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