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

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ClinicalTrials.gov Identifier: NCT01995396
Recruitment Status : Recruiting
First Posted : November 26, 2013
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
Kenneth Smedh, Region Västmanland

Study Description
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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.


Condition or disease Intervention/treatment Phase
Rectal Cancer Sphincter Ani Incontinence Other Diagnoses, Comorbidities, and Complications Procedure: APE with intersphincteric dissection Procedure: Hartmann´s procedure Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hartmanns Procedure or Abdominoperineal Excision With Intersphincteric Dissection in Rectal Cancer: a Randomized Study
Study Start Date : February 2014
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : February 2025
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 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
 Procedure: Hartmann´s procedure
Abdominal operation where the rectum is resected and stapled off distally and a stoma is created
Active Comparator: Hartmann´s procedure
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
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.


Outcome Measures
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Primary Outcome Measures :
  1. Rates ot postoperative surgical complications within 30 days. [ Time Frame: 30 days ]
    Perineal and abdominal wound infection, pelvic abscess urinary catheter at discharge etc


Secondary Outcome Measures :
  1. Peroperative data [ Time Frame: day of surgery ]
    time of surgery, bleeding in ml, peroperative complications, type of staplers used

  2. The rate of intraoperative perforations [ Time Frame: day of surgery ]
    record perforation of rectum or tumour during surgery

  3. Resection margins [ Time Frame: 2-4 weeks after surgery ]
    Histopathological report

  4. Rate of local recurrence [ Time Frame: 3 and 5 years postoperatively ]
    Record local recurrence during follow-up. CT-scan after 1 and 3 years

  5. Survival after 3 and 5 years follow-up [ Time Frame: 3 and 5 years postoperativelly ]
    overall survival

  6. Postoperative actions [ Time Frame: within 30 days ]
    reoperation, interventions(percutaneous drains etc) hospital stay, rehospitalisation

  7. Other postop complications [ Time Frame: 30 days ]
    other infectious, cardio-pulmonary and thromb-embolic complications.


Other Outcome Measures:
  1. quality of life between the two methods [ Time Frame: Preoperative and one year after surgery ]
    QoL protocol according to the QoLiRECT-study (Quality of life rectal cancer study) a study running from Gothenburg, Sweden

  2. Late complications after surgery [ Time Frame: One year postoperativelly ]
    Perineal pain, secretion from the ano-rectal stump


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01995396


Contacts
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Contact: Kenneth Smedh, PhD +46-70-3735576 kenneth.smedh@regionvastmanland.se
Contact: Maziar Nikberg, PhD +4621173000 maziar.nikberg@regionvastmanland.se

Locations
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Sweden
Västmanlands Hospital Västerås Recruiting
Västerås, Sweden, 72189
Principal Investigator: Kenneth Smedh, PhD         
Sponsors and Collaborators
Region Västmanland
Investigators
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Principal Investigator: Kenneth Smedh, PhD Region Vastmanland
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Kenneth Smedh, Professor, Region Västmanland
ClinicalTrials.gov Identifier: NCT01995396    
Other Study ID Numbers: LTV-398121
First Posted: November 26, 2013    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Keywords provided by Kenneth Smedh, Region Västmanland:
rectal cancer,
fecal incontinence,
severe co-morbidity,
Hartmann´s procedure,
 abdominoperineal excision with intersphincteric dissection,
postoperative complications,
pelvic abscess,
perineal infections
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases