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Converted Laparoscopic Resection of Upper Rectal Carcinoma T1-4 N0-1 in Obese Patients.

Primary Purpose

Cancer, Rectum

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Anterior resection for upper rectal cancer in obese
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer, Rectum focused on measuring rectal cancer, laparoscopic resection, obesity

Eligibility Criteria

26 Years - 74 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Obese patients with BMI ≥27 with operable upper rectal carcinoma staged T1-4 N0-1 based on colonoscopy, endo-rectal ultrasound, CT abdomen and pelvis and MRI abdomen

Exclusion Criteria:

  • BMI less than 27, According to AJCC TNM staging 7th edition, N2-3 patients were excluded, any evidence of inoperability whether distant metastasis or invasive tumours, Patients with synchronous colorectal tumours, synchronous liver metastasis obstructive symptomatic patients and patients with intraoperative tumour rupture or perforation, rectal tumours below peritoneal reflection

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    laparoscopic anterior resection (LAR)

    open anterior resection

    Arm Description

    LAR group included 88 patients, 17 patients converted to open

    Open anterior resection for 56 patients

    Outcomes

    Primary Outcome Measures

    recovery time-intraoperative bleeding
    Incidence of wound infection
    hospital stay-perioperative length
    oncological outcome
    total mesorectal excision, margin included or not

    Secondary Outcome Measures

    early locoregional recurrence
    early locoregional recurrence within 6 months

    Full Information

    First Posted
    May 19, 2020
    Last Updated
    May 22, 2020
    Sponsor
    Zagazig University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04401787
    Brief Title
    Converted Laparoscopic Resection of Upper Rectal Carcinoma T1-4 N0-1 in Obese Patients.
    Official Title
    Is There Better Oncological and Short Term Outcome for Laparoscopic Resection of Upper Rectal Carcinoma T1-4 N0-1 Over Laparoscopic Converted Cases in Obese Patients?
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    December 11, 2016 (Actual)
    Primary Completion Date
    December 29, 2019 (Actual)
    Study Completion Date
    May 18, 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Zagazig University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Background: laparoscopic resection (LAR) is a safe approach and widely used for rectal cancer after neoadjuvant chemo-radiotherapy, but short term and oncological outcome for converted cases to open surgery (cLAR), may be questioned in an obese patient. Objective: validating the short-term and oncological outcomes after laparoscopic resection and after conversion to open surgery for upper rectal cancer in obese patients. Patients and methods: A prospective study included 191 patients, randomly allocated into two arms of the study, Arm I is open anterior resection (OAR), this is the control and arm II, The LAR. Only 156 analyzed.
    Detailed Description
    Study design: A randomized control study assigned to involve obese patients with BMI 30 diagnosed with upper rectal carcinoma T1-4 N0-1, 181 patients assigned into two arms and operated in multi-centres in a tertiary hospitals. Ethical approval and clinical registration: Our study was submitted, revised and finally permitted and approved by the Institutional Review Board of the Zagazig University hospital, faculty of medicine, holding number IR-20780302-1, and informed consent was obtained from all participants agreed to be involved. Study registered in ClinicalTrial.gove: ID: ……… Protocol and setting: A study was done in the period from December 2016 to December 2019 and data registered after each procedure in our database system The controlled arm included patients underwent open anterior resection (OAR) for upper rectal carcinoma and divided into Ia, underwent OAR and IIa, included patients with cLAR, whereas Group II included patients underwent LAR. Method of randomization: Randomization was done via a computer-generated protocol, already designed and uploaded in our database, and the results were unlabeled and sealed into envelopes. These envelopes were opened in the operating room by the head-nurse and an assistant surgery specialist who was not engaged in the study Inclusion criteria: Obese patients with BMI ≥27 with operable upper rectal carcinoma staged T1-4 N0-1 based on colonoscopy, endo-rectal ultrasound, CT abdomen and pelvis and MRI abdomen Exclusion criteria BMI less than 27, According to AJCC TNM staging 7th edition, N2-3 patients were excluded, any evidence of inoperability whether distant metastasis or invasive tumours, Patients with synchronous colorectal tumours, synchronous liver metastasis obstructive symptomatic patients and patients with intraoperative tumour rupture or perforation, rectal tumours below peritoneal reflection. There are 2 parameters prospectively assessed and registered in our database: First the clinical parameters, second is the onco-pathological parameter Clinical parameter included, operative basic demographic data (age, sex and BMI), peri-operative clinical variables ( operative time, intraoperative complication, completeness of TME, the feasibility of stapling, causes of conversion if there, postoperative (PO) short term outcome, Recovery, hospital stay, PO morbidity and bowel function. The onco-pathological outcome included: tumour site, site and staging of tumour according to TNM- longitudinal and circumferential resection margin- LN involved (N) - loco-regional recurrence and recurrence-free survival. Intervention methods The preoperative nCRT: our protocol according to a multidisciplinary tumour board committee, is to give a long course of neo-adjuvant chemo-radiotherapy for mid and lower rectal cancer but upper rectum, we give a 4 weeks course of CRT, 45 Gy with systemic 5-fluorouracil based regimen infusion. This is proposed for stage II-III not stage I.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cancer, Rectum
    Keywords
    rectal cancer, laparoscopic resection, obesity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    A prospective study included 191 patients, randomly allocated into two arms of the study, Arm I is open anterior resection (OAR), this is the control and arm II, The LAR. Only 156 analyzed.
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    156 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    laparoscopic anterior resection (LAR)
    Arm Type
    Active Comparator
    Arm Description
    LAR group included 88 patients, 17 patients converted to open
    Arm Title
    open anterior resection
    Arm Type
    Active Comparator
    Arm Description
    Open anterior resection for 56 patients
    Intervention Type
    Procedure
    Intervention Name(s)
    Anterior resection for upper rectal cancer in obese
    Intervention Description
    Anterior resection for upper rectal cancer in obese
    Primary Outcome Measure Information:
    Title
    recovery time-intraoperative bleeding
    Time Frame
    up to 3 years
    Title
    Incidence of wound infection
    Time Frame
    up to 3 years
    Title
    hospital stay-perioperative length
    Time Frame
    up to 3 years
    Title
    oncological outcome
    Description
    total mesorectal excision, margin included or not
    Time Frame
    3 years
    Secondary Outcome Measure Information:
    Title
    early locoregional recurrence
    Description
    early locoregional recurrence within 6 months
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    26 Years
    Maximum Age & Unit of Time
    74 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Obese patients with BMI ≥27 with operable upper rectal carcinoma staged T1-4 N0-1 based on colonoscopy, endo-rectal ultrasound, CT abdomen and pelvis and MRI abdomen Exclusion Criteria: BMI less than 27, According to AJCC TNM staging 7th edition, N2-3 patients were excluded, any evidence of inoperability whether distant metastasis or invasive tumours, Patients with synchronous colorectal tumours, synchronous liver metastasis obstructive symptomatic patients and patients with intraoperative tumour rupture or perforation, rectal tumours below peritoneal reflection

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    through international publication
    IPD Sharing Time Frame
    1 year
    IPD Sharing Access Criteria
    laparoscopic anterior resection for upper rectal cancer in obese patients
    Citations:
    PubMed Identifier
    29025162
    Citation
    Kinlen D, Cody D, O'Shea D. Complications of obesity. QJM. 2018 Jul 1;111(7):437-443. doi: 10.1093/qjmed/hcx152.
    Results Reference
    result
    PubMed Identifier
    29610930
    Citation
    Allaix ME, Furnee E, Esposito L, Mistrangelo M, Rebecchi F, Arezzo A, Morino M. Analysis of Early and Long-Term Oncologic Outcomes After Converted Laparoscopic Resection Compared to Primary Open Surgery for Rectal Cancer. World J Surg. 2018 Oct;42(10):3405-3414. doi: 10.1007/s00268-018-4614-x.
    Results Reference
    result
    Links:
    URL
    https://link.springer.com/article/10.1007/s12262-020-02299-4
    Description
    Total Laparoscopic Approach for Rectal Cancer Resection-a Novel Technique and Review of the Literature

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    Converted Laparoscopic Resection of Upper Rectal Carcinoma T1-4 N0-1 in Obese Patients.

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