring during RARP. Results will be compared to a control cohort consisting of 50 patients that will undergo contemporary RARP.

Aside from the usage of nerve monitoring in the intervention-group, all procedures and care from admission to the hospital through discharge will be standard of care for subjects in both the control and Intervention-group.

Baseline evaluation and collection of data:

Patients will be screened for eligibility on the phone, and if eligible and they accept they will be scheduled to a visit at the hospital where the following data will be registered for all participants prior to surgery:

* Age at time of surgery
* Known co-morbidity
* Body Mass Index (BMI)
* Medicine status
* Smoking
* Partner status
* Level of education
* Employment Clinical status
* Clinical stage (cT-staging)
* Gleason score
* Prostate specific antigen (PSA)

Prior to surgery participants will also have answered the questionnaires listed either prior to or during the first visit and have undergone an MRI and the bulbocavernosus-reflex test:

* ICIQ (International Consultation on Incontinence Questionnaire) form about incontinence symptoms
* Danish Prostate Symptom Score (DAN-PSS)
* International Prostate Symptom Score (IPSS)
* International Index of Erectile Function (IIEF) score
* Erection Hardness Scale (EHS) score
* Presence or absence of bulbocavernosus-reflex. The physician test for this by shortly squeezing the penis while observing if the urethra retracts or the anal sphincter contracts. The test is not painful and only takes a few seconds.
* Magnetic Resonance Imaging (MRI) scan with measurements of the urethral length and width, and prostate volume along with other specific anatomical structures in relation to the urethra. Contrast agents will not be applied.

Intraoperative data:

* Contraction of the sphincter musculature during stimulation via the nerve monitoring system before removal of the prostate gland
* Contraction of the sphincter musculature during stimulation via the nerve monitoring system after removal of the prostate gland.
* Blood loss
* Non- or unilateral nerve sparring
* Lymph node dissection
* Total surgical time
* Sphincter lesion
* The surgeon's subjective prediction whether the patient will return to continence postoperatively

During the procedure, through discharge and before follow-up regime begins, the following data points will be collected:

* Time to removal of catheter
* Leakage of the anastomosis
* Stricture.
* Other adverse effects
* Pathologic cancer stage (pT-stage)
* Pathologic Gleason score
* Status of surgical margins

Follow-up evaluation.

Subjects will be evaluated 14 days after catheter removal and at standard clinical controls at 3, 6 and 12 months. The following questionnaires are answered at every visit:

* International consultation on Incontinence Questionnaire (ICIQ) for incontinence,
* Danish Prostate Symptom Score (DAN-PSS)
* International Prostate Symptom Score (IPSS)
* International Index of Erectile Function (IIEF) and Erection Hardness Scale (EHS).

During the last 3 visits subjects also answers a fluid intake/output questionnaire and hand in the results of a 24-hour pad test. In addition to the questionnaires the patients will also undergo an MRI and a bulbocavernosus reflex test 12 months postoperative.

Intraoperative Nerve Monitoring During Robotic-assisted Radical Prostatectomy

Can Intraoperative Nerve Monitoring Predict and Improve Functional Outcomes After Robotic-assisted Radical Prostatectomy

Difference in total International consultation on incontinence questionnaire (ICIQ)-score between the 2 groups after a follow-up of 1 year.

ICIQ is a self-reported survey and screening tool for incontinence. It consists of 3 questions regarding symptoms in the past 4 week, with an overall 0-21 score, where greater values indicate increased severity. Question 1 scores from 0-5, question 2 scores either 0,2,4 or 6 and question 3 scores from 0-10. Only the total score is evaluated. Furthermore there is 1 self-diagnostic question.

Difference in erection rates and sexual activity between the 2 groups after 12 months. Sexual activity defined as yes to the question "Within the last 3 months, have you been sexually active and attempted intercourse?" Erection is defined as a score of at least 17 on the IIEF-5 form and or a score of a least 3 on the EHS form with the use of either no assistance phosphodiesterase 5 inhibitors

Correlation between nerve signal prior to removal of the prostate and preoperative urinary function

Correlation between nerve signal prior to removal of the prostate and preoperative erectile function

Correlation between nerve signal after removal of the prostate and postoperative urinary function

Correlation between nerve signal after removal of the prostate and postoperative erectile function

Difference in Time to continence between the two groups

Herlev and Gentofte Hospital

Digestive System Diseases

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Diverting ileostomy

Quan Wang, Prof.

Weihua Tong

Analyze the occurrence of complications, rectal function and quality of life after anus-preserving surgery for middle and low rectal cancer, so as to evaluate the role of protective ileostomy.

Diverting Ileostomy and Anal Functional Outcomes After Anus Preservation Surgery

A Prospective Registration Study on Diverting Ileostomy and Anal Functional Outcomes After Anus Preservation Surgery in Middle and Low Rectal Cancer

Postoperative complications based on Clavien-Dindo

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Assessment of the Functional Outcome and Quality of Life in Sarcoma Patients	NCT05051059	Soft Tissue Sar... Bone Sarcoma	Functional outc... Health related ...	18 Years - 95 Years	Universitaire Ziekenhuizen KU Leuven
Microsurgical Resection of Intramedullary Spinal Cord Metastases	NCT06042946	Spinal Cord Met... Spinal Cord Tum... Functional Outc... Radiotherapy; C... Spinal Cord Neo...	Microsurgical r...	18 Years -	Cantonal Hospital of St. Gallen
Intraoperative Nerve Monitoring During Robotic-assisted Radical Prostatectomy	NCT03721029	Humans Urinary Inconti... Male Urogenital... Prostatectomy Erectile Dysfun...	Intraoperative ... standard of car...	-	Herlev and Gentofte Hospital
Diverting Ileostomy and Anal Functional Outcomes After Anus Preservation Surgery	NCT04776421	Diverting Ileos... Middle and Low ... Functional Outc... Stoma Complicat...	Diverting ileos...	18 Years - 75 Years	The First Hospital of Jilin University
Intraoperative Nerve Monitoring During Robotic-assisted Radical Prostatectomy	NCT03721029	Humans Urinary Inconti... Male Urogenital... Prostatectomy Erectile Dysfun...	Intraoperative ... standard of car...	-	Herlev and Gentofte Hospital

Spots Global Cancer Trial Database for functional outcome