Rectal Cancer Clinical Trial
Official title:
Anterior Resection Syndrome Following Sphincter-preserving Surgery
Verified date | April 2016 |
Source | Queen Mary University of London |
Contact | n/a |
Is FDA regulated | No |
Health authority | United Kingdom: Research Ethics Committee |
Study type | Observational |
Bowel cancer is the third most common cancer in the UK in both males and females. The rectum
is the most commonly affected part of the bowel. Improvements in surgery have meant that
many patients with rectal cancer can now undergo surgery that removes the rectum and avoids
a permanent stoma. The operation that most patients have is an anterior resection of the
rectum.
Unfortunately this surgery frequently leads to a change in bowel function, with patients
suffering from incontinence, urgency and unpredictability a problem known as anterior
resection syndrome. These problems are believed to be fairly common following surgery but
follow up appointments have traditionally concentrated on ensuring that the cancer has not
returned and have not reviewed functional outcomes in enough detail. Because of this we are
unsure exactly how common the problems described are.
The proposed study will allow us to determine how many patients have ongoing symptoms
following their surgery for rectal cancer. It will also allow us to use a newly developed
scoring system the Low Anterior Resection Syndrome (LARS) score for the first time in a UK
population, to ensure that it can accurately be used in the future to measure the problem
and aid development of new therapies. An appreciation of the impact of symptoms on
postoperative quality of life will encourage routine assessment of functional outcomes in
clinical practice, allowing identification of patients who may benefit from treatment.
Status | Completed |
Enrollment | 1197 |
Est. completion date | September 2015 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients having had an anterior resection for rectal cancer who are more than 12 months post surgery - Patients who are more than 12 months post reversal of any defunctioning stoma - Aged over 18 years Exclusion Criteria: - Any inclusion criteria not met - Presence of a stoma - Local recurrence of cancer - Current adjuvant therapy - Further rectal surgery after the initial operation - Insufficient written English to participate |
Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
United Kingdom | Queen Mary University of London | London |
Lead Sponsor | Collaborator |
---|---|
Queen Mary University of London | The Royal College of Surgeons of England |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | LARS score in different age groups | At time of questionnaire completion | No | |
Other | LARS score in participants who have had laparoscopic surgery and participants who have had open surgery | At time of questionnaire completion | No | |
Primary | Number of participants with no LARS; minor LARS and major LARS | This will allow us to determine the prevalence of Low Anterior Resection Syndrome | At the time of questionnaire completion | No |
Secondary | Correlation between LARS score and EORTC QLQ-C30 questionnaire score | The association between the LARS score and The European Organization for Research and Treatment of Cancer (EORTC) generic quality of life questionnaire QLQC30 will be used to establish validity of the LARS score. Ability of the score to differ between patient groups known to differ in postoperative function (for example, those who have had radiotherapy and those who have not) will also be used to assess validity. | At the time of questionnaire completion | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06380101 -
Evaluating a Nonessential Amino Acid Restriction (NEAAR) Medical Food With Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer (LARC)
|
N/A | |
Active, not recruiting |
NCT05551052 -
CRC Detection Reliable Assessment With Blood
|
||
Recruiting |
NCT04323722 -
Impact of Bladder Depletion on Mesorectal Movements During Radiotherapy in Rectal Cancer
|
N/A | |
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT04088955 -
A Digimed Oncology PharmacoTherapy Registry
|
||
Active, not recruiting |
NCT01347697 -
Collagen Implant (Biological Mesh) Versus GM Flap for Reconstruction of Pelvic Floor After ELAPE in Rectal Cancer
|
N/A | |
Recruiting |
NCT04495088 -
Preoperative FOLFOX Versus Postoperative Risk-adapted Chemotherapy in Patients With Locally Advanced Rectal Cancer
|
Phase 3 | |
Withdrawn |
NCT03007771 -
Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia
|
Phase 1 | |
Terminated |
NCT01347645 -
Irinotecan Plus E7820 Versus FOLFIRI in Second-Line Therapy in Patients With Locally Advanced or Metastatic Colon or Rectal Cancer
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT03520088 -
PROSPECTIVE CONTROLLED AND RANDOMIZED STUDY OF THE GENITOURINARY FUNCTION AFTER RECTAL CANCER SURGERY IN RELATION TO THE DISSECTION OF THE INFERIOR MESENTERIC VESSELS
|
N/A | |
Recruiting |
NCT05556473 -
F-Tryptophan PET/CT in Human Cancers
|
Phase 1 | |
Recruiting |
NCT04749381 -
The Role of TCM on ERAS of Rectal Cancer Patients
|
Phase 2 | |
Enrolling by invitation |
NCT05028192 -
Mitochondria Preservation by Exercise Training: a Targeted Therapy for Cancer and Chemotherapy-induced Cachexia
|
||
Recruiting |
NCT03283540 -
Transanal Total Mesorectal Excision for Rectal Cancer on Anal Physiology + Fecal Incontinence
|
||
Completed |
NCT04534309 -
Behavioral Weight Loss Program for Cancer Survivors in Maryland
|
N/A | |
Recruiting |
NCT05914766 -
An Informational and Supportive Care Intervention for Patients With Locally Advanced Rectal Cancer
|
N/A | |
Recruiting |
NCT04852653 -
A Prospective Feasibility Study Evaluating Extracellular Vesicles Obtained by Liquid Biopsy for Neoadjuvant Treatment Response Assessment in Rectal Cancer
|
||
Recruiting |
NCT03190941 -
Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients
|
Phase 1/Phase 2 | |
Completed |
NCT02810652 -
Perioperative Geriatrics Intervention for Older Cancer Patients Undergoing Surgical Resection
|
N/A | |
Terminated |
NCT02933944 -
Exploratory Study of TG02-treatment as Monotherapy or in Combination With Pembrolizumab to Assess Safety and Immune Activation in Patients With Locally Advanced Primary and Recurrent Oncogenic RAS Exon 2 Mutant Colorectal Cancer
|
Phase 1 |