Abstract
BackgroundThe use of Hartmann’s procedure in the old and frail and/or in patients with fecal incontinence is increasing, even though some data have reported high postoperative rates of pelvic abscesses. Abdominoperineal excision with intersphincteric dissection has been proposed as a better alternative and is performed increasingly both nationally and internationally. However, no studies have been performed to support this. The aim of this study is to randomize patients between Hartmann’s procedure and abdominoperineal excision with intersphincteric dissection and compare post-operative surgical morbidity and quality of life. The hypothesis is that intersphincteric abdominoperineal excision provides less pelvic and perineal morbidity.Methods/designIn this multicentre randomized controlled study, Hartmann’s procedure will be compared with intersphincteric abdominoperineal excision in patients with rectal cancer unsuitable for an anterior resection. The patients are operated in different ways around the ano-rectum, otherwise the same procedure is performed with total mesorectal excision and all will receive a colostomy. The one-month postoperative control will focus on post-operative surgical complications, especially the perineal-pelvic, reoperations and other interventions. After one year, late complications such as pain in the perineal or pelvic area or disorders such as secretion or bleeding from the anorectal stump will be recorded and a follow-up of quality of life performed. Histological and oncological data will also be recorded, the latter up to 5 years post-operatively.DiscussionThe HAPIrect trial is the first randomized controlled trial comparing standard low Hartmann’s procedure with intersphincteric abdominoperineal excision in patients with rectal cancer with the aim of categorizing the post-operative surgical morbidity.Trial registrationClinicalTrials.gov Identifier: NCT01995396. Date of registration November 25, 2013.
Highlights
The use of Hartmann’s procedure in the old and frail and/or in patients with fecal incontinence is increasing, even though some data have reported high postoperative rates of pelvic abscesses
Hartmann’s procedure (HP) has been increasingly used in the old and frail to reduce the risk of a life-threatening complication such as an anastomotic leakage with fecal peritonitis, and/or to avoid crippling problems with fecal incontinence after an anterior resection
In patients with metastases there has been an increase in performing a HP with the intention of avoiding severe post-operative surgical complications so that post-operative chemotherapy can be started as soon as possible [4]
Summary
The use of Hartmann’s procedure in the old and frail and/or in patients with fecal incontinence is increasing, even though some data have reported high postoperative rates of pelvic abscesses. Abdominoperineal excision with intersphincteric dissection has been proposed as a better alternative and is performed increasingly both nationally and internationally. The aim of this study is to randomize patients between Hartmann’s procedure and abdominoperineal excision with intersphincteric dissection and compare post-operative surgical morbidity and quality of life. In patients with rectal cancer, low anterior resection (LAR) with total mesorectal excision (TME) is standard procedure [1]. Reasons for the high rate of pelvic complications in previous studies might be the selection of unfit patients with reduced vascular blood supply, even more pronounced after the low HP. The broadest possible transverse stapler that fits into the pelvis in order to avoid tension in the stapler line (mostly 45 and 60 mm), has been proposed [7]
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