Converted Laparoscopic Resection of Upper Rectal Carcinoma T1-4 N0-1 in Obese Patients.
Condition: Cancer, Rectum
MeSH terms: Rectal Neoplasms
Study type: Interventional

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.
    

Intervention name(s): Anterior resection for upper rectal cancer in obese
Intervention type(s): Procedure
Intervention description(s): Anterior resection for upper rectal cancer in obese
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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: Single (Participant)
Primary purpose: Treatment
Keywords: rectal cancer; laparoscopic resection; obesity