Clinical Trials Logo

Clinical Trial Summary

The primary purpose of this study is to compare the differences of bacteriological in rectal cancer patients undergoing laparoscopic or transanal endoscopy radical resection. The secondary purpose is to compare the effects of two different surgical methods on postoperative complications.


Clinical Trial Description

Transanal total mesorectal excision (taTME) is a new surgical procedure for total mesorectal excision (TME) by dissociating the mesorectum from the bottom through transanal endoscopic. The characteristics of TaTME are mainly summarized as transanal reverse operation, no auxiliary abdominal incision, complete mesorectal excision and specimen removal through the anus. So taTME is a natural orifice specimen extraction procedure (NOSES). Compared with traditional laparoscopy, taTME has obvious oncological and technical advantages. However, similar to NOSES, the specific surgical approach to taTME may induces bacteriological safety concerns. Whether TaTME is safe and feasible still needs strong evidence-based medical evidence. However, there have been prospective studies related to bacteriology in NOSES surgery, but there is a lack of prospective clinical studies on the issue of bacteriological diffusion during taTME surgery. Bacterial contamination of the peritoneal cavity is common in laparoscopic surgery for colorectal cancer. Although the standard NOSES procedure avoids bacteriological problems through the use of antibiotics, surgical peritoneal irrigation, and the use of sterile specimen bags, its safety remains inconclusive. Therefore, compared with conventional laparoscopic colorectal cancer surgery, taTME not only takes specimens from the natural orifice, but also requires further prospective studies on whether the incision of the intestinal wall from the mucosa during the operation will violate the aseptic principle, the aseptic safety of taTME still needs further prospective studies to confirm. Therefore, the investigators conducted a randomized controlled study to collect the abdominal and pelvic irrigation fluids in the transanal and laparoscopic TME surgery for bacteriological examination, to clarify the influence of the two different surgical methods on the intraoperative bacterial diffusion. The purpose of this study was to clarify the influence of two different surgical methods on the intraoperative bacterial spread, and to provide more evidence-based medical evidence for the safety of taTME surgery. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05201872
Study type Observational
Source Sun Yat-sen University
Contact Liang Huang
Phone 15989101216
Email [email protected]
Status Recruiting
Phase
Start date January 15, 2022
Completion date April 2023

See also
  Status Clinical Trial Phase
Completed NCT00409994 - Safety Study of Rapamycin Administered Before and During Radiotherapy to Treat Rectum Cancer Phase 1/Phase 2
Completed NCT04371198 - Patient-Derived Organoids for Rectal Cancer N/A
Recruiting NCT05001282 - A Study to Evaluate ELU001 in Patients With Solid Tumors That Overexpress Folate Receptor Alpha (FRĪ±) Phase 1/Phase 2
Recruiting NCT05305820 - Perioperative Exercise and Nutritional Optimisation Prehabilitation Before Surgery for Patients With Peritoneal Malignancy N/A
Recruiting NCT03699761 - The Role of Pelvic Peritonization in Laparoscopic or Robotic Low Anterior Resection N/A
Recruiting NCT04907643 - Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes Phase 2
Recruiting NCT03843957 - Effectiveness and Implementation of mPATH-CRC N/A
Completed NCT02423226 - Computed Tomography-guided Brachytherapy Plus Chemotherapy for Locally Recurrent Rectum Cancer Phase 2
Completed NCT00379743 - Partnership for Healthy Seniors N/A
Completed NCT00509444 - Cancer Prevention and Treatment Among African American Older Adults: Treatment Trial Phase 3
Not yet recruiting NCT05400122 - Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer Phase 1
Recruiting NCT02738359 - Efficacy of Colonoscopy, Colon Capsule and Fecal Immunological Test for Colorectal Cancer Screening
Recruiting NCT02997553 - Fluorescence for Sentinel Lymph Node Identification in Cancer Surgery Phase 3
Active, not recruiting NCT02458664 - BASE HSP110 : A New Therapeutic Target and a New Marker for Prognosis of Type MSI Colorectal Cancer N/A
Withdrawn NCT03257332 - Determining Early Development of Faecal Incontinence and Anorectal Muscle Function After Surgery for Rectal Cancer.
Completed NCT02641691 - Non-Operative Radiation Management of Adenocarcinoma of the Lower Rectum Phase 2
Recruiting NCT04405206 - Total Neoadjuvant Therapy Followed by 'Watch and Wait' Approach or Organ Preservation for Low-risk Rectal Cancer
Recruiting NCT03573791 - Biomarkers for Predicting Neoadjuvant Chemoradio-resistance for Middle-low Advanced Rectal Cancer
Completed NCT02079389 - The Value of Laparoscopic Ultrasound in Patients Undergoing Laparoscopic Resection for Cancer of the Colon or Rectum N/A
Recruiting NCT05411783 - Low Tie Versus High Tie of the Inferior Mesenteric Vein During Colorectal Cancer Surgery: A Randomized Clinical Trial N/A