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Compares treatment options for Rectal Neoplasms Malignant
Official title Transanal Versus Laparoscopic Total Mesorectal Excision for Rectal Cancer
ClinicalTrials.gov ID: NCT02966483
What this study is testing
- What it's testing
- Laparoscopic surgery for rectal cancer has been successfully proven to be a non-inferior alternative regarding resection quality, and oncological outcomes of patients as compared to open surgery in mangy clinical trails. Moreover, laparoscopic surgery is advantageous over open surgery with regard to operative invasiveness, patient's recovery, and wound related complications.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- histologically proven rectal adenocarcinoma;
- tumor located below the level of peritoneal reflection ;
- diagnosis of rectal cancer amenable to curative surgery;
- no evidence of distant metastases;
- preoperative tumor stage within III;
You likely can't join if
- could not perform sphincter preservation surgery (requiring a Mile's procedure);
- T4b tumor invading adjacent organs;
- T1 tumors that can be locally resected
- should take neoadjuvant therapy but refuse it;
- recurrent cancer;
- concurrent or previous diagnosis of invasive cancer within 5 years;
See the full eligibility criteria
- histologically proven rectal adenocarcinoma;
- tumor located below the level of peritoneal reflection ;
- diagnosis of rectal cancer amenable to curative surgery;
- no evidence of distant metastases;
- preoperative tumor stage within III;
- no threaten mesorectal fascia (MRF)after neoadjuvant therapy;
- no contraindication to laparoscopic surgery;
- without history of other malignancies;
- Written informed consent
- could not perform sphincter preservation surgery (requiring a Mile's procedure);
- T4b tumor invading adjacent organs;
- T1 tumors that can be locally resected
- should take neoadjuvant therapy but refuse it;
- recurrent cancer;
- concurrent or previous diagnosis of invasive cancer within 5 years;
- emergent surgery with intestinal obstruction or perforation;
- history of colorectal surgery;
- fecal incontinence;
- history of inflammatory bowel disease;
- with contraindications to general anaesthesia(ASA class 4 or 5);
- pregnant or breast-feeding;
- history of mental disorder
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Guangzhou, Guangdong, China
- Zhanjiang, Guangdong, China
- Zunyi, Guizhou, China
- Changsha, Hunan, China
- Hengyang, Hunan, China
- Changchun, Jilin, China
- Shenyang, Liaoning, China
- Xi'an, Shaanxi, China
- Shanghai, Shanghai Municipality, China
- Nanchong, Sichuan, China
- Yibin, Sichuan, China
- Chongqing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Chongqing, Chongqing Municipality, China; Guangzhou, Guangdong, China; Zhanjiang, Guangdong, China; Zunyi, Guizhou, China; Changsha, Hunan, China and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.