Hartmann's Versus Intersphincetric APE: A Prospective, Multicentre Study

NCT02702089 | Unknown

• 1 other identifier: Surg05/15
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

14,000 new cases of rectal cancer are diagnosed each year, frail and elderly patients represent a rising proportion of these patients. Whilst the gold standard is often to remove the tumour and restore bowel continuity, surgeons will often avoid this procedure in this group of patients as they unfortunately tolerate surgical complications very poorly. Such surgical complications may present with life threatening sepsis, can prolong hospital stay, delay further cancer therapy and in the elderly or frail patient often leads to loss of independence and quality of life. In this setting, there are two alternative procedures (Hartmann's procedure OR intersphincteric APE) that may be used and these are employed in roughly equal measure in the UK (nationwide survey, Dec 2013, unpublished data). It is anecdotally felt that Hartmann's procedure (HP) has a greater risk of surgical complications (30%) and a few small retrospective studies have shown this (1-3), however there are no prospective data to support this view. Whilst some surgeons do choose intersphincteric APE (IAPE) on the basis of a lower surgical complication rate, many do not due to perceived limitations in the technique (longer operating time, risk of tumour perforation), which are unproven. We feel that a larger, prospective dataset is required to demonstrate the superiority of IAPE over HP and convince the remaining surgeons to change procedure. We have explored the possibility of a full randomised trial to answer this question, however this is not feasible due to the difficulty of randomisation of patients. Very little data are available regarding the use of IAPE in the setting of rectal cancer, however many surgeons who do employ the technique, specifically adapt their technique in this setting to reduce the chances of tumour perforation (two stage, stapling off rectum before removing anal canal separately). It is possible that those surgeons who prefer HP have not considered this, and combined with the lack of prospective data are reluctant to change technique. We are confident that if we can demonstrate a significant difference in surgical complication rate and promote a modification to the IAPE surgical technique then we can significantly reduce surgical harm to these frail patients.

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• morbidity

  30 days

Secondary Outcomes (5)

• Quality of life

  90 days

• Length of stay

  90 days

• Readmission rate

  90 days

• Time to chemotherapy

  90 days

• Reintervention rate

  90 days

Study Arms (2)

IAPE

Intersphincteric AP excision

Procedure: Rectal cancer surgery

HP

Hartmann's procedure

Procedure: Rectal cancer surgery

Interventions

Rectal cancer surgery PROCEDURE

Rectal cancer resection

HP; IAPE

Eligibility Criteria

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

Study Population

Frail patients with rectal cancer

You may qualify if:

• Patients aged over 18 years
• Able to provide informed consent
• Undergoing elective, locally curative surgery for rectal cancer
• Recurrent rectal cancer not a contraindication if pre operative imaging suggests that the tumour can be removed with clear margins
• Primary anastomosis not appropriate for reasons of frailty, poor function or risks of anastomotic leak
• Local staging completed by MRI
• Histological confirmation of adenocarcinoma
• Fit for major resection

You may not qualify if:

• Pregnant patients
• Patients unable to consent
• Local palliative resection (systemic metastatic disease not a contraindication)
• Suspicion of tumour perforation
• Rectal tumours requiring a formal APE due to distal tumour involvement of anorectal junction or pelvic floor

Sponsors & Collaborators

• Countess of Chester NHS Foundation Trust: lead

Study Sites (1)

Countess of Chester Hospital

Chester, Cheshire, CH2 1UL, 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 Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Surgeon

Study Record Dates

• First Submitted: March 3, 2016
• First Posted: March 8, 2016
• Study Start: March 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2019
• Last Updated: March 8, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)