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

NCT01995396 | Terminated DMC

• 1 other identifier: LTV-398121
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Rates ot postoperative surgical complications within 30 days.

  Perineal and abdominal wound infection, pelvic abscess urinary catheter at discharge etc

  30 days

Secondary Outcomes (7)

• Peroperative data

  day of surgery

• The rate of intraoperative perforations

  day of surgery

• Resection margins

  2-4 weeks after surgery

• Rate of local recurrence

  3 and 5 years postoperatively

• Survival after 3 and 5 years follow-up

  3 and 5 years postoperativelly

Other Outcomes (2)

• quality of life between the two methods

  Preoperative and one year after surgery

• Late complications after surgery

  One year postoperativelly

Study Arms (2)

APE with intersphincteric dissection

ACTIVE COMPARATOR

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

Procedure: Hartmann´s procedure

Hartmann´s procedure

ACTIVE COMPARATOR

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

Procedure: APE with intersphincteric dissection

Interventions

APE with intersphincteric dissection 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.

Hartmann´s procedure

Hartmann´s procedure PROCEDURE

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

APE with intersphincteric dissection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Västmanland: lead

Study Sites (1)

Västmanlands Hospital Västerås

Västerås, 72189, Sweden

Location

Related Publications (2)

• 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.

  PMID: 41026509 DERIVED

• 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.

  PMID: 27401339 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms; Fecal Incontinence; Postoperative Complications

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kenneth Smedh, PhD

  Region Vastmanland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 21, 2013
• First Posted: November 26, 2013
• Study Start: February 1, 2014
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: December 16, 2021

Record last verified: 2021-12

Locations

SE (1)