Research Project Annual Report

Lead investigator / Dale Vimalachandran / Institution / Countess of Chester NHS FT
Project Title / HiP Study: Hartmann’s Procedure versus
Start date / April 2015 / Finish date / April 2108
Lay Summary, including background, methods, results and conclusions to date
(max 1000 words) / There are a number of occasions where patients will require surgical removal of their rectum. This is usually performed for colorectal cancer, but in some instances may be performed for inflammatory diseases.
Restoration of gastrointestinal continuity can be achieved by joining the colon to the anal canal. This is a technically challenging procedure and can be associated with significant complications, the most serious of which is a leak from the join. Such leaks can occur in up to 10% of patients and can be fatal in patients who are not medically fit. In instances where a patient is deemed to be high risk due to other medical conditions or it is felt that the functional outcome will be poor, many surgeons elect not to perform a join and bring the upstream bowel out as a permanent colostomy. The top of the anal canal is generally stapled off in these cases, in an operation known as an ultra-low Hartmann’s procedure.
Whilst this procedure avoids the complication of a leak and its attendant problems, evidence exists to suggest that it is not without complication. The most common problem occurs due to leak of the staple line at the top of the anal canal, and this can lead to a pelvic abscess. An alternative procedure that avoids this risk by removing the anal canal altogether (intersphincteric APE) may be performed, although this has the disadvantage of leaving a wound between the legs.
There is some evidence to suggest that the intersphincteric APE results in less pelvic abscesses and thus a reduced need to re-intervene and ultimately a shorter stay in hospital. This is at the expense of a slightly longer operating time and a second wound between the legs.
The current available evidence does not help surgeons decide which is the best procedure for patients in this setting. The proposed study would compare these two operations when surgeons feel that they cannot safely perform a join for patients undergoing removal of the rectum.
Having established a network of units (UK and Europe) who are also keen to answer this question we have powered a prospective observational cohort study to demonstrate a significant reduction in surgical complication rate (30% to 15%). In conjunction with an on going Swedish randomised trial we hope that the data from this study will provide compelling evidence for UK surgeons to change practice. If the study reveals only a modest difference in complications, we will use the data gathered to design and reapply again for full funding for an RCT with the additional advantage of being able to clearly demonstrate a network of units capable of recruiting the necessary number of patients. The overarching aims of this study are therefore to:
1.  DDetermine the difference in surgical complication rates between HP and IAPE
2.  AAssess the effect of IAPE technique on intra operative tumour perforation rate
The objectives of the study are to:
1.  DDetermine surgical complication rate for each procedure (graded by Clavien-Dindo)
2.  AAssess impact on secondary outcomes (length of stay, readmission, reintervention, medical complications, time to chemotherapy, quality of life)
3.  DDetermine if the complication rate in IAPE is dependant on surgical technique
4.  DDetermine patient and clinician acceptability to randomisation if required
Data Collection
Data will be collected on specific CRF at baseline and 30 post operative days, all data will be completely anonymised and no further data will be collected past 30 days. The easy to use and well validated Clavien-Dindo scale will be use to grade surgical complications, but we will also calculate the Comprehensive Complication Index which integrates all medical and surgical complications and is felt to represent a more accurate estimation of post operative complications (4). Data will be collected at the following time points
BASELINE / INTRAOPERATIVE / POST OPERATIVE (30 days)
Age / Surgical approach (lap, open) / Pathological stage
Sex / Anaesthetic type / TME quality
BMI / Operative time / Length of stay
Comorbidities / Intra operative perforation / Readmission
ASA score / Length of anorectal stump (HP) / Surgical complications (Clavien-Dindo scale)
Radiological stage / Antibiotics / Medical complications
Distance of tumour from anal verge / Method of IAPE (one vs two stage) / Comprehensive Classification Index score
Preoperative therapy / 30 day quality of life
Quality of life / Patient willingness to randomise
Reason for avoiding primary anastomosis / Surgeon willingness to randomise
Surgeon’s reason for op choice
Progress to date:
The study officially opened in March 2016, we have expressions of interest from 40 UK sites and to date there are 9 UK sites and 1 international site in Spain open. Five patients have been recruited and it is hoped over the next 6 months the remaining sites will be opened. The study is on the NIHR portfolio and this has resulted in further interest and site recruitment in addition to the original trial presentations.


Changes to protocol from proposed project / None to date, other than minor typographical amendments
Aims of project / Determine the difference in surgical complication rates between HP and IAPE
Progress made to date / 5 patients recruited from 10 active sites.
Successes with the project in the last year / Significant increase in site interest as a result of having the study on the NIHR portfolio
Difficulties with the project in the last year / Transition from CSP to HRA for study approval has caused a significant delay in registering new sites. The trial coordinator at the Northwest Surgical Trial Centre originally was trying to open sites whilst running a number of studies, this issue has now been resolved and he is able to devote more time to opening sites which should speed up recruitment.
Timescales and milestones for the project in the next year / Over the next 12 months open all remaining sites and have at least 1 patient per site recruited. Further develop European collaborations to open more European sites.
Publications and presentations to date / None to date other than trial advertisement.