Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01786694
Other study ID # PI2012_843_0022
Secondary ID 2012-A01218-35
Status Completed
Phase Phase 3
First received February 1, 2013
Last updated January 31, 2017
Start date October 2013
Est. completion date November 2014

Study information

Verified date January 2017
Source Centre Hospitalier Universitaire, Amiens
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this pilot study is to evaluate the feasibility of microdialysis by laparoscopy in order to identify anastomotic leaks after rectal surgery.


Recruitment information / eligibility

Status Completed
Enrollment 11
Est. completion date November 2014
Est. primary completion date October 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- rectal disease requiring proctectomy with anastomosis and stomy

- proctectomy by laparoscopy

- written consent

Exclusion Criteria:

- history of colorectal surgery

- rectal surgery without anastomosis

- breastfeeding or pregnancy

- ASA score IV

Study Design


Related Conditions & MeSH terms


Intervention

Device:
cma microdialysis catheter placement
the microdialysis catheters are sold by CMA

Locations

Country Name City State
France Amiens University Hospital Amiens

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

References & Publications (3)

Deeba S, Corcoles EP, Hanna GB, Pareskevas P, Aziz O, Boutelle MG, Darzi A. Use of rapid sampling microdialysis for intraoperative monitoring of bowel ischemia. Dis Colon Rectum. 2008 Sep;51(9):1408-13. doi: 10.1007/s10350-008-9375-4. Erratum in: Dis Colon Rectum. 2008 Nov;51(11):1741. Hanna, B G [corrected to Hanna, G B]. — View Citation

Högberg N, Carlsson PO, Hillered L, Meurling S, Stenbäck A. Intestinal ischemia measured by intraluminal microdialysis. Scand J Clin Lab Invest. 2012 Feb;72(1):59-66. doi: 10.3109/00365513.2011.629307. — View Citation

Verdant CL, Chierego M, De Moor V, Chamlou R, Creteur J, de Dieu Mutijima J, Loi P, Gelin M, Gullo A, Vincent JL, De Backer D. Prediction of postoperative complications after urgent laparotomy by intraperitoneal microdialysis: A pilot study. Ann Surg. 2006 Dec;244(6):994-1002. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary functional success of microdialysis the functional success of microdialysis is defined as abnormal values localised at the microdialysis catheter postoperative day 5
Secondary anastomotic leaks rate the anastomotic leaks rate is defined as the number of anastomotic leaks validated by a CT scan postoperative day 30
Secondary superficial surgical site infection rate the surgical site infection rate is defined as the number of infection near the incision postoperative day 30
Secondary the mortality rate the mortality rate is defined as the number of death after the surgery postoperative day 30
Secondary the quality of life after the surgery the quality of life will be evaluated with the QLQ C30 CR 29 prior to the surgery, at the hospital discharge and on postoperative day 30 postoperative day 30
See also
  Status Clinical Trial Phase
Recruiting NCT06380101 - Evaluating a Nonessential Amino Acid Restriction (NEAAR) Medical Food With Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer (LARC) N/A
Active, not recruiting NCT05551052 - CRC Detection Reliable Assessment With Blood
Recruiting NCT04323722 - Impact of Bladder Depletion on Mesorectal Movements During Radiotherapy in Rectal Cancer N/A
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT04088955 - A Digimed Oncology PharmacoTherapy Registry
Active, not recruiting NCT01347697 - Collagen Implant (Biological Mesh) Versus GM Flap for Reconstruction of Pelvic Floor After ELAPE in Rectal Cancer N/A
Recruiting NCT04495088 - Preoperative FOLFOX Versus Postoperative Risk-adapted Chemotherapy in Patients With Locally Advanced Rectal Cancer Phase 3
Withdrawn NCT03007771 - Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia Phase 1
Terminated NCT01347645 - Irinotecan Plus E7820 Versus FOLFIRI in Second-Line Therapy in Patients With Locally Advanced or Metastatic Colon or Rectal Cancer Phase 1/Phase 2
Not yet recruiting NCT03520088 - PROSPECTIVE CONTROLLED AND RANDOMIZED STUDY OF THE GENITOURINARY FUNCTION AFTER RECTAL CANCER SURGERY IN RELATION TO THE DISSECTION OF THE INFERIOR MESENTERIC VESSELS N/A
Recruiting NCT05556473 - F-Tryptophan PET/CT in Human Cancers Phase 1
Recruiting NCT04749381 - The Role of TCM on ERAS of Rectal Cancer Patients Phase 2
Enrolling by invitation NCT05028192 - Mitochondria Preservation by Exercise Training: a Targeted Therapy for Cancer and Chemotherapy-induced Cachexia
Recruiting NCT03283540 - Transanal Total Mesorectal Excision for Rectal Cancer on Anal Physiology + Fecal Incontinence
Completed NCT04534309 - Behavioral Weight Loss Program for Cancer Survivors in Maryland N/A
Recruiting NCT05914766 - An Informational and Supportive Care Intervention for Patients With Locally Advanced Rectal Cancer N/A
Recruiting NCT04852653 - A Prospective Feasibility Study Evaluating Extracellular Vesicles Obtained by Liquid Biopsy for Neoadjuvant Treatment Response Assessment in Rectal Cancer
Recruiting NCT03190941 - Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients Phase 1/Phase 2
Completed NCT02810652 - Perioperative Geriatrics Intervention for Older Cancer Patients Undergoing Surgical Resection N/A
Terminated NCT02933944 - Exploratory Study of TG02-treatment as Monotherapy or in Combination With Pembrolizumab to Assess Safety and Immune Activation in Patients With Locally Advanced Primary and Recurrent Oncogenic RAS Exon 2 Mutant Colorectal Cancer Phase 1