Hartmann's procedure versus intersphincteric APE: a prospective study
Research type
Research Study
Full title
Hartmann's type procedure versus intersphincteric APE in patients undergoing resection of rectal cancer in whom restoration of gastrointestinal continuity is not appropriate: a multi centre, prospective observational study
IRAS ID
171568
Contact name
Dale Vimalachandran
Contact email
Sponsor organisation
Countess of Chester NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
More than 41 000 new cases of bowel cancer are diagnosed annually in the UK with one third occurring in the rectum. Standard treatment for rectal cancer is an operation that removes the section of bowel containing the tumour, reconnecting healthy bowel to the anal canal. This reconstructive approach allows patients to defecate normally, but is associated with a relatively high rate of perioperative complications (40%) and poor bowel function (50%). Where these risks are unacceptably high (frail patients, multiple comorbidities, poor pelvic floor/anal canal function) alternative non-reconnecting strategies are substituted.
Hartmann’s procedure (HP) has been regarded as the non-reconnecting operation of choice and is technically quite straightforward. Alternatively, another operation called IAPE completely removes all of the rectum and anal canal which is thought to significantly reduce the incidence of serious pelvic infection that may with HP. Some surgeons are reluctant to perform this procedure due to the slightly increased operating time and the risk of the local wound failing to heal.
It is unclear which is the best procedure, and there are no prospective data to guide surgeons. This is a prospective observational study of patients undergoing these two procedures, a formal RCT is not possible at the present time due to uncertainty over patient numbers and feasibility of randomisation.
The primary objectives are to establish the use of each procedure and determine the surgical complication rate associated with each. This prospective data may be sufficient to determine the optimal procedure, if not it will be used to inform the design of a larger prospective randomised trial. We will also assess whether patients and surgeons would be willing to recruit to such a study also. The study will incorporate centres from across the UK as well as European and worldwide centres who are also interested in answering this question.
REC name
North of Scotland Research Ethics Committee 2
REC reference
15/NS/0093
Date of REC Opinion
25 Aug 2015
REC opinion
Further Information Favourable Opinion