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Hartmanns Procedure or Abdominoperineal Excision With Intersphincteric Dissection in Rectal Cancer: a Randomized Study

Hartmanns Procedure or Abdominoperineal Excision With Intersphincteric Dissection in Rectal Cancer: a Randomized Study

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01995396
Acronym
HAPIrect
Enrollment
164
Registered
2013-11-26
Start date
2014-02-28
Completion date
2021-12-31
Last updated
2021-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Other Diagnoses, Comorbidities, and Complications, Rectal Cancer, Sphincter Ani Incontinence

Keywords

rectal cancer,, fecal incontinence,, severe co-morbidity,, Hartmann´s procedure,, abdominoperineal excision with intersphincteric dissection,, postoperative complications,, pelvic abscess,, perineal infections

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.

Interventions

PROCEDUREAPE with intersphincteric dissection

Abdominal operation where the rectum is resected down to the levator and then the anus is resected by an intersphincteric dissection and order to leave the outer sfincter and levator in place to avoid a large wound and a high rate of infectious complications.

PROCEDUREHartmann´s procedure

Abdominal operation where the rectum is resected and stapled off distally and a stoma is created

Sponsors

Region Västmanland
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Rates ot postoperative surgical complications within 30 days.30 daysPerineal and abdominal wound infection, pelvic abscess urinary catheter at discharge etc

Secondary

MeasureTime frameDescription
Peroperative dataday of surgerytime of surgery, bleeding in ml, peroperative complications, type of staplers used
The rate of intraoperative perforationsday of surgeryrecord perforation of rectum or tumour during surgery
Resection margins2-4 weeks after surgeryHistopathological report
Rate of local recurrence3 and 5 years postoperativelyRecord local recurrence during follow-up. CT-scan after 1 and 3 years
Postoperative actionswithin 30 daysreoperation, interventions(percutaneous drains etc) hospital stay, rehospitalisation
Other postop complications30 daysother infectious, cardio-pulmonary and thromb-embolic complications.
Survival after 3 and 5 years follow-up3 and 5 years postoperativellyoverall survival

Other

MeasureTime frameDescription
quality of life between the two methodsPreoperative and one year after surgeryQoL protocol according to the QoLiRECT-study (Quality of life rectal cancer study) a study running from Gothenburg, Sweden
Late complications after surgeryOne year postoperativellyPerineal pain, secretion from the ano-rectal stump

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026