Rectum CancerNCT05201872
Bacteriological Differences Between Transanal and Laparoscopic Total Mesorectal Excision for Rectal Cancer.
An observational study of Rectum Cancer, run by Yanhong Deng at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectum Cancer
- How many people
- 216 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2022to Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 216 rectal cancer patients will be enrolled. Patients must be older than 18 years.
Who may be able to join
- Primary rectal carcinoma
- Single lesion
- No metastasis
Who cannot join
- History of malignant tumors
- Acute bowel obstruction, bleeding or perforation
- Tumor over 6cm in diameter or in severe adhesion with surrounded tissues
- Severe other contradictions of surgery
- Pregnant women will be excluded
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of colorectal surgery, the Sixth Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510655
Liang Huang, MD, PhD, 15989101216, huangl75@mail.sysu.edu.cn
About this study
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.
Read the detailed 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.
- Conditions
- Rectum Cancer
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic surgery | Different surgical methods for rectal cancer resection | |
| Transanal endoscopic surgery | Different surgical methods for rectal cancer resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The positive rate of bacterial contamination of peritoneal washings
Bacterial contamination positive rate determined by bacterial culture of intra-operative peritoneal washings
Measured: 1 years
Secondary outcomes (1)
Postoperative complications
Determine whether patients have postoperative complications after surgery
Measured: a month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start15 Jan 2022
- Primary completionFeb 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectum CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yanhong Deng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yanhong Deng, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05201872
- Sponsor's protocol ID
- GIHSYSU-21
- Status last verified
- Jan 2022
- First submitted
- 20 Jan 2022
- Last updated
- 7 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacteriological Differences Between Transanal and Laparoscopic Total Mesorectal Excision for Rectal Cancer.
- ClinicalTrials.gov ID
- NCT05201872
- Acronym / sponsor ID
- GIHSYSU-21
- Conditions
- Rectum Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Yanhong DengUniversity, hospital or other
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 21 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laparoscopic surgery | – | –Different surgical methods for rectal cancer resection |
| Transanal endoscopic surgery | – | –Different surgical methods for rectal cancer resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 216 rectal cancer patients will be enrolled. Patients must be older than 18 years.
Key inclusion criteria (3 listed)
- Primary rectal carcinoma
- Single lesion
- No metastasis
Key exclusion criteria (5 listed)
- History of malignant tumors
- Acute bowel obstruction, bleeding or perforation
- Tumor over 6cm in diameter or in severe adhesion with surrounded tissues
- Severe other contradictions of surgery
- Pregnant women will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The positive rate of bacterial contamination of peritoneal washings
Time frame: 1 years
Bacterial contamination positive rate determined by bacterial culture of intra-operative peritoneal washings
1 secondary outcome
Postoperative complications
Time frame: a month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectum Cancer, run by Yanhong Deng at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liang Huang (15989101216, huangl75@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The positive rate of bacterial contamination of peritoneal washings (time frame: 1 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2022.