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

NCT04401787 | Completed DMC

• 1 other identifier: IR-20780302-1
• Study Type: interventional
• Target: 156
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cancer, Rectum

Keywords

rectal cancer; laparoscopic resection; obesity

Outcome Measures

Primary Outcomes (4)

• recovery time-intraoperative bleeding

  up to 3 years

• Incidence of wound infection

  up to 3 years

• hospital stay-perioperative length

  up to 3 years

• oncological outcome

  total mesorectal excision, margin included or not

  3 years

Secondary Outcomes (1)

• early locoregional recurrence

  6 months

Study Arms (2)

laparoscopic anterior resection (LAR)

ACTIVE COMPARATOR

LAR group included 88 patients, 17 patients converted to open

Procedure: Anterior resection for upper rectal cancer in obese

open anterior resection

ACTIVE COMPARATOR

Open anterior resection for 56 patients

Procedure: Anterior resection for upper rectal cancer in obese

Interventions

Anterior resection for upper rectal cancer in obese PROCEDURE

Anterior resection for upper rectal cancer in obese

laparoscopic anterior resection (LAR); open anterior resection

Eligibility Criteria

• Age: 26 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zagazig University: lead

Related Publications (2)

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

  PMID: 29025162 RESULT

• 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.

  PMID: 29610930 RESULT

Related Links

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

MeSH Terms

Conditions

Rectal Neoplasms; Obesity

Interventions

Adiposity

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Body Fat Distribution; Body Weights and Measures; Body Constitution; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Body Composition; Biochemical Phenomena; Chemical Phenomena; Metabolism; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of general surgery

Model Details: 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.

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: May 26, 2020
• Study Start: December 11, 2016
• Primary Completion: December 29, 2019
• Study Completion: May 18, 2020
• Last Updated: May 26, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 1 year
• Access Criteria: laparoscopic anterior resection for upper rectal cancer in obese patients