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

December 1, 2021 updated by: Kenneth Smedh, Region Västmanland

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
164

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rates ot postoperative surgical complications within 30 days.
Time Frame: 30 days
Perineal and abdominal wound infection, pelvic abscess urinary catheter at discharge etc
30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Peroperative data
Time Frame: day of surgery
time of surgery, bleeding in ml, peroperative complications, type of staplers used
day of surgery
The rate of intraoperative perforations
Time Frame: day of surgery
record perforation of rectum or tumour during surgery
day of surgery
Resection margins
Time Frame: 2-4 weeks after surgery
Histopathological report
2-4 weeks after surgery
Rate of local recurrence
Time Frame: 3 and 5 years postoperatively
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
Time Frame: 3 and 5 years postoperativelly
overall survival
3 and 5 years postoperativelly
Postoperative actions
Time Frame: within 30 days
reoperation, interventions(percutaneous drains etc) hospital stay, rehospitalisation
within 30 days
Other postop complications
Time Frame: 30 days
other infectious, cardio-pulmonary and thromb-embolic complications.
30 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Preoperative and one year after surgery
Late complications after surgery
Time Frame: One year postoperativelly
Perineal pain, secretion from the ano-rectal stump
One year postoperativelly

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Region Västmanland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kenneth Smedh, PhD, Region Västmanland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 21, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 26, 2013

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 16, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LTV-398121

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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