A Prospective Feasibility Study for TAMIS

NCT02626728 | Completed DMC

• 1 other identifier: 123-TAMIS
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Most recently, the Transanal Minimally Invasive Surgery (TAMIS) approach combined with single-port technology has allowed that pelvic surgery can be laparoendocopically performed from both its abdominal and perineal aspects.Previously, a strong negative association between medium- and long-term survival and male gender with narrow pelvis have been reported. TAMIS has a significant potantial for improving the quality of the surgical resection of rectal tumors in men with visceral obesity and narrow pelvis. This group of patients have also a high rate of conversion to open surgery. Focusing on improvement in intraoperative conditions and surgical techniques rather than routine conventional procedures may be the way to go concerning favorable short- and long-term outcomes. The selection of adequate surgical approach to the high-risk patients with visceral obesity and a bulky mesentery may prevent or limit the risk for anastomotic leakage and improve oncologic margin clearence. This is a prospective observational feasability study of the TAMIS-procedure.

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• morbidity

  Clavien-Dindo

  30-days

Secondary Outcomes (2)

• mortality

  30-days

• short-term oncological result

  30-days

Interventions

laparoscopic assisted transanal surgery (TAMIS) PROCEDURE

all patients included recieve laparoscopic assisted transanal minimally invasive surgery

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients with a solitary rectal cancer, who is eligible for surgery. Patients with rectal cancer (T1-3 stages verified by MRI), regardless regional lymph-node status and distant metastasis, will be offered the operative procedure with TAMIS technique.

You may qualify if:

• rectal cancer with histological diagnosis
• tumors located between 10 - 4 cm from the anal verge measured with a rigid rectoscope.
• suitable for elective resection

You may not qualify if:

• preoperative magnetic resonance imaging (MRI) showing diameter of tumor size \>6 cm
• American Society of Anesthesiologists (ASA) class IV and V
• anticipated need of intensive care unit (ICU)
• history of previous major abdominal surgery
• computer assisted tomography (CT) or MRI evidence of tumor infiltration of adjacent organs
• obese patient with body mass index \>35kg/m2
• those, who do not understand the requirements of the protocol
• pregnancy
• more than one colorectal tumor

Sponsors & Collaborators

• Hvidovre University Hospital: lead

Study Sites (1)

Hvidovre Hospital University of Copenhagen

Hvidovre, 2650, Denmark

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Transanal Endoscopic Surgery

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

Intervention Hierarchy (Ancestors)

Natural Orifice Endoscopic Surgery; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Proctoscopy; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Mette W Christoffersen, M.D, PhD

  Hvidovre Hospital University of Copenhagen

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D, PhD

Study Record Dates

• First Submitted: December 8, 2015
• First Posted: December 10, 2015
• Study Start: September 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: October 1, 2016
• Last Updated: November 22, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)