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

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ClinicalTrials.gov Identifier: NCT01995396
Recruitment Status : Recruiting
First Posted : November 26, 2013
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
Kenneth Smedh, Region Västmanland

Tracking Information
First Submitted Date  ICMJE November 21, 2013
First Posted Date  ICMJE November 26, 2013
Last Update Posted Date March 24, 2020
Study Start Date  ICMJE February 2014
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2020)
Rates ot postoperative surgical complications within 30 days. [ Time Frame: 30 days ]
Perineal and abdominal wound infection, pelvic abscess urinary catheter at discharge etc
Original Primary Outcome Measures  ICMJE
 (submitted: November 21, 2013)
Rates ot postoperative surgical complications within 30 days. [ Time Frame: 30 days ]
Perineal and abdominal wound infection, pelvic abscess, , urinary catheter at discharge etc
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2013)
  • Peroperative data [ Time Frame: day of surgery ]
    time of surgery, bleeding in ml, peroperative complications, type of staplers used
  • The rate of intraoperative perforations [ Time Frame: day of surgery ]
    record perforation of rectum or tumour during surgery
  • Resection margins [ Time Frame: 2-4 weeks after surgery ]
    Histopathological report
  • Rate of local recurrence [ Time Frame: 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 [ Time Frame: 3 and 5 years postoperativelly ]
    overall survival
  • Postoperative actions [ Time Frame: within 30 days ]
    reoperation, interventions(percutaneous drains etc) hospital stay, rehospitalisation
  • Other postop complications [ Time Frame: 30 days ]
    other infectious, cardio-pulmonary and thromb-embolic complications.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 22, 2020)
  • 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
  • Late complications after surgery [ Time Frame: One year postoperativelly ]
    Perineal pain, secretion from the ano-rectal stump
Original Other Pre-specified Outcome Measures
 (submitted: November 21, 2013)
  • quality of life [ 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
  • Late complications after surgery [ Time Frame: One year postoperativelly ]
    Perineal pain, secretion from the ano-rectal stump
 
Descriptive Information
Brief Title  ICMJE Hartmanns Procedure or Abdominoperineal Excision With Intersphincteric Dissection in Rectal Cancer: a Randomized Study
Official Title  ICMJE Hartmanns Procedure or Abdominoperineal Excision With Intersphincteric Dissection in Rectal Cancer: a Randomized Study
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Rectal Cancer
  • Sphincter Ani Incontinence
  • Other Diagnoses, Comorbidities, and Complications
Intervention  ICMJE
  • 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.
  • Procedure: Hartmann´s procedure
    Abdominal operation where the rectum is resected and stapled off distally and a stoma is created
Study Arms  ICMJE
  • 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
    Intervention: Procedure: Hartmann´s procedure
  • 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
    Intervention: Procedure: APE with intersphincteric dissection
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 21, 2013)
340
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2025
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kenneth Smedh, PhD +46-70-3735576 kenneth.smedh@regionvastmanland.se
Contact: Maziar Nikberg, PhD +4621173000 maziar.nikberg@regionvastmanland.se
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01995396
Other Study ID Numbers  ICMJE LTV-398121
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kenneth Smedh, Region Västmanland
Study Sponsor  ICMJE Region Västmanland
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kenneth Smedh, PhD Region Vastmanland
PRS Account Region Västmanland
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP