Peritoneal Microdialysis in Patients Undergoing Low Anterior Resection (LAR) for Recto-sigmoid Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-01-31

Study Completion Date

2008-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Anastomotic leakage is a serious complication after LAR with high morbidity and mortality rates. Early diagnosis and treatment is mandatory. The primary aim of the present study is to investigate the clinical use of peritoneal microdialysis and whether is able to detect anastomotic leakage prior to clinical symptoms develops.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Peritoneal Microdialysis in Patients Undergoing Low Anterior Resection for Rectum Cancer

NCT01062334

Cancer

UNKNOWN NA

Quantification of Anastomostic Blood Flow With Fluorescence Imaging in Low Anterior Resection for Rectal Cancer

NCT05627934

Anastomotic Leak

NOT_YET_RECRUITING

Feasibility of Microdialysis by Laparoscopy

NCT01786694

Rectal Cancer

COMPLETED PHASE3

Monitoring by Microdialysis of Postoperative Complications After Proctectomy

NCT01999634

Rectal Cancer

COMPLETED PHASE3

Transrectal Vacuum Assisted Drainage: A New Method of Treating Anastomotic Leakage After Rectal Resection

NCT00773981

Colorectal Surgery

UNKNOWN PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Patients undergoing LAR for recto-sigmoid cancer is subjected to peritoneal microdialyses during the postoperative period until discharge. Subcutaneous microdialysis serve as control. Samples are collected every 4-hour. Samples will be analyzed continuously but the results will not be included in the clinical evaluation of the patient.

Patients undergoing abdomino-perineal rectal resection will serve as a control group.

A total of 50 patients will be included in this pilot study. The results of the peritoneal microdialyses will be compared with the clinical course in each patient. The results form the uncomplicated courses will be used to define the normal variations in peritoneal microdialysis. This will be compared to results from patients with various complications.

The study is approved by the local scientific ethical committee No. ------

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer of Rectum

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Histological verified cancer
* The cancer must be located in rectum or the sigmoid colon
* Diverting stoma is allowed
* Perioperative radio-chemotherapy is allowed