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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Rectal Cancer, Sphincter Ani Incontinence, Other Diagnoses, Comorbidities, and Complications

Intervention / Treatment
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* Procedure: APE with intersphincteric dissection
* Procedure: Hartmann´s procedure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: APE with intersphincteric dissection<br>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<br>* Abdominal operation where the rectum is resected and stapled off distally and a stoma is created<br>|
| Active Comparator: Hartmann´s procedure<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates ot postoperative surgical complications within 30 days. | Perineal and abdominal wound infection, pelvic abscess urinary catheter at discharge etc | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peroperative data | time of surgery, bleeding in ml, peroperative complications, type of staplers used | day of surgery | 
| The rate of intraoperative perforations | record perforation of rectum or tumour during surgery | day of surgery | 
| Resection margins | Histopathological report | 2-4 weeks after surgery | 
| Rate of local recurrence | Record local recurrence during follow-up. CT-scan after 1 and 3 years | 3 and 5 years postoperatively | 
| Survival after 3 and 5 years follow-up | overall survival | 3 and 5 years postoperativelly | 
| Postoperative actions | reoperation, interventions(percutaneous drains etc) hospital stay, rehospitalisation | within 30 days | 
| Other postop complications | other infectious, cardio-pulmonary and thromb-embolic complications. | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rectal cancer,, fecal incontinence,, severe co-morbidity,, Hartmann´s procedure,, abdominoperineal excision with intersphincteric dissection,, postoperative complications,, pelvic abscess,, perineal infections