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

NCT ID: NCT04401787

Last Updated: 2020-05-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-11
• Study Completion Date: 2020-05-18

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.

Conditions

Cancer, Rectum

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

laparoscopic anterior resection (LAR)

LAR group included 88 patients, 17 patients converted to open

Group Type: ACTIVE_COMPARATOR

Anterior resection for upper rectal cancer in obese

Intervention Type: PROCEDURE

Anterior resection for upper rectal cancer in obese

open anterior resection

Open anterior resection for 56 patients

Group Type: ACTIVE_COMPARATOR

Anterior resection for upper rectal cancer in obese

Intervention Type: PROCEDURE

Anterior resection for upper rectal cancer in obese

Interventions

Anterior resection for upper rectal cancer in obese

Anterior resection for upper rectal cancer in obese

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 26 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Bassem Mohamed Sieda

Assistant professor of general surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Kinlen D, Cody D, O'Shea D. Complications of obesity. QJM. 2018 Jul 1;111(7):437-443. doi: 10.1093/qjmed/hcx152.

Reference Type: RESULT

PMID: 29025162 (View on PubMed)

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.

Reference Type: RESULT

PMID: 29610930 (View on PubMed)

Related Links

https://link.springer.com/article/10.1007/s12262-020-02299-4

Total Laparoscopic Approach for Rectal Cancer Resection-a Novel Technique and Review of the Literature

Other Identifiers

IR-20780302-1

Identifier Type: -

Identifier Source: org_study_id