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

Rectal Cancer Clinical Trial

— HAPIrect  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01995396
• Other study ID #: LTV-398121
• Status: Terminated
• Phase: N/A
• Start date: February 2014
• Est. completion date: December 2021

Study information

• Verified date: December 2021
• Source: Region Västmanland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 164
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Other Diagnoses, Comorbidities, and Complications
• Rectal Cancer
• Rectal Neoplasms
• Sphincter Ani Incontinence

Intervention

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.
• Hartmann´s procedure
Abdominal operation where the rectum is resected and stapled off distally and a stoma is created

Locations

Country	Name	City	State
Sweden	Västmanlands Hospital Västerås	Västerås

Sponsors (1)

Lead Sponsor	Collaborator
Region Västmanland

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	quality of life between the two methods	QoL protocol according to the QoLiRECT-study (Quality of life rectal cancer study) a study running from Gothenburg, Sweden	Preoperative and one year after surgery
Other	Late complications after surgery	Perineal pain, secretion from the ano-rectal stump	One year postoperativelly
Primary	Rates ot postoperative surgical complications within 30 days.	Perineal and abdominal wound infection, pelvic abscess urinary catheter at discharge etc	30 days
Secondary	Peroperative data	time of surgery, bleeding in ml, peroperative complications, type of staplers used	day of surgery
Secondary	The rate of intraoperative perforations	record perforation of rectum or tumour during surgery	day of surgery
Secondary	Resection margins	Histopathological report	2-4 weeks after surgery
Secondary	Rate of local recurrence	Record local recurrence during follow-up. CT-scan after 1 and 3 years	3 and 5 years postoperatively
Secondary	Survival after 3 and 5 years follow-up	overall survival	3 and 5 years postoperativelly
Secondary	Postoperative actions	reoperation, interventions(percutaneous drains etc) hospital stay, rehospitalisation	within 30 days
Secondary	Other postop complications	other infectious, cardio-pulmonary and thromb-embolic complications.	30 days