Neoplasms

Digestive System Diseases

All Conditions

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Colorectal Neoplasms

Nasopharyngeal Neoplasms

Urologic Neoplasms

Mouth Neoplasms

Urologic Diseases

Otorhinolaryngologic Diseases

Oropharyngeal Neoplasms

Laryngeal Neoplasms

Hypopharyngeal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Urogenital Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Laryngeal Diseases

Respiratory Tract Diseases

Respiratory Tract Neoplasms

Mouth Diseases

Oral Cancer

A single port innovation designed to deliver an articulating 3D high definition camera and three fully articulating instruments through a single 25-mm cannula

Robotic single port colorectal surgery; Robotic transanal surgery; Robotic single port urologic surgery; Transoral robotic surgery

Robotic single port surgery and NOTES

This is a prospective, single center, multispecialty study that aimed to evaluate the clinical feasibility and safety of single port surgery and NOTES (mainly transanal and transoral surgery) using a novel single port robotic system.

Background: Single port surgery and natural orifice transluminal endoscopic surgery (NOTES) are emerging minimally invasive surgery techniques which can further reduce patient trauma and enhance recovery. However, the wider adoption of these techniques is hampered by the limitation of instrumentation and technical difficulties. Robotic assistance may improve surgical capabilities during single port surgery and NOTES by providing augmented motion precision and manipulation dexterity.

Objectives: To evaluate the clinical feasibility and safety of single port surgery and NOTES (mainly transanal and transoral surgery) using a novel single port robotic system.

Design: Prospective, single center, multispecialty study consistent with a stage 1 (Innovation) study described in the Innovation, Development, Exploration, Assessment, Long-term Study (IDEAL) framework.

Subjects: Sixty consecutive patients with various benign/malignant pathologies indicated for single port colorectal/urologic surgery or transanal/transoral surgery who fulfilled all the inclusion and exclusion criteria will be recruited.

Intervention: Single port surgery and transanal/transoral surgery will be performed using the novel single port robotic system.

Study Endpoints: Primary: conversion rate and perioperative complications. Secondary: operative time, blood loss, pain scores, analgesic requirement, and length of stay.

Hypothesis: The prospective study will provide important information on the feasibility, safety, and effectiveness of the novel single port robotic system in performing single port surgery and NOTES in various surgical specialties. A positive study will provide supporting evidence for continuing development of this new technology.

A Novel Robotic System for Single Port and Natural Orifice Transluminal Endoscopic Surgery

A Novel Robotic System for Single Port and Natural Orifice Transluminal Endoscopic Surgery: A Prospective, Single Center, Multispecialty Study

An emergent change in the treatment plan to conventional minimally invasive (laparoscopic/endoscopic) surgery (i.e. the use of more than one additional port), multiport robotic surgery, or to open surgery

Complications including intraoperative complications and all complications occurring during the hospital stay or within 30 days after discharge will be graded according to the Clavien-Dindo classification

Pathologic examination of the resected specimen for completeness of resection

Pathologic examination of the resected specimen for resection margins positivity

Pathologic examination of the resected specimen (malignant cases)

After transanal surgery; using the Cleveland Clinic Incontinence Score (Wexner's Score)

After transanal surgery; using the validated Chinese version of the Fecal Incontinence Quality of Life Scale (FIQL)

After radical prostatectomy; assessed by recording the number of pads used per day

After radical prostatectomy; using the abridged version of the International Index of Erectile Dysfunction - erectile function domain score (IIEF-EF)

After nephrectomy; using renal function blood tests for urea and creatinine

After TORS; using the MD Anderson Dysphagia Inventory

After TORS; using the Voice Handicap Index (VHI) 30

Chinese University of Hong Kong

Professor of Surgery

Carcinoma

Carcinoma, Squamous Cell

Lip and Oral Cavity Cancer

Antineoplastic Agents

All Drugs and Chemicals

Cisplatin

Preoperative chemotherapy with concurrent radiotherapy followed by definitive surgery

Three weekly concurrent chemotherapy with cisplatin 100 mg /m2

Neoadjuvant chemotherapy

Preoperative radiotherapy over 5 weeks- Dose 180-200cgys per day/ total 4500 cgys

Neoadjuvant radiotherapy

Resection and reconstruction of mandibular/maxillary segment with prefabricated fibular graft

Resection and reconstruction

Sanjay Deshmukh, MS

Oral cancer is the single largest cancer in males in India. 90-95% cases of oral cancer are Squamous cell carcinomas and many of them present at late stages (T3 and above). Treatment of OSCC includes single modality surgery, radiotherapy, or combinations of these modalities with or without systemic therapy. For unresectable cases, radiotherapy and/or chemotherapy is the treatment modality. Efficacy of neoadjuvant chemoradiotherapy for resectable stage IV tumors (late stage) needs to be evaluated to assess its benefit before surgery.

This study will assess the benefit of preoperative adjuvant chemoradiotherapy in patients with an Stage IVa oral squamous cell carcinoma (OSCC). The study population will consist of patients who have not been treated previously. Patients satisfying the inclusion-exclusion criteria will be included in the study after obtaining a valid, written and informed consent. After reviewing the histopathological report, the patients will be treated as per the study protocol. The patients will be under regular follow-up with 3 monthly intervals for a period of one year and 6 monthly period in the following years. At each follow-up, patients will be evaluated clinically for evidence of locoregional tumor recurrence. The locoregional recurrence-free survival will be calculated based on the difference between the date of inclusion and the date of biopsy-proven recurrence. We will also record the overall survival, parameters like trismus, osteonecrosis and xerostomia. Quality of life will be assessed at a regular interval of 1 year using the University of Washington Quality of Life Questionnaire (UW-QOL v.4)

Study protocol:

1. Preoperative radiotherapy over 5 weeks- Dose 180-200cgys per day/ total 4500 cgys
2. Three weekly concurrent chemotherapy with cisplatin 100 mg /m2
3. Initial surgery in leg for Prefabrication of fibula - 2 weeks after starting of radiotherapy treatment. Delay is required for planning of implant position in the fibula.
4. Definitive surgical procedure with reconstruction by prefabricated flap, 6 weeks post radiotherapy.

Adjuvant ChemoRadiotherapy Prior to Surgery in Stage IVa Oral Cancers

Assessing Efficacy of Neoadjuvant Chemoradiotherapy as a Treatment Plan for Patients With Stage IVa Oral Cancer.

Individual patient data for all primary and secondary outcomes will be made available.

This will be deduced from pathological response in terms of complete and partial response. Complete response is defined as no invasive and no in situ residuals present in the surgical specimen. Partial response defined as at least a 30% reduction in the size of the lesion in the surgical specimen.

Disease-free survival will be calculated as the time interval (months) between primary treatment and the first recurrence (whether local, regional or distant).

Overall Survival will be calculated as the time interval (months) between primary treatment and death.

Patient reported quality of life will be assessed at a regular interval of 1 year using the University of Washington Quality of Life Questionnaire (UW-QOL v.4). The minimum score is 0 which is indicative of worse outcome while 100 is the maximum score and indicative of better outcome. Various parameters including chewing, pain, swallowing, saliva, appearance etc. are included in the questionnaire. Average score for each parameter with standard deviation will be reported.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Novel Robotic System for Single Port and Natural Orifice Transluminal Endoscopic Surgery	NCT03010813	Colorectal Neop... Urologic Neopla... Urologic Diseas... Nasopharyngeal ... Oropharyngeal N... Oral Neoplasms Hypopharyngeal ... Laryngeal Neopl... ENT Diseases	Robotic single ...	18 Years -	Chinese University of Hong Kong
Adjuvant ChemoRadiotherapy Prior to Surgery in Stage IVa Oral Cancers	NCT03923998	Squamous Cell C...	Neoadjuvant che... Neoadjuvant rad... Resection and r...	18 Years - 70 Years	Indrayani Hospital and Cancer Institute

Spots Global Cancer Trial Database for oral neoplasms