Hartmann’s procedure vs abdominoperineal resection with intersphincteric dissection in patients with rectal cancer: a randomized multicentre trial (HAPIrect)

BMC Surgery

Study Protocol

Maziar Nikberg¹  Abbas Chabok¹  Ingvar Sverrisson¹  Kenneth Smedh¹ 

[1] Colorectal Unit, Department of Surgery and Centre for Clinical Research, Uppsala University, Västmanland’s Hospital Västerås, 721 89, Västerås, Sweden;

关键词: Rectal Cancer;    Pelvic Floor;    Fecal Incontinence;    Total Mesorectal Excision;    Rectal Cancer Patient;   

DOI  :  10.1186/s12893-016-0161-2

 received in 2015-12-11, accepted in 2016-06-21,  发布年份 2016

来源: Springer

【 摘 要 】

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.

【 授权许可】

CC BY   
© The Author(s). 2016