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

Not Applicable

Terminated

• Conditions: Rectal Cancer; Other Diagnoses, Comorbidities, and Complications; Sphincter Ani Incontinence
• Interventions: Procedure: APE with intersphincteric dissection; Procedure: Hartmann´s procedure

• Registration Number: NCT01995396
• Lead Sponsor: Region Västmanland

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.

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 Timeline

• Study First Submitted: 2013-11-21
• Study First Submitted QC: 2013-11-21
• Study First Posted: 2013-11-26
• Study Start: 2014-02
• Status Verified: 2021-12
• Primary Completion: 2021-12
• Study Completion: 2021-12
• Last Update Submitted: 2021-12-01
• Last Update Posted: 2021-12-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 164

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hartmann´s procedure	APE with intersphincteric dissection	Hartmann´s operation and stoma is performed in patients with rectal cancer and fecal incontinence and/or severe co-morbidity
APE with intersphincteric dissection	Hartmann´s procedure	Abdominoperineal excision with intersphincteric dissection and a stoma is performed in patients with rectal cancer and fecal incontinence and/or severe co-morbidity

Primary Outcome Measures

Name	Time	Method
Rates ot postoperative surgical complications within 30 days.	30 days	Perineal and abdominal wound infection, pelvic abscess urinary catheter at discharge etc

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Västmanlands Hospital Västerås; 🇸🇪 Västerås, Sweden