NCT01609504

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
283

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Apr 1997

Longer than P75 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1997

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2004

Completed
7.5 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2011

Completed
9 months until next milestone

First Posted

Study publicly available on registry

June 1, 2012

Completed
Last Updated

June 1, 2012

Status Verified

May 1, 2012

Enrollment Period

7 years

First QC Date

September 15, 2011

Last Update Submit

May 29, 2012

Conditions

Rectal Cancer

Keywords

Rectal cancerRadiochemotherapyTransanal Endoscopic MicrosurgeryLaparoscopic Resection

Outcome Measures

Primary Outcomes (1)

  • oncological result in term of local and/or systematic recurrence

    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.

    3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 42, 48, 54, 60 months after operation

Secondary Outcomes (7)

  • Morbidity

    participants will be followed for the duration of hospital stay, an expected average of 3 and 6 days each group

  • operative time

    operative time

  • blood loss

    during time of operation

  • analgesic use

    participants will be followed for the duration of hospital stay, an expected average of 3 and 6 days each group

  • 30 day mortality

    at 30 days from operation

  • +2 more secondary outcomes

Study Arms (2)

Transanal Endoscopic Microsurgery

EXPERIMENTAL

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

Total Mesorectal Excision

ACTIVE COMPARATOR
Procedure: LTME

Interventions

ELRR BY TEMPROCEDURE

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

Also known as: FULL-THICKNESS + FAT EXCISION BY TEM
Transanal Endoscopic Microsurgery
LTMEPROCEDURE

LAPAROSCOPIC TOTAL MESORECTAL EXCISION INCLUDING MESORECTAL (ACCORDING TO HEALD CRITERIA)

Also known as: LAPAROSCOPIC LOW ANTERIOR/ABDOMINO-PERINEAL RESECTION
Total Mesorectal Excision

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients classified as American Society of Anaesthesiologists (ASA) 3 or 4

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Motamedi MAK, Mak NT, Brown CJ, Raval MJ, Karimuddin AA, Giustini D, Phang PT. Local versus radical surgery for early rectal cancer with or without neoadjuvant or adjuvant therapy. Cochrane Database Syst Rev. 2023 Jun 13;6(6):CD002198. doi: 10.1002/14651858.CD002198.pub3.

    PMID: 37310167DERIVED

  • Lezoche E, Baldarelli M, Lezoche G, Paganini AM, Gesuita R, Guerrieri M. Randomized clinical trial of endoluminal locoregional resection versus laparoscopic total mesorectal excision for T2 rectal cancer after neoadjuvant therapy. Br J Surg. 2012 Sep;99(9):1211-8. doi: 10.1002/bjs.8821.

    PMID: 22864880DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Proctectomy

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, ColorectalDigestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Emanuele Lezoche, Pr

    university Sapienza of Rome, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 15, 2011

First Posted

June 1, 2012

Study Start

April 1, 1997

Primary Completion

April 1, 2004

Study Completion

April 1, 2004

Last Updated

June 1, 2012

Record last verified: 2012-05