Clinical trial NCT01995396: Hartmanns Procedure or Abdominoperineal Excision With Intersphincteric Dissection in Rectal Cancer: a Randomized Study
Official title: Hartmanns Procedure or Abdominoperineal Excision With Intersphincteric Dissection in Rectal Cancer: a Randomized Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Rectal Cancer
Sphincter Ani Incontinence
Other Diagnoses, Comorbidities, and Complications
Keywords: rectal cancer,
fecal incontinence,
severe co-morbidity,
Hartmann´s procedure,
abdominoperineal excision with intersphincteric dissection,
postoperative complications,
pelvic abscess,
perineal infections
Lead sponsor: Region Västmanland
Sponsor class: OTHER
First posted: 2013-11-26
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In patients with rectal cancer, an anterior resection with a colo-rectal or colo-anal anastomoses is the gold standard. However, in patients with a weak sphincter and fecal incontinence or in patients with severe co-morbidity and reduced general condition, this operation is not suitable.

In these situations there are two other radical surgical options, Hartmanns procedure and the Abdominoperineal excision that can be performed with intersphincteric dissection to minimise perineal complications.There are no data on which of these procedures that are best suited for these patients with fecal incontinence or severe co-morbidity( at risk for life-threatening anastomotic leak). In this randomized study we intend to compare postoperative complications within 30 days after these two procedures and also late complications and quality of life after one year postoperatively.

Detailed description: In patients with rectal cancer, an abdominal operation with anterior resection with total mesorectal excision is the gold standard. Colon is anastomosed to the ano-rectum.The potential risks are bad bowel function with fecal incontinence or a lifethreatening anastomotic dehiscence, especially in patients with severe co-morbidity or reduced general condition.Tumours in the low rectum are usually treated with an abdominoperineal resection where the whole anus is radically excised and a permanent colostomy is created.

For patients with incontinence and/or severe comorbidity, Hartmann´s procedure has often been performed. The rectum is resected, the lower part is transected with a stapler and a colostomy is created. During recent years there has been reports on high rates of pelvic abscesses after Hartmann´s. An alternative has been proposed, namely the abdominoperineal excision (APE) with intersphincteric dissection leaving the outer sphincter and levator muscles in place, thus creating a much lesser perineal wound that also tend to heal better when the ano-pelvic muscles are left in place.

There have been some small retrospective studies comparing postoperative complications after Hartmann´s with anterior resections or the classic abdominoperineal excision. These studies are heterogenous and not balanced and no conclusions can be drawn. There are no data on APE with intersphincteric dissection in rectal cancer patients.

There is a need to clarify what procedure is most suited for patients with rectal cancer and fecal incontinence and / or severe comorbidity.

For this patient group we intend to randomize between Hartmann´s procedure and APE with intersphincteric dissection.

Eligibility criteria: Inclusion Criteria:

* Rectal cancer 5cm or more from the anal verge
* Both procedures should be possible to perform
* Patients should have co-morbidities and/or have weak anal sphincter where an anterior resection is not suitable
* Metastases are no contraindication but the procedure should be assessed as locally radical.
* Patients should be assesed to cope with a major abdominal procedure(ASA I-III)

Exclusion Criteria:

* rectal cancer below 5cm from the anal verge where a Hartmann is considered not to be locally radical.
* patients where an anterior resection is suitable
* ASA IV or worse

Primary outcomes:
measure: Rates ot postoperative surgical complications within 30 days.
timeFrame: 30 days
Secondary outcomes:
measure: Peroperative data
timeFrame: day of surgery
measure: The rate of intraoperative perforations
timeFrame: day of surgery
measure: Resection margins
timeFrame: 2-4 weeks after surgery
measure: Rate of local recurrence
timeFrame: 3 and 5 years postoperatively
measure: Survival after 3 and 5 years follow-up
timeFrame: 3 and 5 years postoperativelly
measure: Postoperative actions
timeFrame: within 30 days
measure: Other postop complications
timeFrame: 30 days
Other outcomes:
measure: quality of life between the two methods
timeFrame: Preoperative and one year after surgery
measure: Late complications after surgery
timeFrame: One year postoperativelly
Locations:
city: Västerås
country: Sweden
facility: Västmanlands Hospital Västerås
Study officials:
affiliation: Region Vastmanland
name: Kenneth Smedh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Smedh K, Sverrisson I, Chabok A, Nikberg M; HAPIrect Collaborative Study Group. Hartmann's procedure vs abdominoperineal resection with intersphincteric dissection in patients with rectal cancer: a randomized multicentre trial (HAPIrect). BMC Surg. 2016 Jul 11;16(1):43. doi: 10.1186/s12893-016-0161-2.