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ELRR by TEM Versus Laparoscopic TME in iT2N0M0 SMALL LOW RECTAL CANCER (ELRRvsLTME)

This study has been completed.
Sponsor:
Collaborator:
Università Politecnica delle Marche
Information provided by (Responsible Party):
Lezoche Emanuele, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT01609504
First received: September 15, 2011
Last updated: May 29, 2012
Last verified: May 2012
  Purpose

The present prospective randomized study investigated the results of ELRR (ENDOLUMINAL LOCO-REGIONAL RESECTION BY TRANSANAL ENDOSCOPIC MICROSURGERY) versus LTME (LAPAROSCOPIC TOTAL MESORECTAL EXCISION) in the management of 100 patients with iT2N0M0 small low rectal cancer after Neoadjuvant Treatment.


Condition Intervention Phase
Rectal Cancer
Procedure: ELRR BY TEM
Procedure: LTME
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Controlled Clinical Trial: Endoluminal Loco-regional Resection (ELRR) by Transanal Endoscopic Microsurgery (TEM) Versus Laparoscopic Total Mesorectal Excision (LTME) in it2n0m0 Small Low Rectal Cancer

Resource links provided by NLM:


Further study details as provided by University of Roma La Sapienza:

Primary Outcome Measures:
  • oncological result in term of local and/or systematic recurrence [ Time Frame: 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 42, 48, 54, 60 months after operation ] [ Designated as safety issue: Yes ]
    To evaluate local and/or systematic recurrence, all patients were followed up prospectively by clinical examination, measurement of tumour markers and sigmoidoscopy every 3 months for the first 3 years, and every 6 months thereafter. Whole-body CT and pelvic MRI were repeated every 6 months for the first 5 year. All patients had a minimum follow-up of 5 years.


Secondary Outcome Measures:
  • Morbidity [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 and 6 days each group ] [ Designated as safety issue: No ]
    No. of patients with postoperative complications

  • operative time [ Time Frame: operative time ] [ Designated as safety issue: No ]
    operative time (minutes)

  • blood loss [ Time Frame: during time of operation ] [ Designated as safety issue: No ]
    blood loss (ml)

  • analgesic use [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 and 6 days each group ] [ Designated as safety issue: No ]
    No. of patients receiving analgesia

  • 30 day mortality [ Time Frame: at 30 days from operation ] [ Designated as safety issue: Yes ]
    No. of patients died within 30 days from operation

  • hospital stay [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 and 6 days each group ] [ Designated as safety issue: No ]
    hospital stay (days)

  • cancer-related mortality [ Time Frame: 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 42, 48, 54, 60 months after operation ] [ Designated as safety issue: Yes ]
    No. of patients died for cancer. To evaluate local and/or systemic recurrence, all patients were followed up prospectively. After 5 year every 12 months. All patients had a minimum follow-up of 5 years


Enrollment: 283
Study Start Date: April 1997
Study Completion Date: April 2004
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Transanal Endoscopic Microsurgery
Patients were treated by TEM as follows: mucosal incision included all the tatoo spots performed at admission staging, in order to excise a minimum of 1 cm of normal mucosa around the tumor, according to its diameter before NT (ELRR- Endo Luminal Loco Regional Resection)
Procedure: ELRR BY TEM
The surgical technique of ELRR was as follows: mucosal incision included all the tatoo spots performed at admission staging, in order to excise a minimum of 1 cm of normal mucosa around the tumor, according to its diameter before NT
Other Name: FULL-THICKNESS + FAT EXCISION BY TEM
Active Comparator: Total Mesorectal Excision Procedure: LTME
LAPAROSCOPIC TOTAL MESORECTAL EXCISION INCLUDING MESORECTAL (ACCORDING TO HEALD CRITERIA)
Other Name: LAPAROSCOPIC LOW ANTERIOR/ABDOMINO-PERINEAL RESECTION

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  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Tumor located within 6 cm from the anal verge
  • Tumor diameter not larger than 3 cm, and staged as iT2, N0, G1-2

Exclusion Criteria:

  • Patients classified as American Society of Anaesthesiologists (ASA) 3 or 4
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01609504

Sponsors and Collaborators
University of Roma La Sapienza
Università Politecnica delle Marche
Investigators
Principal Investigator: Emanuele Lezoche, Pr university Sapienza of Rome, Italy
  More Information

No publications provided by University of Roma La Sapienza

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lezoche Emanuele, Professor, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT01609504     History of Changes
Other Study ID Numbers: URBINO-LEZ-1995
Study First Received: September 15, 2011
Last Updated: May 29, 2012
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by University of Roma La Sapienza:
Rectal cancer
Radiochemotherapy
Transanal Endoscopic Microsurgery
Laparoscopic Resection

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on November 20, 2014