Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Postoperative Complications

Noncommunicable Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Disease Attributes

David Ljungman, MD PhD

Stina Lindholm, MD

Sofia Lindskogen, MD

Göran Kurlberg, Asoc prof

Bawantha Gamage, MD

To test the applicability of the Clavien-Dindo Classification (CDC) in an LMIC setting and to compare the prevalence and severity of complications in patients \<60 and ≥60 years of age a retrospective medical records review is used.

Background: Colorectal cancer (CRC) is increasing in Low- and Middle-Income Countries (LMIC) as part of the ongoing epidemiological transition. Surgery is the main treatment and the global health agenda is increasingly putting focus on improving the safety and quality of surgical care in low-resource settings. The current systems for measuring surgical quality are mainly customized for high-income countries.

Aim: To test the applicability of the Clavien-Dindo Classification (CDC) in an LMIC setting. Additionally, to compare the prevalence and severity of complications in patients \<60 and ≥60 years of age.

Material and methods: Retrospective medical records review for postoperative complications and severity grading using the CDC.

Measuring Quality in Colorectal Cancer Surgery in Low- and Middle-income Countries

Measuring Quality in Colorectal Cancer Surgery in Low- and Middle-income Countries: the Clavien-Dindo Classification in a Sri Lankan Cohort

Postoperative complications graded by the Clavien-Dindo Classification.

Comparison of prevalence and severity of complications between patients \<60 and ≥60 years of age.

Sahlgrenska University Hospital, Sweden

Consultant surgeon

Infections

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Communicable Diseases

Papillomavirus Infections

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

Virus Diseases

DNA Virus Infections

Tumor Virus Infections

Genital Diseases

Urogenital Diseases

All Drugs and Chemicals

Vaccines

Healthy females aged 10 years and above will receive 1, 2 or 3 doses of Cervarix as per the Prescribing Information (PI) in Sri Lanka.

Safety monitoring: recording of all AEs during the study period using diary cards, follow-up visit or telephone contact.

Cervarix data collection

All adverse events will be recorded by diary card, follow-up visit or telephone contact.

Data Collection

GSK Clinical Trials

This PMS study aims to collect safety and reactogenicity data of Cervarix in the local population as per the licensing requirement of the Sri Lankan regulatory authority.

Subjects who received one or two doses of Cervarix prior to the start of this PMS study can also be enrolled in the study. These subjects would receive either 2 doses or 1 dose respectively after being enrolled in the study.

Since there is lack of clarity regarding the PMS study requirement (both from Regulatory agency and Ethics Committee), it was decided that GSK will submit Local PSURs on a regular basis as desired by Local regulatory agency. The same is communicated to Regulatory agency and if they want something more they are requested to revert back with specific requirements.

Post-marketing Surveillance of GSK Biologicals' Cervarix™ When Administered to Healthy Females in Sri Lanka

Post-marketing Surveillance (PMS) of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) -16/18 Vaccine, Cervarix™ When Administered to Healthy Females According to the Prescribing Information in Sri Lanka

GlaxoSmithKline

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Measuring Quality in Colorectal Cancer Surgery in Low- and Middle-income Countries	NCT05182762	Colorectal Canc... Postoperative C... Surgical Compli... Non-communicabl...		-	Sahlgrenska University Hospital, Sweden
Post-marketing Surveillance of GSK Biologicals' Cervarix™ When Administered to Healthy Females in Sri Lanka	NCT01551537	Human Papilloma...	Cervarix data c... Data Collection	10 Years -	GlaxoSmithKline

Spots Global Cancer Trial Database for sri lanka

Every month we try and update this database with for sri lanka 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.

Spots Global Cancer Trial Database for sri lanka

Every month we try and update this database with for sri lanka 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.

Every month we try and update this database with for sri lanka 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.