Anterior Resection Syndrome Following Sphincter-preserving Surgery

NCT02190656 | Completed

• 1 other identifier: 009515
• Study Type: observational
• Target: 1,197
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rectal Cancer

Keywords

Rectal cancer; Anterior Resection Syndrome; Functional outcomes

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Correlation between LARS score and EORTC QLQ-C30 questionnaire score

  At the time of questionnaire completion

Other Outcomes (2)

• LARS score in different age groups

  At time of questionnaire completion

• LARS score in participants who have had laparoscopic surgery and participants who have had open surgery

  At time of questionnaire completion

Study Arms (1)

Anterior resection

Patients having had an anterior resection for rectal cancer who are more than 12 months post surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients having had an anterior resection for rectal cancer who are more than 12 months post surgery

You may qualify if:

• 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

You may not qualify if:

• Presence of a stoma
• Local recurrence of cancer
• Current adjuvant therapy
• Further rectal surgery after the initial operation
• Insufficient written English to participate

Sponsors & Collaborators

• Queen Mary University of London: lead
• The Royal College of Surgeons of England: collaborator

Study Sites (1)

Queen Mary University of London

London, E1 2AT, United Kingdom

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Mohamed Thaha, PhD FRCS

  Queen Mary University of London

  STUDY CHAIR

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2014
• First Posted: July 15, 2014
• Study Start: May 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: September 1, 2015
• Last Updated: April 5, 2016

Record last verified: 2016-04

Locations

GB (1)