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

NCT ID: NCT01995396

Last Updated: 2021-12-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 164 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2021-12-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

APE with intersphincteric dissection

Abdominoperineal excision with intersphincteric dissection and a stoma is performed in patients with rectal cancer and fecal incontinence and/or severe co-morbidity

Group Type: ACTIVE_COMPARATOR

Hartmann´s procedure

Intervention Type: PROCEDURE

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

Hartmann´s procedure

Hartmann´s operation and stoma is performed in patients with rectal cancer and fecal incontinence and/or severe co-morbidity

Group Type: ACTIVE_COMPARATOR

APE with intersphincteric dissection

Intervention Type: PROCEDURE

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.

Interventions

APE 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.

Intervention Type: PROCEDURE

Hartmann´s procedure

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Västmanland

OTHER

Sponsor Role: lead

Responsible Party

Kenneth Smedh

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kenneth Smedh, PhD

Role: PRINCIPAL_INVESTIGATOR

Region Vastmanland

Locations

Västmanlands Hospital Västerås

Västerås, , Sweden

Countries

Sweden

References

Nikberg M, Akerlund V, Swartling T, Buchwald P, Smedh K; HAPIrect Collaborative Study Group. Postoperative complications in Hartmann's procedure versus intersphincteric abdominoperineal excision in rectal cancer: randomized clinical trial (HAPIrect). BJS Open. 2025 Sep 8;9(5):zraf093. doi: 10.1093/bjsopen/zraf093.

Reference Type: DERIVED

PMID: 41026509 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27401339 (View on PubMed)

Other Identifiers

LTV-398121

Identifier Type: -

Identifier Source: org_study_id