Clinical trial · Interventional
Hartmanns Procedure or Abdominoperineal Excision With Intersphincteric Dissection in Rectal Cancer: a Randomized Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Decision after interims analysis
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Other Diagnoses, Comorbidities, and Complications | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
| Sphincter Ani Incontinence | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| APE with intersphincteric dissection | Procedure | — | UNRESOLVED |
| Hartmann´s procedure | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- APE with intersphincteric dissection
- description
- Abdominoperineal excision with intersphincteric dissection and a stoma is performed in patients with rectal cancer and fecal incontinence and/or severe co-morbidity
- interventionNames
- Procedure: Hartmann´s procedure
- type
- ACTIVE_COMPARATOR
- label
- Hartmann´s procedure
- description
- Hartmann´s operation and stoma is performed in patients with rectal cancer and fecal incontinence and/or severe co-morbidity
- interventionNames
- Procedure: APE with intersphincteric dissection
Primary outcomes (1)
- measure
- Rates ot postoperative surgical complications within 30 days.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDNikberg 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
- DERIVEDSmedh 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