Rectal CancerHAPIrectNCT01995396
Hartmanns Procedure or Abdominoperineal Excision With Intersphincteric Dissection in Rectal Cancer: a Randomized Study
A study testing APE with intersphincteric dissection and Hartmann´s procedure in people with Rectal Cancer and Sphincter Ani Incontinence, run by Region Västmanland at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer, Sphincter Ani Incontinence, Other Diagnoses, Comorbidities, and Complications
- What is being tested?
- APE with intersphincteric dissection and Hartmann´s procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2014to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- APE with intersphincteric dissection, Hartmann´s procedure
- Keywords
- rectal cancer,, fecal incontinence,, severe co-morbidity,, Hartmann´s procedure,, abdominoperineal excision with intersphincteric dissection,, postoperative complications,, pelvic abscess,, perineal infections
- Medical subject headings
- Rectal Neoplasms, Fecal Incontinence, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APE with intersphincteric dissectionProcedure or surgery
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 procedureProcedure or surgery
Abdominal operation where the rectum is resected and stapled off distally and a stoma is created
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: APE with intersphincteric dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates ot postoperative surgical complications within 30 days.
Perineal and abdominal wound infection, pelvic abscess urinary catheter at discharge etc
Measured: 30 days
Secondary outcomes (7)
Peroperative data
time of surgery, bleeding in ml, peroperative complications, type of staplers used
Measured: day of surgery
The rate of intraoperative perforations
record perforation of rectum or tumour during surgery
Measured: day of surgery
Resection margins
Histopathological report
Measured: 2-4 weeks after surgery
Rate of local recurrence
Record local recurrence during follow-up. CT-scan after 1 and 3 years
Measured: 3 and 5 years postoperatively
Survival after 3 and 5 years follow-up
overall survival
Measured: 3 and 5 years postoperativelly
Postoperative actions
reoperation, interventions(percutaneous drains etc) hospital stay, rehospitalisation
Measured: within 30 days
Other postop complications
other infectious, cardio-pulmonary and thromb-embolic complications.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2013 (estimated)
- Study startFeb 2014
- Primary completionDec 2021
- Study completionDec 2021
Why it stopped: Decision after interims analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Västmanland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth Smedh, Region Västmanland
- Investigators
- Kenneth Smedh, PhD, Principal investigator, Region Vastmanland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01995396
- Sponsor's protocol ID
- LTV-398121
- Acronym
- HAPIrect
- Status last verified
- Dec 2021
- First submitted
- 21 Nov 2013
- Last updated
- 16 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 41026509Smedh 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.
PubMed 27401339
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hartmanns Procedure or Abdominoperineal Excision With Intersphincteric Dissection in Rectal Cancer: a Randomized Study
- ClinicalTrials.gov ID
- NCT01995396
- Acronym / sponsor ID
- HAPIrect / LTV-398121
- 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 type
- Interventional
- Recruitment status
- TerminatedReason stopped: Decision after interims analysis
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Region VästmanlandUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Dec 2021 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 26 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APE with intersphincteric dissection | Active comparator | Procedure: Hartmann´s procedureAbdominoperineal excision with intersphincteric dissection and a stoma is performed in patients with rectal cancer and fecal incontinence and/or severe co-morbidity |
| Hartmann´s procedure | Active comparator | Procedure: APE with intersphincteric dissectionHartmann´s operation and stoma is performed in patients with rectal cancer and fecal incontinence and/or severe co-morbidity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APE with intersphincteric dissectionAbdominal 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. | Procedure or surgery | Hartmann´s procedure |
| Hartmann´s procedureAbdominal operation where the rectum is resected and stapled off distally and a stoma is created | Procedure or surgery | APE with intersphincteric dissection |
Primary outcome
Rates ot postoperative surgical complications within 30 days.
Time frame: 30 days
Perineal and abdominal wound infection, pelvic abscess urinary catheter at discharge etc
7 secondary outcomes
Peroperative data
Time frame: day of surgery
The rate of intraoperative perforations
Time frame: day of surgery
Resection margins
Time frame: 2-4 weeks after surgery
Rate of local recurrence
Time frame: 3 and 5 years postoperatively
Survival after 3 and 5 years follow-up
Time frame: 3 and 5 years postoperativelly
Postoperative actions
Time frame: within 30 days
Other postop complications
Time frame: 30 days
Results and safety
The study was stopped early (reason given: Decision after interims analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2021.
- Derived from this study: PubMed 41026509Nikberg 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.
- Derived from this study: PubMed 27401339Smedh 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth Smedh, PhD principal investigator
Region Vastmanland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing APE with intersphincteric dissection and Hartmann´s procedure in people with Rectal Cancer and Sphincter Ani Incontinence, run by Region Västmanland at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Decision after interims analysis). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates ot postoperative surgical complications within 30 days. (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01995396, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2021.