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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 164
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Västerås, Sweden, 72189
    • Västmanlands Hospital Västerås

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Late complications after surgery	Perineal pain, secretion from the ano-rectal stump	One year postoperativelly

Collaborators and Investigators

• Sponsor: Region Västmanland
• Investigators: Principal Investigator: Kenneth Smedh, PhD, Region Västmanland

Publications and helpful links

General Publications

• Smedh 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (ACTUAL): December 1, 2021
• Study Completion (ACTUAL): December 1, 2021

Study Registration Dates

• First Submitted: November 21, 2013
• First Submitted That Met QC Criteria: November 21, 2013
• First Posted (ESTIMATE): November 26, 2013

Study Record Updates

• Last Update Posted (ACTUAL): December 16, 2021
• Last Update Submitted That Met QC Criteria: December 1, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: 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: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: LTV-398121