Anastomotic Leakage Following Laparoscopic Resection for Rectal Cancer

NCT02718729 | Completed DMC

• 1 other identifier: MD 84
• Study Type: interventional
• Target: 59
• Locations: 2 countries
• Sites: 2

Brief Summary

Anastomotic leak (AL) is a breakdown of a suture line in a surgical anastomosis with a subsequent leakage of the luminal content. Anastomotic leakage occurs commonly in rectal and esophageal anastomosis than the other parts of the alimentary tract due to technical difficulties in accessing these areas and their easily compromised blood supply. Anastomotic leakage is the most feared complication following rectal resection and anastomosis. The incidence of anastomotic leakage ranges from 2.8% to more than 15%, with mortality rate more than 30%. Subclinical anastomotic failure may occur in up to 51% of patients. Anastomotic leakage leads to increase the rate of secondary interventions, re-operations, longer postoperative hospital stay, increased cost, and major impact on the patient's quality of life. In the medium to long term, patient may be unfit for post-operative adjuvant therapy with decreased the disease survival. Furthermore anastomotic leakage itself may increase the local recurrence, a reduction in overall survival, and a large proportion of patients are left with a permanent stoma.

Conditions

Anastomotic Leakage

Keywords

Anastomotic leakage; Rectal cancer; Laparoscopic; Rectal resection

Outcome Measures

Primary Outcomes (1)

• Incidence of anastomotic leakage

  Incidence of anastomotic leakage in patients who underwent laparoscopic resection of rectal cancer. This including clinical and sub-clinical (radiological diagnosis) leakage.

  2 years

Secondary Outcomes (4)

• Role of diversion in prevention of anastomotic leakage.

  2 years

• Management of anastomotic leakage

  2 years

• Oncological outcomes of anastomotic leakage

  2 years

• 30 days postoperative morbidity and mortality

  30 days

Study Arms (1)

Rectal cancer patients

OTHER

All patients who will fulfill the inclusions criteria. Patients will undergo formal curative radical Laparoscopic resection for rectal cancer

Procedure: Laparoscopic resection for rectal cancer

Interventions

Laparoscopic resection for rectal cancer PROCEDURE

Formal curative radical laparoscopic rectal resection.

Rectal cancer patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients who undergo laparoscopic resection for biopsy proven rectal cancer.

You may not qualify if:

• Open surgery,
• Emergency intervention,
• Palliative resection,
• Stage IV with distant metastasis,
• Recurrent cancer,
• Multivisceral resection

Sponsors & Collaborators

• Mansoura University: lead
• University of Rome Tor Vergata: collaborator

Study Sites (2)

Mansoura University Hospitals

Al Mansurah, Al Dakhlia, 35516, Egypt

Location

Policlinico Tor Vergata Hospital

Rome, 00133, Italy

Location

MeSH Terms

Conditions

Anastomotic Leak; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Mostafa Shalaby, M,D., MSc.

  Mansoura University/ University of Rome Tor Vergata

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: March 12, 2016
• First Posted: March 24, 2016
• Study Start: June 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: June 1, 2017
• Last Updated: May 29, 2020

Record last verified: 2020-05

Locations

EG (1); IT (1)